An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

What this study is about

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

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 Crohn's Disease (CD) for at least 3 months prior to baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

🚫 You may not be able to join if…

• Participants with Ulcerative Colitis (UC) or indeterminate colitis
• Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
• Prior or current high-grade gastrointestinal (GI) dysplasia
• Participants on treatment with but not on stable doses of conventional therapy prior to baseline
• Participants receiving prohibited medications or therapies
• 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: 8400018, Little Rock, Arkansas, United States
• Kagoshima IBD Gastroenterology Clinic - 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.: 8400030, Los Angeles, California, United States
• United Medical Doctors CA-Site Number: 8400044, Murrieta, California, United States
• Prospective Research Innovations Inc.: 8400017, Rancho Cucamonga, California, United States
• UC Davis Health System-Site Number: 8400071, Sacramento, California, United States
• Clinical Applications Laboratories Inc-Site Number: 8400056, San Diego, California, United States

+ 289 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: NCT07184931.