A Study to Assess Whether Etrolizumab is a Safe and Effic... | NCT02394028 | Trialant
NCT02394028
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Nov 16, 2022Actual
Enrollment
1,035Actual
Phase
Phase 3
Conditions
Crohn Disease
Interventions
Etrolizumab
Placebo
Countries
United States
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Croatia
Czechia
Estonia
France
Germany
Hungary
Israel
Italy
Latvia
Lithuania
Mexico
Netherlands
New Zealand
Poland
Romania
Russia
Serbia
Slovakia
South Africa
South Korea
Spain
Switzerland
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02394028
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GA29144
Secondary IDs
ID
Type
Description
Link
2014-003824-36
EudraCT Number
Brief Title
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Acronym
BERGAMOT
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 20, 2015Actual
Primary Completion Date
Sep 7, 2021Actual
Completion Date
Sep 7, 2021Actual
First Submitted Date
Feb 27, 2015
First Submission Date that Met QC Criteria
Mar 16, 2015
First Posted Date
Mar 20, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 1, 2022
Results First Submitted that Met QC Criteria
Oct 21, 2022
Results First Posted Date
Nov 16, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 21, 2022
Last Update Posted Date
Nov 16, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.
The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Drug: Etrolizumab
Drug: Placebo
Induction Phase - Cohort 1 (Exploratory): Placebo
Placebo Comparator
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Week 14
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Week 14
Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Week 14
Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
Week 14
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Maintenance phase participants were evaluated.
Baseline and Week 66
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Secondary Outcomes
Measure
Description
Time Frame
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Week 6
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
Use of effective contraception as defined by the protocol
Exclusion Criteria:
A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
Planned surgery for CD
Ileostomy or colostomy
Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
Any prior treatment with ustekinumab within 14 weeks prior to randomization
Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)
Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])
Any major episode of infection requiring treatment with intravenous antibiotics ≤8 weeks prior to screening or oral antibiotics ≤4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
Hospitalization (other than for elective reasons) within 4 weeks prior to randomization
A total of 1035 participants entered the study across induction cohorts 1-3, a subset of 487 patients moved into the maintenance phase of the study.
Recruitment Details
At the time of study closure, a total of 1035 patients were randomized into the induction phase, enrolled sequentially across Cohorts 1, 2, and 3. The final sample size for the pivotal induction Cohort 3 was lower than the 496 patients planned per the final protocol due to the early closure of the study. Cohorts below are mutually exclusive.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Periods
Title
Milestones
Reasons Not Completed
Induction Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 24, 2019
Sep 1, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Luxembourg
Sweden
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Drug: Etrolizumab
Drug: Placebo
Induction Phase - Cohort 3 (Pivotal): Placebo
Placebo Comparator
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Drug: Placebo
Maintenance Phase - Placebo Responders: Placebo
Placebo Comparator
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.
Week 66
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Week 6
Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Week 14
Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Week 14
Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Baseline and Week 14
Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Baseline and Week 14
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
Baseline, Weeks 14 and 66
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
Baseline and Week 66
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included
Baseline, Weeks 14 and 66
Maintenance Phase: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
Week 66
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included
Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported.
Induction Phase Cohorts are not included
Baseline and from Week 14 up to Week 66
Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
Baseline and Week 66
Overall Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.
From Baseline up to Week 78
Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Number of participants who discontinued the study due to the adverse events is reported.
From Baseline up to Week 78
Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'
From Baseline up to Week 78
Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once
From Baseline up to Week 78
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
From Baseline up to Week 78
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
From Baseline up to Week 78
Overall Number of Participants Who Develop Malignancies
Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)
From Baseline up to Week 78
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose
Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)
Observed Trough Serum Concentration (Ctrough) of Etrolizumab
Serum Etrolizumab Trough Concentration
Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66
La Jolla
California
92093-5354
United States
VA Long Beach Healthcare System
Long Beach
California
90822
United States
Digestive Care Associates, A Medical Corporation
San Carlos
California
94070
United States
SDG Clinical Research
San Diego
California
92103
United States
University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
Riga East Clinical University Hospital; Clinic Gailezers
Riga
LV 1002
Latvia
Pauls Stradins Clinical University Hospital
Riga
LV-1002
Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas
50009
Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
Vilnius
LT-08661
Lithuania
Clinical Research Institute
Tlalnepantla
Mexico CITY (federal District)
54055
Mexico
Medical Care & Research SA de CV
Mérida
Yucatán
97070
Mexico
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam
1081 HV
Netherlands
Amsterdam UMC Location AMC
Amsterdam
1105 AZ
Netherlands
Leids Universitair Medisch Centrum
Leiden
2333 ZA
Netherlands
Maastricht University Medical Center
Maastricht
6229 HX
Netherlands
Erasmus Medisch Centrum
Rotterdam
3000 CA
Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen
6162 BG
Netherlands
ETZ TweeSteden
Tilburg
5042AD
Netherlands
North Shore Hospital
Auckland
0620
New Zealand
Christchurch Hospital NZ
Christchurch
8011
New Zealand
Dunedin Public Hospital
Dunedin
9016
New Zealand
Waikato Hospital
Hamilton
3248
New Zealand
Shakespeare Specialist Group
Takapuna
0620
New Zealand
Tauranga Hospital
Tauranga
3143
New Zealand
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok
15-275
Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz
85-312
Poland
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
Elblag
82-300
Poland
ETG Kielce
Kielce
25-355
Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów
95-054
Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lublin
20-015
Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ
34-400
Poland
Centrum Medyczne "MEDYK"
Rzeszów
35-055
Poland
Gabinet Lekarski, Bartosz Korczowski
Rzeszów
35-302
Poland
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
Sopot
81-756
Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin
70-351
Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin
71-434
Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun
87-100
Poland
Centrum Zdrowia MDM
Warsaw
00-631
Poland
Warsaw IBD Point Profesor Kierkus
Warsaw
00-728
Poland
Zespó Przychodni Specjalistycznych PRIMA
Warsaw
02-018
Poland
PlanetMed sp. z o.o.
Wroclaw
52-210
Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw
53-114
Poland
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw
54-144
Poland
S.C MedLife S.A
Bucharest
010719
Romania
Spitalul Clinic Colentina
Bucharest
772202
Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara
300002
Romania
Yusupov Hospital
Moskva
Adygeya Republic
127015
Russia
LLC "Novosibirsk GastroCenter"
Novosibirsk
Altaj
630007
Russia
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
Saint Petersburg
Sankt-Peterburg
191015
Russia
Baltic Medicine
Saint Petersburg
Sankt-Peterburg
194356
Russia
SBIH City Clinical Hospital #31
Saint Petersburg
Sankt-Peterburg
197110
Russia
SBEI HPE Altai StateMedicalUniversityofMoH andSD
Barnaul
656050
Russia
Irkutsk State Medical Academy of Continuing Education
Irkutsk
Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk
630091
Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk
644013
Russia
Evromedservis LCC
Pushkin
196603
Russia
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don
344022
Russia
Federal State Military Educational Institution; High Professional Education Military Medical Acad
Saint Petersburg
194044
Russia
Clinical Helth Centre Zvezdara
Belgrade
11000
Serbia
Military Medical Academy
Belgrade
11040
Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade
11080
Serbia
Clinical Center of Vojvodina
Novi Sad
21000
Serbia
General Hospital Djordje Joanovic
Zrenjanin
23000
Serbia
IBDcentrum s.r.o.
Bratislava
83104
Slovakia
KM Management spol. s r.o.
Nitra
94901
Slovakia
Accout Center s.r.o.
Šahy
936 01
Slovakia
Endomed, s.r.o.
Vranov nad Topľou
093 01
Slovakia
Dr D Epstein Practice
Cape Town
7405
South Africa
Emmed Research
Pretoria
0002
South Africa
Inje University Busan Paik Hospital
Busan
47392
South Korea
Dong-A University Hospital
Busan
49201
South Korea
Pusan National University Hospital
Busan
49241
South Korea
Kyungpook National University Hospital
Daegu
41944
South Korea
Yeungnam Univ. Hospital
Daegu
705-717
South Korea
Hanyang University Guri Hospital
Gyeonggi-do
11923
South Korea
Korea University Ansan Hospital
Gyeonggi-do
15355
South Korea
CHA Bundang Medical Centre; CHA university
Seongnam
13520
South Korea
Seoul National University Bundang Hospital
Seongnam-si
13605
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Kangbuk Samsung Hospital
Seoul
03181
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju
220-701
South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
Majadahonda
Madrid
28222
Spain
Hospital Clínic i Provincial; Servicio de Farmacia
Barcelona
08036
Spain
Centro Médico Teknon
Barcelona
Spain
Hospital Reina Sofia; Medical Oncology
Córdoba
14004
Spain
Hospital Juan Ramón Jiménez
Huelva
21005
Spain
Hospital Universitario de la Princesa
Madrid
28006
Spain
Hospital Universitario La Paz
Madrid
280146
Spain
Hospital Universitario de Fuenlabrada
Madrid
28942
Spain
Complejo Hospitalario de Pontevedra
Pontevedra
36071
Spain
Hospital Universitario Virgen Macarena
Seville
41009
Spain
Hospital Universitario Virgen del Rocio
Seville
41013
Spain
Hospital Universitari i Politecnic La Fe
Valencia
46026
Spain
Hospital Universitario Miguel Servet
Zaragoza
50009
Spain
Inselspital-Universitaetsspital Bern
Bern
3010
Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern
3012
Switzerland
Universitätsspital Zürich
Zurich
8091
Switzerland
Ankara University Medical Faculty
Ankara
06100
Turkey (Türkiye)
Hacettepe University Medical Faculty; Gastroenterology
Ankara
06100
Turkey (Türkiye)
Gazi University Medical Faculty
Ankara
06500
Turkey (Türkiye)
Acibadem Fulya Hospital; Neurology
Istanbul
34349
Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital; Medical Oncology
Istanbul
34668
Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
Istanbul
34722
Turkey (Türkiye)
Ege University Medical Faculty
Izmir
35100
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
Kocaeli
41380
Turkey (Türkiye)
Acibadem Kozyatagi Hospital; Gastroenterology
Kozyataği
34742
Turkey (Türkiye)
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv
Kharkiv Governorate
61037
Ukraine
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
Kharkiv
Kharkiv Governorate
61204
Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv
KIEV Governorate
1023
Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv
KIEV Governorate
2091
Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv
KIEV Governorate
4073
Ukraine
Lviv Regional Clinical Hospital
Lviv
KIEV Governorate
79010
Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk
Kuban People's Republica
76000
Ukraine
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
Chernivtsi
Podolia Governorate
58002
Ukraine
Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
Kremenchuk
Poltava Governorate
39617
Ukraine
CI City Hospital #1
Zaporizhzhia
Tavria Okruha
69104
Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv
61039
Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv
61124
Ukraine
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv
01030
Ukraine
City Hospital #1
Mykolaiv
54003
Ukraine
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
Odesa
65059
Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia
21001
Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia
21018
Ukraine
MCIC MC LLC Health Clinic
Vinnytsia
21029
Ukraine
LLC Diaservis
Zaporizhzhia
69106
Ukraine
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
University Hospital Coventry
Coventry
CV2 2DX
United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Queen Elizabeth Hospital
Kings Lynn
PE30 4ET
United Kingdom
St James University Hospital
Leeds
LS9 7TF
United Kingdom
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
Whipps Cross Hospital
London
E11 1NR
United Kingdom
University College London Hospital
London
NW1 - 2PG
United Kingdom
Fairfield General Hospital
Manchester
M8 5RB
United Kingdom
Royal Victoria Infirmary; Stroke unit
Newcastle upon Tyne
NE1 4LP
United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Royal Wolverhampton hospital; McHale Building
Wolverhampton
WV10 0QP
United Kingdom
Derived
Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through alpha4beta7 and alphaEbeta7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17.
Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
FG001
Etrolizumab 105mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG002
Etrolizumab 210mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG003
Etrolizumab 105mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG004
Etrolizumab 210mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG005
Placebo Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
FG006
Etrolizumab 105mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG007
Etrolizumab 210mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
FG008
Placebo/Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
FG009
Etrolizumab/Placebo
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who were re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
FG010
Etrolizumab/Etrolizumab 105mg
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who were re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
FG00059 subjects
FG001120 subjects
FG002121 subjects
FG003176 subjects
FG004174 subjects
FG00597 subjects
FG006143 subjects
FG007145 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00052 subjects
FG001104 subjects
FG002108 subjects
FG003141 subjects
FG004145 subjects
FG00580 subjects
FG006118 subjects
FG007114 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0007 subjects
FG00116 subjects
FG00213 subjects
FG00335 subjects
FG00429 subjects
FG00517 subjects
FG00625 subjects
FG00731 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG0032 subjects
FG0045 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0003 subjects
FG0016 subjects
FG0022 subjects
FG00317 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Non-compliance
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0036 subjects
FG004
Early withdrawal and roll over to a different study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Sponsor decision
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Technical reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
:ack of calculation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0010 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0020 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0030 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0040 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0050 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0060 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG0070 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive either placebo or etrolizumab 105 mg.
FG00853 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive placebo.
FG009217 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive placebo.
FG010217 subjectsParticipants from the induction phase who had achieved a CDAI-70 response without the use of rescue therapy were enrolled in the maintenance phase to receive etrolizumab 105 mg.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Population: All participants randomized who received at least one dose of study treatment, grouped under the treatment arm received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
BG001
Etrolizumab 105mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG002
Etrolizumab 210mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG003
Etrolizumab 105mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG004
Etrolizumab 210mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG005
Placebo Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
BG006
Etrolizumab 105mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG007
Etrolizumab 210mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
BG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00059
BG001120
BG002121
BG003176
BG004174
BG00596
BG006143
BG007145
BG00853
BG009217
BG010217
BG0111521
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Induction Phase: Number analyzed is for participants in induction phase.
Maintenance Phase: Number analyzed is for participants who entered the maintenance phase
Mean
Standard Deviation
Years
Title
Denominators
Categories
Induction Phase
ParticipantsBG00059
ParticipantsBG001120
ParticipantsBG002121
ParticipantsBG003
Sex: Female, Male
Induction Phase: Number analyzed is for participants in induction phase. Maintenance Phase: Number analyzed is for participants who entered the maintenance phase.
Count of Participants
Participants
Title
Denominators
Categories
Induction Phase
ParticipantsBG00059
ParticipantsBG001120
ParticipantsBG002
Ethnicity (NIH/OMB)
Induction Phase: Number analyzed is for participants in induction phase. Maintenance Phase: Number analyzed is for participants who entered the maintenance phase.
Count of Participants
Participants
Title
Denominators
Categories
Induction Phase
ParticipantsBG00059
ParticipantsBG001120
ParticipantsBG002
Race/Ethnicity, Customized
race
Induction Phase: Number analyzed is for participants in induction phase. Maintenance Phase: Number analyzed is for participants who entered the maintenance phase.
Count of Participants
Participants
Title
Denominators
Categories
Induction Phase
ParticipantsBG00059
ParticipantsBG001120
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
mITT - Modified Intent to Treat population: all patients randomized who received at least one dose of study drug, grouped under the randomized treatment arm. Results for Induction Phase Cohort 2 and 3 and Maintenance Phase are not presented.
Posted
Number
90% Confidence Interval
Percentage of Particiapnts
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking. 90%CI
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12. 90%CI
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12. 90%CI
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG00059
OG001120
OG002121
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.9(6.56 to 20.51)
OG00120.00(14.69 to 26.64)
OG00227.3(21.16 to 34.37)
Primary
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
mITT - Modified Intent to Treat population: all patients randomized who received at least one dose of study drug, grouped under the randomized treatment arm. Results for Induction Phase Cohort 1 and Maintenance Phase are not presented.
Posted
Number
95% Confidence Interval
Percentage of Particiapnts
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Primary
Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
mITT. Results for Induction Phase Cohort 2 and 3 and Maintenance Phase are not presented.
Posted
Number
90% Confidence Interval
Percentage of Participants
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Primary
Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
mITT. Results for Induction Phase Cohort 1 and Maintenance Phase are not presented.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Primary
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Maintenance phase participants were evaluated.
mITT. Maintenance Phase Placebo/Placebo cohort is not reported since this is an exploratory population only. Results for the Induction phase populations for cohorts 1-3 are not presented
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline and Week 66
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Primary
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.
mITT. Maintenance Phase Placebo/Placebo cohort is not reported since this is an exploratory population only. Induction Phase population for cohorts 1-3 are not included
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 66
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
mITT. Results for Induction Phase Cohort 2 and 3 and Maintenance Phase are not presented.
Posted
Number
90% Confidence Interval
Percentage of Participants
Week 6
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
mITT. Results for Induction Phase Cohort 1 and Maintenance Phase are not presented.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 6
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
mITT. Results for Induction Phase Cohort 2 and 3 and Maintenance Phase are not presented.
Posted
Number
90% Confidence Interval
Percentage of Participants
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
mITT. Results for Induction Phase Cohort 1 and Maintenance Phase are not presented.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
mITT. Data evaluable participants are included. Results for Induction Phase Cohort 2 and 3 and Maintenance Phase are not presented. Only patients with a baseline score and at least one post-baseline score are included in the analysis
Posted
Least Squares Mean
Standard Error
scores on a scale
Baseline and Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
mITT. Data evaluable participants are included. Results for Induction Phase Cohort 1 and Maintenance Phase are not presented. Only patients with a baseline score and at least one post-baseline score are included in the analysis
Posted
Least Squares Mean
Standard Error
scores on a scale
Baseline and Week 14
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
mITT. Data evaluable participants are included. Placebo/Placebo Maintenance Cohort is not reported since this is an exploratory population only. Results for Induction Phase is not presented.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
mITT. Maintenance Phase Cohorts only. Placebo/Placebo Maintenance Cohort is not reported since this is an exploratory population only. Only patients receiving oral corticosteroids at Baseline are included in the analysis
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included
mITT. Only patients achieving endoscopic improvement at Week 14 are included in the analysis. Results for Induction Phase Cohort is not presented.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Maintenance Phase: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66
Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
mITT. Maintenance Phase Placebo/Placebo are is not reported since this is an exploratory population only. Results for Induction Phase is not presented.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included
mITT. Maintenance Phase Placebo/Placebo arm is not reported since this is an exploratory population only. Results for Induction Phase is not presented.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported.
Induction Phase Cohorts are not included
mITT. Maintenance Phase Placebo/Placebo is arm is not reported since this is an exploratory population only. Results for Induction Phase is not presented. Only patients receiving oral corticosteroids at Baseline are included in the analysis'
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
mITT. Data evaluable participants are included. Only patients with a baseline score and at least one post-baseline score are included in the analysis. The Maintenance Phase Placebo/Placebo arm is not reported since this is an exploratory population only. Results for Induction Phase is not presented.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Overall Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.
Safety Population
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Number of participants who discontinued the study due to the adverse events is reported.
Safety Population
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'
Safety Population
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Secondary
Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once
Safety Population
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Safety Population. Result data evaluable participants are included
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
Safety Population. Result data evaluable participants are included
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Secondary
Overall Number of Participants Who Develop Malignancies
Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)
Safety Population
Posted
Number
Number of Participants
From Baseline up to Week 78
ID
Title
Description
OG000
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose
Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result from at least one sample'. For the induction phase, participants for cohorts 1-3 were pooled across each dose arm. For maintenance phase, participants were grouped according to their induction & maintenance treatment arms
Posted
Number
Percentage of Participants
Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)
ID
Title
Description
OG000
Etro 105mg Induction Only Cohort
Etro 105mg Induction Only Cohort Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8 and 12
OG001
Etro 210mg Induction Only Cohort
Induction only cohort. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8 and 12
Secondary
Observed Trough Serum Concentration (Ctrough) of Etrolizumab
Serum Etrolizumab Trough Concentration
mITT. All participants who received at least one dose of study drug and had evaluable PK data
Posted
Mean
Standard Deviation
microgram/mL
Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66
ID
Title
Description
OG000
Cohort 1 Etrolizumab 105mg
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG001
Cohort 1 Etrolizumab 210mg
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG002
Time Frame
From Baseline up to a maximum of 78 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
0
59
8
59
32
59
EG001
Etrolizumab 105mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
120
20
120
61
120
EG002
Etrolizumab 210mg Cohort 1
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
121
12
121
52
121
EG003
Etrolizumab 105mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
176
18
176
80
176
EG004
Etrolizumab 210mg Cohort 2
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
174
20
174
68
174
EG005
Placebo Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
0
96
8
96
35
96
EG006
Etrolizumab 105mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
143
12
143
65
143
EG007
Etrolizumab 210mg Cohort 3
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
0
145
8
145
45
145
EG008
Placebo/Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
0
53
9
53
33
53
EG009
Etrolizumab/Placebo
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
0
217
33
217
154
217
EG010
Etrolizumab/Etrolizumab 105mg
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
1
217
30
217
147
217
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected120 at risk
EG0021 events1 affected121 at risk
EG0030 events0 affected176 at risk
EG0040 events0 affected174 at risk
EG0050 events0 affected96 at risk
EG0062 events2 affected143 at risk
EG0070 events0 affected145 at risk
EG0081 events1 affected53 at risk
EG0090 events0 affected217 at risk
EG0102 events2 affected217 at risk
Abdominal pain
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected120 at risk
EG0022 events2 affected121 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0009 events6 affected59 at risk
EG00112 events12 affected120 at risk
EG0027 events7 affected121 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Vomiting
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pyrexia
General disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Urinary tract infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Headache
Nervous system disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Acute vestibular syndrome
Ear and labyrinth disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Optic neuropathy
Eye disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Anal fistula
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Colitis
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Constipation
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastritis
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Ileal stenosis
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Ileus
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Intestinal fistula
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Proctitis
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Subileus
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Chest pain
General disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Granuloma
General disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Drug hypersensitivity
Immune system disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Abdominal abscess
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Abdominal wall abscess
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Abscess intestinal
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Anal abscess
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Appendicitis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Asymptomatic COVID-19
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Cellulitis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Clostridium difficile infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Device related infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastroenteritis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastroenteritis viral
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastrointestinal infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Herpes zoster
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Meningitis listeria
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pilonidal cyst
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pneumonia
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pyelonephritis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Rectal abscess
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Sepsis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Septic shock
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Staphylococcal infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Subcutaneous abscess
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Viral infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Procedural intestinal perforation
Injury, poisoning and procedural complications
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Blood creatinine increased
Investigations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Liver function test abnormal
Investigations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Cerebral gas embolism
Nervous system disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Tremor
Nervous system disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Renal colic
Renal and urinary disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Renal failure
Renal and urinary disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0022 events1 affected121 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Removal of foreign body from gastrointestinal tract
Surgical and medical procedures
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Deep vein thrombosis
Vascular disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Peripheral embolism
Vascular disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0013 events3 affected120 at risk
EG0022 events2 affected121 at risk
EG0030 events0 affected176 at risk
EG0045 events5 affected174 at risk
EG0052 events2 affected96 at risk
EG0065 events5 affected143 at risk
EG0074 events4 affected145 at risk
EG0082 events2 affected53 at risk
EG00911 events10 affected217 at risk
EG01012 events11 affected217 at risk
Abdominal pain
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0017 events6 affected120 at risk
EG00212 events10 affected121 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG00014 events12 affected59 at risk
EG00112 events9 affected120 at risk
EG0029 events8 affected121 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0012 events2 affected120 at risk
EG0023 events3 affected121 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0015 events5 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0002 events1 affected59 at risk
EG0012 events1 affected120 at risk
EG0020 events0 affected121 at risk
EG003
Nausea
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0004 events4 affected59 at risk
EG0018 events7 affected120 at risk
EG00214 events8 affected121 at risk
EG003
Vomiting
Gastrointestinal disorders
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0019 events7 affected120 at risk
EG0028 events6 affected121 at risk
EG003
Fatigue
General disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0014 events4 affected120 at risk
EG0023 events3 affected121 at risk
EG003
Injection site erythema
General disorders
MeDRA version 24.0
Systematic Assessment
EG0005 events3 affected59 at risk
EG00112 events5 affected120 at risk
EG0027 events3 affected121 at risk
EG003
Pyrexia
General disorders
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected120 at risk
EG0024 events4 affected121 at risk
EG003
Influenza
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0012 events2 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Nasopharyngitis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0017 events7 affected120 at risk
EG00213 events9 affected121 at risk
EG003
Sinusitis
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected120 at risk
EG0022 events2 affected121 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0003 events3 affected59 at risk
EG0016 events6 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Urinary tract infection
Infections and infestations
MeDRA version 24.0
Systematic Assessment
EG0000 events0 affected59 at risk
EG0013 events3 affected120 at risk
EG0027 events6 affected121 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0002 events2 affected59 at risk
EG0016 events6 affected120 at risk
EG00210 events10 affected121 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MeDRA version 24.0
Systematic Assessment
EG0001 events1 affected59 at risk
EG0013 events3 affected120 at risk
EG0024 events4 affected121 at risk
EG003
Headache
Nervous system disorders
MeDRA version 24.0
Systematic Assessment
EG0005 events4 affected59 at risk
EG00114 events13 affected120 at risk
EG00210 events7 affected121 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MeDRA version 24.0
Systematic Assessment
EG0003 events2 affected59 at risk
EG0012 events2 affected120 at risk
EG0021 events1 affected121 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003176
OG004174
OG00596
OG006143
OG007145
OG0080
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG00329.5(23.30 to 36.66)
OG00429.3(23.05 to 36.46)
OG00529.2(21.02 to 38.92)
OG00630.1(23.16 to 38.03)
OG00733.1(25.97 to 41.11)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG005
OG006
Cochran-Mantel-Haenszel
0.8508
The multiplicity adjusted p-values are presented.
Difference in rate
1.1
2-Sided
95
-10.85
12.56
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG005
OG007
Cochran-Mantel-Haenszel
0.5235
The multiplicity adjusted p-values are presented.
Difference in rate
3.8
2-Sided
95
-8.30
15.27
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003176
OG004174
OG00596
OG006143
OG007145
OG0080
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG00320.8(14.81 to 26.86)
OG00422.2(16.02 to 28.35)
OG00521.6(13.24 to 29.95)
OG00626.2(18.96 to 33.44)
OG00727.4(20.01 to 34.79)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG005
OG006
Cochran-Mantel-Haenszel
0.7908
The multiplicity adjusted p-values are presented.
Difference in rate
4.9
2-Sided
95
-6.26
16.11
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG005
OG007
Cochran-Mantel-Haenszel
0.3170
The multiplicity adjusted p-values are presented.
Difference in rate
5.8
2-Sided
95
-5.43
17.05
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG00924.00(18.77 to 30.06)
OG01035.00(28.99 to 41.58)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0088
The multiplicity adjusted p-values are presented.
Difference in rate
11.3
2-Sided
95
2.70
19.65
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG00912.2(7.71 to 16.69)
OG01023.6(17.90 to 29.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0026
The multiplicity adjusted p-values are presented.
Difference in rate
11.5
2-Sided
95
4.11
18.83
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003176
OG004174
OG00596
OG006143
OG007145
OG0080
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG00320.5(15.16 to 27.01)
OG00421.3(15.84 to 27.93)
OG00520.8(13.91 to 30.00)
OG00623.8(17.54 to 31.38)
OG00723.4(17.29 to 30.97)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG005
OG006
Cochran-Mantel-Haenszel
1
The multiplicity adjusted p-values are presented.
Difference in rate
3.1
2-Sided
95
-8.02
13.45
Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG005
OG007
Cochran-Mantel-Haenszel
0.7908
The multiplicity adjusted p-values are presented.
Difference in rate
2.3
2-Sided
95
-8.78
12.56
Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003176
OG004174
OG00596
OG006143
OG007145
OG0080
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG0039.9(5.43 to 14.42)
OG00412.3(5.43 to 14.42)
OG0058.7(2.84 to 14.52)
OG00610.2(5.15 to 15.27)
OG00715.3(9.33 to 21.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG005
OG006
Cochran-Mantel-Haenszel
1
The multiplicity adjusted p-values are presented.
Difference in rate
1.6
2-Sided
95
-6.51
9.73
Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG005
OG007
Cochran-Mantel-Haenszel
0.5235
The multiplicity adjusted p-values are presented.
Difference in rate
6.5
2-Sided
95
-2.24
15.16
Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG00046
OG00176
OG00287
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Title
Denominators
Categories
CD-PRO/SS Functional Domain Score
Title
Measurements
OG000-0.7± 0.4
OG001-1.4± 0.3
OG002-1.6± 0.3
CD-PRO/SS Bowel Domain Score
Title
Measurements
OG000-0.7± 0.4
OG001-1.5± 0.3
OG002-1.3± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Bowel Domain Score
MMRM
0.3110
Difference in LSM
-0.5
2-Sided
90
-1.4
0.3
Superiority
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG00287
OG003132
OG004137
OG00591
OG006138
OG007137
OG0080
OG0090
OG0100
Title
Denominators
Categories
CD-PRO/SS Functional Domain Score
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003132
ParticipantsOG004137
ParticipantsOG00591
ParticipantsOG006138
ParticipantsOG007137
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG003-2.0± 0.2
OG004-2.3± 0.2
OG005-1.9± 0.3
OG006
CD-PRO/SS Bowel Domain Score
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003132
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG005
OG006
Functional Domain Scale
MMRM
1
The multiplicity adjusted p-values are presented.
Difference in LSM
0.2
2-Sided
95
-0.5
0.9
Superiority
OG005
OG007
Functional Domain Score
MMRM
1
The multiplicity adjusted p-values are presented.
Difference in LSM
-0.0
2-Sided
95
-0.7
0.7
Superiority
OG005
OG006
Bowel Domain Score
MMRM
1
The multiplicity adjusted p-values are presented.
Difference in LSM
0.1
2-Sided
95
-0.8
0.9
Superiority
OG005
OG007
Bowel Domain Score
MMRM
1
The multiplicity adjusted p-values are presented.
Difference in LSM
-0.3
2-Sided
95
-1.1
0.5
Superiority
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00997
OG010108
Title
Denominators
Categories
Title
Measurements
OG00939.2(30.05 to 49.12)
OG01056.5(47.07 to 65.45)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0677
The multiplicity adjusted p-values are presented.
Difference in rate
17.3
2-Sided
95
3.52
30.27
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00991
OG01093
Title
Denominators
Categories
Title
Measurements
OG00911.0(6.08 to 19.06)
OG01029.0(20.79 to 38.94)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0480
The multiplicity adjusted p-values are presented.
Difference in rates
18.6
2-Sided
95
11.07
25.96
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00958
OG01072
Title
Denominators
Categories
Title
Measurements
OG00925.3(14.14 to 36.44)
OG01037.5(26.28 to 48.72)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.1210
Difference in rates
13.5
2-Sided
95
-2.90
29.94
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG0095.9(2.62 to 9.18)
OG01012.1(7.61 to 16.54)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0480
The multiplicity adjusted p-values are presented.
Difference in rates
6.2
2-Sided
95
0.54
11.93
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG00919.8(15.06 to 25.62)
OG01030.9(25.11 to 37.31)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0677
The multiplicity adjusted p-values are presented.
Difference in rates
11.2
2-Sided
95
3.04
19.24
Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00991
OG01093
Title
Denominators
Categories
Title
Measurements
OG0099.9(5.29 to 17.74)
OG01025.8(18.00 to 35.53)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG009
OG010
Cochran-Mantel-Haenszel
0.0035
Nominal p-value, no adjustment for multiplicity performed.
Difference in rates
16.2
2-Sided
95
8.96
23.31
Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.
Superiority
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG002
Induction Phase - Cohort 1 (Exploratory): Placebo
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG007
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG00059
OG001120
OG002121
OG003176
OG004174
OG00596
OG006143
OG007145
OG00853
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG00050
OG00183
OG00282
OG003120
OG004115
OG00551
OG00695
OG00785
OG00842
OG009190
OG010189
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG00059
OG001120
OG002121
OG003176
OG004174
OG00596
OG006143
OG007145
OG00853
OG009217
OG010217
Title
Denominators
Categories
Grade 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0000
OG0010
OG0061
Grade 2
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Grade 3
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Grade 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Grade 5
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm received one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Induction Phase - Cohort 3 (Pivotal): Placebo
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG008
Maintenance Phase - Placebo Responders: Placebo
Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 underwent a sham randomization into the Maintenance Phase. Placebo responders from induction received blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Units
Counts
Participants
OG00059
OG001120
OG002121
OG003176
OG004174
OG00596
OG006143
OG007145
OG00853
OG009217
OG010217
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0092
OG0101
OG002
Etro 105/ Placebo Induction and Maintenance Phase Cohort
Etro 105/ Placebo Induction and Maintenance Phase Cohort
Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy that were re-randomized into the Mainetnance Phase. Etrolizumab responders from induction who re re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64
OG003
Etro 210/ Placebo Induction and Maintenance Phase
Participants who received etrolizumab 210 mg during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy that were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who were re-randomized to this arm received blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64
OG004
Etro 105/Etro 105 Induction and Maintenance Phase
Participants who received etrolizumab 105mg during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy that were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who were re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab 105mg q4w from Week 16 to Week 64
OG005
Etro 210/Etro 105 Induction and Maintenance Phase
Participants who received etrolizumab 210mg during the Induction Phase (from Cohorts 1-3) and achieved CDAI-70 response at Week 14 without the use of rescue therapy that were re-randomized into the Maintenance Phase. Etrolizumab responders from induction who were re-randomized to this arm received blinded maintenance treatment with an SC injection of etrolizumab 105mg q4w from Week 16 to Week 64
Units
Counts
Participants
OG000222
OG001223
OG002108
OG003109
OG004109
OG005108
Title
Denominators
Categories
Baseline with positive ADA
ParticipantsOG000217
ParticipantsOG001218
ParticipantsOG002107
ParticipantsOG003108
ParticipantsOG004107
ParticipantsOG005108
Title
Measurements
OG0004.1
OG0012.8
OG0022.8
OG003
Treatment emergent ADA
ParticipantsOG000213
ParticipantsOG001216
ParticipantsOG002108
ParticipantsOG003109
Cohort 2 Etrolizumab 105mg
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG003
Cohort 2 Etrolizumab 210mg
Cohort 2 enrolled participants after Cohort 1 and was considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm received one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG004
Cohort 3 Etrolizumab 105mg
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
OG005
Cohort 3 Etrolizumab 210mg
Cohort 3 was the last to enroll participants (after Cohort 2) and was the pivotal cohort for the Induction Phase. Participants randomized to this arm received one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants also received one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Participants who received etrolizumab 105 mg during Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response without the use of resceu therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab 105 mg q4w from Week 16 to Week 64
Participants who received etrolizumab 210 mg during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.