A Study to Assess the Efficacy and Safety of Risankizumab... | NCT03104413 | Trialant
NCT03104413
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jun 14, 2022Actual
Enrollment
618Actual
Phase
Phase 3
Conditions
Crohn's Disease
Interventions
placebo for risankizumab IV
risankizumab SC
risankizumab IV
Countries
United States
Argentina
Australia
Austria
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czechia
Denmark
Egypt
Estonia
France
Germany
Greece
Ireland
Israel
Italy
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Poland
Portugal
Romania
Russia
Serbia
Singapore
Slovakia
South Africa
South Korea
Spain
Switzerland
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03104413
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M15-991
Secondary IDs
ID
Type
Description
Link
2016-003190-17
EudraCT Number
Brief Title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03914261No longer available
Start Date
Dec 18, 2017Actual
Primary Completion Date
Nov 30, 2020Actual
Completion Date
May 19, 2021Actual
First Submitted Date
Apr 4, 2017
First Submission Date that Met QC Criteria
Apr 4, 2017
First Posted Date
Apr 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2022
Results First Submitted that Met QC Criteria
May 19, 2022
Results First Posted Date
Jun 14, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 16, 2021
Certification/Extension First Submitted that Passed QC Review
May 19, 2022
Certification/Extension First Posted Date
Jun 14, 2022Actual
Last Update Submitted Date
May 19, 2022
Last Update Posted Date
Jun 14, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Detailed Description
Not provided
Conditions Module
Conditions
Crohn's Disease
Keywords
ABBV-066
BI 655066
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
618Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Risankizumab Dose 1 (Induction Period 1)
Experimental
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Drug: risankizumab IV
Risankizumab Dose 2 (Induction Period 1)
Experimental
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
Drug: risankizumab IV
Placebo (Induction Period 1)
Placebo Comparator
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Drug: placebo for risankizumab IV
Risankizumab Dose 1 (Induction Period 2)
Experimental
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Drug: risankizumab IV
Risankizumab Dose 2 (Induction Period 2)
Experimental
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
placebo for risankizumab IV
Drug
placebo for risankizumab administered as intravenous (IV) infusion.
Placebo (Induction Period 1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 12
US Specific: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Week 12
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 12
Global Outside of US: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
US Specific: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 12
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
Demonstrated intolerance or inadequate response to biologic therapy for CD.
If female, participant must meet the contraception recommendations.
Exclusion Criteria:
Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participants with unstable doses of concomitant Crohn's disease therapy.
Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
Prior exposure to p19 inhibitors (e.g., risankizumab).
Complications of Crohn's disease.
Having an ostomy or ileoanal pouch.
Known active Coronavirus Disease 2019 (COVID-19) infection.
Feagan BG, Colombel JF, Panaccione R, Schreiber S, Ferrante M, Kamikozuru K, Ma C, Lee WJ, Griffith J, Joshi N, Kligys K, Kalabic J, Xuan S, Dubinsky M. Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease. Gastro Hep Adv. 2024 Sep 5;4(1):100544. doi: 10.1016/j.gastha.2024.08.022. eCollection 2025.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
For details on when studies are available for sharing, please refer to the link below.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
A total of 618 subjects were enrolled and 605 were included in the intent-to-treat (ITT) population; 569 of those had a baseline eligible Simple Endoscopic Score for Crohn's disease (SES-CD) of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component and were included in the ITT1A population. This population was the primary population for both the United States (US) specific as well as the Global (Outside the US) efficacy analysis' of the 12-Week Induction Period.
Recruitment Details
Subjects were randomized to receive 600mg risankizumab, 1200mg risankizumab or placebo during the double-blind, placebo-controlled Period 1. At Week 12, subjects who do not achieve clinical response were randomized into Period 2 to receive 180mg risankizumab, 360mg risankizumab or 1200mg risankizumab. Subjects who received placebo received 1200mg.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
FG001
Risankizumab 600mg (Induction Period 1)
Periods
Title
Milestones
Reasons Not Completed
Induction Period 1
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
Aug 27, 2020
Mar 30, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
American Samoa
Brazil
Hungary
Turkey (Türkiye)
Submission Tracking
Estimated Results First Submitted Date
Not provided
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
Drug: risankizumab SC
Risankizumab Dose 3 (Induction period 2)
Experimental
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
risankizumab SC
Drug
risankizumab administered by subcutaneous (SC) injection
Risankizumab Dose 2 (Induction Period 2)
Risankizumab Dose 3 (Induction period 2)
ABBV-066 BI 655066
SKYRIZI
risankizumab IV
Drug
risankizumab administered as intravenous (IV) infusion.
Risankizumab Dose 1 (Induction Period 1)
Risankizumab Dose 1 (Induction Period 2)
Risankizumab Dose 2 (Induction Period 1)
ABBV-066 BI 655066
SKYRIZI
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 4
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 12
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Week 12
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 4
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Week 12
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
Week 12
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
Week 12
US Specific: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 4
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 12
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Week 12
US Specific: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Up to Week 12
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 4
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 4
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 12
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Week 12
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Week 12
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 4
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 12
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Week 12
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Week 12
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Week 12
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Week 12
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Week 12
Scottsdale
Arizona
85258
United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938
Chertsey
Surrey
KT16 0PZ
United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202772
Barnsley
S75 2EP
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 157577
Birmingham
B15 2TH
United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 158037
Cambridge
CB2 0QQ
United Kingdom
NHS Lothian /ID# 207446
Edinburgh
EH3 9HE
United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 158759
Hull
HU3 2JZ
United Kingdom
King's College Hospital NHS Foundation Trusts /ID# 158758
London
SE5 9RS
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889
Newcastle upon Tyne
NE7 7DN
United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 158039
Oxford
OX3 9DU
United Kingdom
Duplicate_Northern Care Alliance NHS Group /ID# 207765
Salford
M6 8HD
United Kingdom
Derived
Atreya R, Ferrante M, Panaccione R, Feagan B, Shchukina O, Jairath V, Rieder F, Hisamatsu T, Siegmund B, Kligys K, Song A, Zambrano J, Mallick M, Zhang Y, Armuzzi A, D'Haens G. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies. J Crohns Colitis. 2025 Apr 4;19(4):jjae164. doi: 10.1093/ecco-jcc/jjae164.
Peyrin-Biroulet L, Colombel JF, Louis E, Ferrante M, Motoya S, Panaccione R, Torres J, Ungaro RC, Kligys K, Kalabic J, Zambrano J, Zhang Y, D'Haens G. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies. Gastro Hep Adv. 2024 Mar 7;3(4):539-550. doi: 10.1016/j.gastha.2024.02.008. eCollection 2024.
Schreiber S, Cross RK, Panaccione R, D'Haens G, Bossuyt P, Dotan I, Colombel JF, Louis E, Dubinsky MC, Kligys K, Neimark E, Song A, Zambrano J, Kalabic J, Cheng E, Zhang Y, Ferrante M. Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease. Aliment Pharmacol Ther. 2024 Oct;60(7):897-906. doi: 10.1111/apt.18184. Epub 2024 Jul 25.
Dubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
FG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
FG003
Risankizumab Dose 180mg (Induction Period 2)
Participants randomized to receive risankizumab 180mg by subcutaneous(SC) injection at Weeks 12 and 20.
risankizumab SC: risankizumab administered by subcutaneous (SC) injection.
FG004
Risankizumab 360mg (Induction Period 2)
Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
risankizumab SC: risankizumab administered by subcutaneous (SC) injection
FG005
Risankizumab 1200mg (Induction Period 2)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
FG006
Placebo/Risankizumab 1200mg (Induction Period 2)
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
FG000207 subjects
FG001206 subjects
FG002205 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000186 subjects
FG001202 subjects
FG002199 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00021 subjects
FG0014 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Induction Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00341 subjects
FG00442 subjects
FG00542 subjects
FG00686 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00339 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
The safety population (SA) consists of all subjects who received at least 1 dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
BG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
BG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000207
BG001206
BG002205
BG003618
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0003
BG0011
BG0021
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00039.4± 13.28
BG00140.4± 13.54
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000104
BG001106
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Units
Counts
Participants
OG000187
OG001191
OG002191
Title
Denominators
Categories
Title
Measurements
OG00019.8(14.1 to 25.5)
OG00142.0(34.9 to 49.0)
OG00240.3(33.4 to 47.3)
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
OG001
Cochran-Mantel-Haenszel
<0.001
Adjusted Risk Difference
22.1
2-Sided
95
13.1
31.0
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
< 0.001
Primary
US Specific: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Primary
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Secondary
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Up to Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Secondary
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Secondary
Global Outside of US: Percentage of Participants With Clinical Remission
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Secondary
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Secondary
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Mean
95% Confidence Interval
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Secondary
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Participants with at least one admission to the hospital due to Crohn's Disease.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Secondary
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
Primary
Global Outside of US: Percentage of Participants With Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
OG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
OG002
Risankizumab 1200mg (Induction Period 1)
Time Frame
From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
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 (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
0
207
26
207
51
207
EG001
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
0
206
10
206
32
206
EG002
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
2
205
9
205
32
205
EG003
Period 1 Risankizumab Total
Total Period 1 participants randomized into the Risankizumab treatment arm
2
411
19
411
64
411
EG004
Risankizumab Dose 180mg (Induction Period 2)
Participants randomized to receive risankizumab 180mg by subcutaneous (SC) injection at Weeks 12 and 20.
0
41
2
41
5
41
EG005
Risankizumab 360mg (Induction Period 2)
Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
0
42
2
42
3
42
EG006
Risankizumab 1200mg (Induction Period 2)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
1
42
3
42
8
42
EG007
Placebo/Risankizumab 1200mg (Induction Period 2)
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
0
86
9
86
12
86
EG008
Period 2 Risankizumab Total
Total Period 2 participants randomized into the Risankizumab treatment arm
1
211
16
211
28
211
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0012 events2 affected206 at risk
EG0022 events2 affected205 at risk
EG0034 events4 affected411 at risk
EG0040 events0 affected41 at risk
EG0050 events0 affected42 at risk
EG0060 events0 affected42 at risk
EG0071 events1 affected86 at risk
EG0081 events1 affected211 at risk
BONE MARROW FAILURE
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
MYELOSUPPRESSION
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ATRIAL FLUTTER
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANAL FISTULA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANAL SPHINCTER ATONY
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANAL STENOSIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANORECTAL DISORDER
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
CROHN'S DISEASE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00022 events20 affected207 at risk
EG0011 events1 affected206 at risk
EG0021 events1 affected205 at risk
EG003
DYSBIOSIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ILEAL STENOSIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ILEUS PARALYTIC
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
JEJUNAL STENOSIS
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
PYREXIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ABDOMINAL ABSCESS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
BRONCHOPULMONARY ASPERGILLOSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
CYTOMEGALOVIRUS INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
GASTROENTERITIS ESCHERICHIA COLI
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
NEUTROPENIC SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
PERIRECTAL ABSCESS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
PNEUMONIA STAPHYLOCOCCAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
VIRAL MYOCARDITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
VIRAL PHARYNGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ANASTOMOTIC LEAK
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
CACHEXIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0011 events1 affected206 at risk
EG0020 events0 affected205 at risk
EG003
SQUAMOUS CELL CARCINOMA OF LUNG
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
ABORTION SPONTANEOUS
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
CALCULUS URINARY
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected207 at risk
EG0010 events0 affected206 at risk
EG0020 events0 affected205 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
INCISIONAL HERNIA REPAIR
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
LERICHE SYNDROME
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected207 at risk
EG0010 events0 affected206 at risk
EG0021 events1 affected205 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG00012 events11 affected207 at risk
EG0013 events3 affected206 at risk
EG0024 events4 affected205 at risk
EG0037 events7 affected411 at risk
EG0040 events0 affected41 at risk
EG0050 events0 affected42 at risk
EG0060 events0 affected42 at risk
EG0073 events2 affected86 at risk
EG0083 events2 affected211 at risk
CROHN'S DISEASE
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00013 events13 affected207 at risk
EG0017 events7 affected206 at risk
EG0023 events3 affected205 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00010 events10 affected207 at risk
EG0016 events5 affected206 at risk
EG0024 events3 affected205 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00012 events11 affected207 at risk
EG0018 events8 affected206 at risk
EG0028 events8 affected205 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0008 events8 affected207 at risk
EG0018 events8 affected206 at risk
EG00210 events9 affected205 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00012 events11 affected207 at risk
EG00114 events11 affected206 at risk
EG00211 events10 affected205 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
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.