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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07185009 · Sanofi
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Official title
A Multicenter, Multinational, 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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development) * Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1 * OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study Exclusion Criteria: * Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator * Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study design
Enrollment target: 671 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2033-04-28
Last updated: 2026-05-22
Interventions
Drug: DuvakitugDrug: Placebo
Primary outcomes
  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). (Week 40)
Sponsor
Sanofi · industry
With: Teva Branded Pharmaceutical Products R&D LLC
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (30)
Southern California GI & Liver Centers - Site Number: 8400062Recruiting
Coronado, California, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039Recruiting
Colorado Springs, Colorado, United States
Royal Palm Clinical Research - Site Number: 8400065Recruiting
Fort Myers, Florida, United States
Clinical Research of Osceola - Site Number: 8400013Recruiting
Kissimmee, Florida, United States
Bioresearch Partner-Kendale Lakes - Site Number: 8400053Recruiting
Miami, Florida, United States
NMC Research LLC - Site Number: 8400033Recruiting
Tampa, Florida, United States
GI Alliance - Baton Rouge - Site Number: 8400129Recruiting
Baton Rouge, Louisiana, United States
Delta Research Partners - Site Number: 8400087Recruiting
Monroe, Louisiana, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060Recruiting
Wyoming, Michigan, United States
Gateway Gastroenterology - Site Number: 8400097Recruiting
Chesterfield, Missouri, United States
BVL Clinical Research - Site Number: 8400005Recruiting
Liberty, Missouri, United States
MedTraits NY - Site Number: 8400045Recruiting
Maspeth, New York, United States
New York Gastroenterology Associates - Site Number: 8400009Recruiting
New York, New York, United States
Cross Creek Medical Clinic - Site Number: 8400057Recruiting
Fayetteville, North Carolina, United States
Ohio Gastroenterology Group Inc. - Site Number: 8400006Recruiting
Columbus, Ohio, United States
OSU Wexner Medical Center - Site Number: 8400077Recruiting
Columbus, Ohio, United States
North Shore Gastroenterology Research - Site Number: 8400130Recruiting
Westlake, Ohio, United States
GI Alliance - Lubbock - Site Number: 8400092Recruiting
Lubbock, Texas, United States
Gastroenterology Research of San Antonio LLC - Site Number: 8400054Recruiting
San Antonio, Texas, United States
Tyler Research Institute, LLC - Site Number: 8400095Recruiting
Tyler, Texas, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090Recruiting
Vancouver, Washington, United States
Investigational Site Number : 1240003Recruiting
Toronto, Ontario, Canada
Tokai University Hachioji Hospital - Site Number : 3920031Recruiting
Hachiōji, Japan
Investigational Site Number : 3920049Recruiting
Kagoshima, Japan
Investigational Site Number : 3920030Recruiting
Kamakura, Japan
Investigational Site Number : 3920019Recruiting
Kobe, Japan
Investigational Site Number : 3920029Recruiting
Sapporo, Japan
Investigational Site Number : 6880001Recruiting
Belgrade, Serbia
Investigational Site Number : 6880002Recruiting
Belgrade, Serbia
Investigational Site Number : 8040006Recruiting
Uzhhorod, Ukraine
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis · TrialPath