An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT07184931
- Run by
- Sanofi
- People needed
- 980
- Starts
- 2025-10-01
- Expected to finish
- 2029-05-14
- Last updated by the study team
- 2026-07-01
Who can join
Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- M3 Wake Research - Atlanta: 8400028 — Sandy Springs, Georgia, United States (enrolling)
- EBGS Clinical Research Center, LLC-Site Number 8400037 — Snellville, Georgia, United States (enrolling)
- Grand Teton Research Group, PLLC-Site Number: 8400127 — Idaho Falls, Idaho, United States (enrolling)
- Midwest Digestive Health and Nutrition-Site Number: 8400136 — Des Plaines, Illinois, United States (enrolling)
- GI Alliance - Glenview - Site Number: 8400068 — Glenview, Illinois, United States (enrolling)
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049 — Gurnee, Illinois, United States (enrolling)
- Gastroenterology Health Partners, PLLC - Site Number: 8400100 — New Albany, Indiana, United States (enrolling)
- Cedar Valley Digestive Health Center-Site Number: 8400096 — Waterloo, Iowa, United States (enrolling)
- GI Alliance - Baton Rouge - Site Number: 8400129 — Baton Rouge, Louisiana, United States (enrolling)
- Tandem Intermediate, LLC - Houma-Site Number: 8400034 — Houma, Louisiana, United States (enrolling)
- Gastro Group-Site Number: 8400128 — Mandeville, Louisiana, United States (enrolling)
- Tandem Clinical Research - Marrero-Site Number: 8400002 — Marrero, Louisiana, United States (enrolling)
- GI Alliance - Metairie-Site Number: 8400124 — Metairie, Louisiana, United States (enrolling)
- Delta Research Partners-Site Number: 8400087 — Monroe, Louisiana, United States (enrolling)
- Care Access - New Iberia-Site Number: 8400031 — New Iberia, Louisiana, United States (enrolling)
- Mid-Atlantic GI Research, LLC - Site Number: 8400106 — Greenbelt, Maryland, United States (enrolling)
- UMass Memorial Medical Center-Site Number: 8400121 — Worcester, Massachusetts, United States (enrolling)
- Gastroenterology Associates of Western Michigan - Site Number: 8400060 — Wyoming, Michigan, United States (enrolling)
- Allied Health Clinical Research Organization, LLC - Jackson-Site Number: 8400007 — Jackson, Mississippi, United States (enrolling)
- Gateway Gastroenterology: 8400097 — Chesterfield, Missouri, United States (enrolling)
- BVL Clinical Research: 8400005 — Liberty, Missouri, United States (enrolling)
- Las Vegas Clinical Trials- Site Number: 8400079 — Las Vegas, Nevada, United States (enrolling)
- Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123 — East Orange, New Jersey, United States (enrolling)
- Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014 — Freehold, New Jersey, United States (enrolling)
- Atlanta Gastroenterology Associates-Site Number: 8400109 — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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