Actively Recruiting
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Led by Sanofi · Updated on 2026-04-28
671
Participants Needed
20
Research Sites
379 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
T
Teva Branded Pharmaceutical Products R&D LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.
CONDITIONS
Official Title
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 80 years at baseline, or 16 to less than 18 years if Tanner stage 5
- Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1 for the Pivotal Maintenance Sub-Study
- Participants who complete the Pivotal Maintenance Sub-Study or TV48574-IMM-20038 Study for the Open-Label Extension Sub-Study
You will not qualify if you...
- Participants with medical or compliance conditions deemed unsuitable by the investigator
- Participants with known hypersensitivity to duvakitug deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, United States, 92118
Actively Recruiting
2
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
Royal Palm Clinical Research - Site Number: 8400065
Fort Myers, Florida, United States, 33901
Actively Recruiting
4
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida, United States, 34741
Actively Recruiting
5
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
Miami, Florida, United States, 33155
Actively Recruiting
6
NMC Research LLC - Site Number: 8400033
Tampa, Florida, United States, 33607
Actively Recruiting
7
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
8
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana, United States, 71291
Actively Recruiting
9
BVL Clinical Research - Site Number: 8400005
Liberty, Missouri, United States, 64068
Actively Recruiting
10
New York Gastroenterology Associates - Site Number: 8400009
New York, New York, United States, 10075
Actively Recruiting
11
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
12
Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus, Ohio, United States, 43202
Actively Recruiting
13
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas, United States, 75701
Actively Recruiting
14
Investigational Site Number : 1240003
Toronto, Ontario, Canada, M6A 3B4
Actively Recruiting
15
Tokai University Hachioji Hospital - Site Number : 3920031
Hachiōji, Japan, 192-0032
Actively Recruiting
16
Investigational Site Number : 3920030
Kamakura, Japan, 247-0056
Actively Recruiting
17
Investigational Site Number : 3920019
Kobe, Japan, 650-0015
Actively Recruiting
18
Investigational Site Number : 3920029
Sapporo, Japan, 004-0041
Actively Recruiting
19
Investigational Site Number : 6880001
Belgrade, Serbia, 11,000
Actively Recruiting
20
Investigational Site Number : 6880002
Belgrade, Serbia, 11000
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here