TrialPath
← Back to searchRecruiting

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

NCT07185009 · Sanofi
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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: 2026-04-03
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 (10)
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
GI Alliance - Baton Rouge - Site Number: 8400129Recruiting
Baton Rouge, Louisiana, United States
Delta Research Partners - Site Number: 8400087Recruiting
Monroe, Louisiana, United States
BVL Clinical Research - Site Number: 8400005Recruiting
Liberty, Missouri, United States
New York Gastroenterology Associates - Site Number: 8400009Recruiting
New York, New York, United States
Ohio Gastroenterology Group Inc. - Site Number: 8400006Recruiting
Columbus, Ohio, United States
Tyler Research Institute, LLC - Site Number: 8400095Recruiting
Tyler, Texas, United States
Tokai University Hachioji Hospital - Site Number : 3920031Recruiting
Hachiōji, Japan
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis · TrialPath