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

What this study is about

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Who can join (things the study team will check)

✅ You may be able to join if…

• Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
• Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

🚫 You may not be able to join if…

• Participants with Crohn's Disease (CD), indeterminate colitis
• Current diagnosis of Ulcerative Proctitis
• Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
• Prior or current high-grade gastrointestinal (GI) dysplasia
• Participants on treatment with but not on stable doses of conventional therapies prior to baseline
• Participants with prohibited medications or therapies prior to baseline
• Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where this trial is running

• Onyx Clinical Research - Site Number: 8400021, Peoria, Arizona, United States
• One of a Kind Clinical Research Center LLC - Site Number: 8400061, Scottsdale, Arizona, United States
• Del Sol Research Management, LLC - Site Number: 8400012, Tucson, Arizona, United States
• Preferred Research Partners - Site Number: 8400018, Little Rock, Arkansas, United States
• FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027, Arcadia, California, United States
• Alliance Research Institute - Site Number: 8400008, Canoga Park, California, United States
• Southern California GI & Liver Centers - Site Number: 8400062, Coronado, California, United States
• GMC Clinical Research, LLC - Site Number: 8400113, Folsom, California, United States
• TLC Clinical Research Inc. - Site Number: 8400030, Los Angeles, California, United States
• United Medical Doctors CA - Site Number: 8400044, Murrieta, California, United States
• Medical Associates Research Group - Site Number: 8400063, San Diego, California, United States
• Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025, Santa Maria, California, United States

+ 179 more sites.

Who to contact

Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07184996.