A Study to Evaluate the Efficacy, Safety, and Pharmacokin... | NCT03558152 | Trialant
NCT03558152
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Apr 14, 2023Actual
Enrollment
195Actual
Phase
Phase 2
Conditions
Ulcerative Colitis
Interventions
UTTR1147A
UTTR1147A Placebo
Vedolizumab
Vedolizumab Placebo
Countries
United States
Bulgaria
Georgia
Germany
Greece
Hungary
Ireland
Israel
Italy
Moldova
Poland
Russia
Serbia
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03558152
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GA39925
Secondary IDs
ID
Type
Description
Link
2017-002350-36
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Official Title
A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2023
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
Oct 26, 2018Actual
Primary Completion Date
Dec 15, 2021Actual
Completion Date
Dec 15, 2021Actual
First Submitted Date
Jun 1, 2018
First Submission Date that Met QC Criteria
Jun 13, 2018
First Posted Date
Jun 15, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2022
Results First Submitted that Met QC Criteria
Mar 23, 2023
Results First Posted Date
Apr 14, 2023Actual
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
Mar 23, 2023
Last Update Posted Date
Apr 14, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
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 study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
195Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Experimental
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: Vedolizumab Placebo
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Experimental
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: UTTR1147A Placebo
Drug: Vedolizumab Placebo
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Experimental
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: Vedolizumab Placebo
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Experimental
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: UTTR1147A Placebo
Drug: Vedolizumab Placebo
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
UTTR1147A
Drug
UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Clinical Remission at Week 8
Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
8 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Remission
Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1.
Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of UC
Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
Use of highly effective contraception as defined by the protocol
Exclusion Criteria:
History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
History of cancer as defined by the protocol
Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
Prior treatment with UTTR1147A
Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
Prior treatment with rituximab
Use of prohibited therapies, as defined by the protocol, prior to randomization
Congenital or acquired immune deficiency
Evidence or treatment of infections or history of infections, as defined by the protocol
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Carolina Digestive Diseases
Greenville
North Carolina
27834
United States
University of Utah School of Medicine; Gastroenterology Division
Danese S, Rothenberg ME, Lim JJ, Ding HT, McBride JM, Chen Y, Dash A, Mar JS, Keir M, Peyrin-Biroulet L, Panes J, Colombel JF, Feagan B, Valentine JF, Schreiber S. A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1387-1397. doi: 10.1016/j.cgh.2024.11.013. Epub 2024 Dec 16.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
Patients were assigned in a 1:1:1:1:1:1:2:1 ratio to one of eight treatment arms. Following completion of the screening period and after all patient eligibility requirements were confirmed, patients were assigned a patient number and randomly assigned to a treatment arm through an interactive voice or Web-based response system (IxRS).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
FG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jul 26, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
China
France
Netherlands
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
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: Vedolizumab Placebo
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Experimental
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: UTTR1147A
Drug: UTTR1147A Placebo
Drug: Vedolizumab Placebo
Arm 4: Vedolizumab
Active Comparator
Parts A and B: Vedolizumab and UTTR1147A Placebo.
Drug: UTTR1147A Placebo
Drug: Vedolizumab
Arm 5: Placebo
Placebo Comparator
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: UTTR1147A Placebo
Drug: Vedolizumab Placebo
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Efmarodocokin alfa
RO7021610
RG7880
IL-22Fc
UTTR1147A Placebo
Drug
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Arm 4: Vedolizumab
Arm 5: Placebo
Vedolizumab
Drug
Vedolizumab will be administered IV, as specified in the prescribing information.
Arm 4: Vedolizumab
Entyvio
Vedolizumab Placebo
Drug
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Arm 5: Placebo
At Weeks 8 and 30
Maximum Serum Concentration (Cmax) of UTTR1147A
Days 1 - 29, Visit: Day 57
Minimum Serum Concentration (Cmin) of UTTR1147A
Days 1 - 29, Visit: Day 57
Percentage of Participants With Clinical Response at Week 8
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
NOTE: An Outcome Measure Description has not been entered.
At Week 8
Percentage of Participants With Clinical Response at Week 30
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
At Week 30
Percentage of Participants With Endoscopic Healing at Week 8
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
At Week 8
Percentage of Participants With Endoscopic Healing at Week 30
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
At Week 30
Percentage of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
At Week 8
Percentage of Participants With Endoscopic Remission at Week 30
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
At Week 30
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
At Week 8
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
At Week 30
Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
At Week 8
Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
At Week 30
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
At Week 8
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
At Week 30
Percentage of Participants With Adverse Events
Up to 30 weeks
Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
Baseline up to 30
Salt Lake City
Utah
84132
United States
MHAT Saint Karidad EAD
Plovdiv
4000
Bulgaria
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Późna
61-731
Poland
Endoskopia Sp. z o.o.
Sopot
81-756
Poland
Gastromed Kopon Zmudzinski i
Toru?
87-100
Poland
Centrum Zdrowia MDM
Warsaw
00-635
Poland
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warsaw
00-728
Poland
Przychodnia EuroMediCare
Wroc?aw
50-220
Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroc?aw
50-381
Poland
Melita Medical
Wroc?aw
50-449
Poland
Saint Martyr Elizabeth City Hospital
Saint Petersburg
Sankt-Peterburg
195257
Russia
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
Irkutsk
664033
Russia
Rostov State Medical University; Cardiorheumatology Department
Rostov-on-Don
344022
Russia
North-West State Medical University n.a. I.I. Mechnikov
Saint Petersburg
191015
Russia
Medical University Reaviz
Samara
443011
Russia
Clinical Hospital Center Zvezdara
Belgrade
11000
Serbia
KBC Dr Dragisa Misovic Dedinje
Belgrade
11000
Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade
11080
Serbia
Clinical Center Kragujevac; Clinic Of Psychiatry
Kragujevac
34000
Serbia
General Hospital Vrsac
Vršac
26300
Serbia
Clinical Hospital Centre Zemun
Zemun
11080
Serbia
General Hospital Djordje Joanovic - Zrenjanin
Zrenjanin
23000
Serbia
Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
Las Palmas de Gran Canaria
LAS Palmas
35010
Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz
Madrid
28850
Spain
Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department
Chernivtsi
Chernihiv Governorate
58001
Ukraine
Medical Centre of PE First Private Clinic
Zhytomyr
Crimean Regional Governmenta
10008
Ukraine
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
Ternopil
Katerynoslav Governorate
46002
Ukraine
City Clinical Hospital #1; Department of Gastroenterology
Vinnytsia
Kharkiv Governorate
21029
Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia
Kharkiv Governorate
69600
Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro
KIEV Governorate
49005
Ukraine
Treatment and Diagnostic Center of LLC MRT Elit
Kropyvnytskyi
KIEV Governorate
25005
Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv
KIEV Governorate
01001
Ukraine
Medical Center of Limited Liability Company ?Harmoniya krasy?
Kyiv
KIEV Governorate
01135
Ukraine
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv
KIEV Governorate
02000
Ukraine
Medical Center of Edelweiss Medics LLC
Kyiv
KIEV Governorate
02002
Ukraine
Synexus Affiliate - MC of LLC Medbud-Clinic
Kyiv
KIEV Governorate
03037
Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv
KIEV Governorate
2091
Ukraine
Medical Center of LLC Diaservis
Zaporizhzhia
KIEV Governorate
69076
Ukraine
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Vinnytsia
Podolia Governorate
21029
Ukraine
Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology
Dnipr
Polissya Okruha
49600
Ukraine
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
Uzhhorod
88000
Ukraine
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
Zaporizhzhia
69035
Ukraine
Kings College Hospital
London
SW9 8RR
United Kingdom
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
FG002
Arm: 2A: UTTR1147A 60 + UTTR1147A
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
FG003
Arm: 2B: UTTR1147A 60 + Placebo
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
FG004
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
FG005
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
FG006
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
FG007
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
FG00022 subjects
FG00121 subjects
FG00221 subjects
FG00323 subjects
FG00422 subjects
FG00521 subjects
FG00643 subjects
FG00722 subjects
COMPLETED
FG0007 subjects
FG0016 subjects
FG0028 subjects
FG0038 subjects
FG0043 subjects
FG0057 subjects
FG00621 subjects
FG0076 subjects
NOT COMPLETED
FG00015 subjects
FG00115 subjects
FG00213 subjects
FG00315 subjects
FG00419 subjects
FG00514 subjects
FG00622 subjects
FG00716 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Rolled over in GA40209 due to worsening of disease
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Miscalculation in mmcs
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Mistake in calculation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Mistake in evaluation of disease status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG00011 subjects
FG00111 subjects
FG00210 subjects
FG00311 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
BG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
BG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
BG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
BG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00043
BG00144
BG00243
BG00343
BG00422
BG005195
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00040.6± 13.2
BG00139.4± 12.1
BG00239.5± 12.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
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
Percentage of Participants With Clinical Remission at Week 8
Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Posted
Count of Participants
Participants
8 weeks
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
Units
Counts
Participants
OG00043
OG00144
OG00243
OG003
Title
Denominators
Categories
Yes
Title
Measurements
OG0005
OG0014
OG0025
OG003
Secondary
Percentage of Participants With Sustained Remission
Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1.
Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment
Posted
Number
80% Confidence Interval
Percentage of Participants
At Weeks 8 and 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Secondary
Maximum Serum Concentration (Cmax) of UTTR1147A
Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3
(1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
Posted
Mean
Standard Deviation
ng/mL
Days 1 - 29, Visit: Day 57
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
Units
Counts
Participants
Secondary
Minimum Serum Concentration (Cmin) of UTTR1147A
Due to low enrollment in Part B of the study, the PK data from pooled Arms 1-3
(1A + 1B; 2A + 2B; 3A + 3B) are summarized based on data up through Week 8 which is the primary efficacy assessment for Part A (Induction phase). A total of 130 patients who received at least one dose of efmarodocokin alfa and had measurable PK concentrations are included in the analysis.
Posted
Mean
Standard Deviation
ng/mL
Days 1 - 29, Visit: Day 57
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
Units
Counts
Participants
Secondary
Percentage of Participants With Clinical Response at Week 8
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
NOTE: An Outcome Measure Description has not been entered.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
Secondary
Percentage of Participants With Clinical Response at Week 30
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG003
Secondary
Percentage of Participants With Endoscopic Healing at Week 8
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Percentage of Participants With Endoscopic Healing at Week 30
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG003
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Percentage of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Percentage of Participants With Endoscopic Remission at Week 30
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Posted
Number
80% Confidence Interval
Percentage of Participants
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG003
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Posted
Mean
Standard Deviation
Points on scale
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Secondary
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Number of analyzed participants reflects number of participants who submitted the EC-PRO questionnaire at Week 30.
Posted
Mean
Standard Deviation
Points on scale
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Secondary
Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Posted
Mean
Standard Deviation
Points on scale
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Secondary
Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Number of analyzed participants reflects number of participants who submitted the EC-PRO questionnaire at Week 30.
Posted
Mean
Standard Deviation
Points on scale
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Secondary
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Posted
Mean
Standard Deviation
Points on scale
At Week 8
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Posted
Mean
Standard Deviation
Points on scale
At Week 30
ID
Title
Description
OG000
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG001
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
OG002
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
OG003
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Secondary
Percentage of Participants With Adverse Events
Posted
Count of Participants
Participants
Up to 30 weeks
ID
Title
Description
OG000
Arm 1
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 2
Participants received UTTR1147A at a dose of 60 ug/kg
OG002
Arm 3
Participants received UTTR1147A at a dose of 90 ug/kg
OG003
Arm 4: Vedolizumab
Participants received Vedolizumab and UTTR1147A Placebo
OG004
Arm 5: Placebo
Participants received UTTR1147A Placebo and Vedolizumab Placebo.
Units
Counts
Secondary
Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
Participants in placebo groups were not analyzed for post-baseline Anti-Drug Antibodies (ADA)
Posted
Count of Participants
Participants
No
Baseline up to 30
ID
Title
Description
OG000
Arm 1a
Participants received UTTR1147A at a dose of 30 ug/kg
OG001
Arm 1B
Participants received UTTR1147A at a dose of 30 ug/kg
OG002
Arm 2a
Participants received UTTR1147A at a dose of 60 ug/kg
OG003
Arm 2b
Participants received UTTR1147A at a dose of 60 ug/kg
OG004
Arm 3a
Participants received UTTR1147A at a dose of 90 ug/kg
Time Frame
Baseline up to 30 weeks
Description
Only patients who meet the criteria for clinical response at Week 8 (the end of induction phase, without use of rescue therapy) continued into the maintenance phase.
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
Arm 1: UTTR1147A 30 ug/kg Induction
Combined arms: 1A: UTTR1147A 30 + UTTR1147A and 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
0
7
0
7
2
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected43 at risk
EG0030 events0 affected43 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected7 at risk
Colitis ulcerative
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected44 at risk
EG0024 events4 affected43 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected43 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected43 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0006 events3 affected43 at risk
EG0012 events1 affected44 at risk
EG0020 events0 affected43 at risk
EG0034 events2 affected43 at risk
EG0042 events1 affected22 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected7 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA version 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0010 events0 affected44 at risk
EG0022 events1 affected43 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0012 events1 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events1 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Herpes zoster infection neurological
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0004 events2 affected43 at risk
EG0016 events3 affected44 at risk
EG0022 events1 affected43 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0012 events1 affected44 at risk
EG0022 events1 affected43 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0006 events2 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0008 events3 affected43 at risk
EG0010 events0 affected44 at risk
EG0022 events1 affected43 at risk
EG003
Blood glucose increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0004 events2 affected43 at risk
EG0012 events1 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Blood uric acid increased
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0024 events1 affected43 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0022 events1 affected43 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events1 affected44 at risk
EG0022 events1 affected43 at risk
EG003
Headache
Nervous system disorders
MedDRA version 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0012 events1 affected44 at risk
EG0026 events2 affected43 at risk
EG003
Epididymal cyst
Reproductive system and breast disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0006 events3 affected43 at risk
EG00114 events5 affected44 at risk
EG00228 events9 affected43 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected43 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.