A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Recruiting now Phase 3 NCT07184944
Run by Sanofi · for 16 to 80 · All sexes
What this study is about
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
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 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 STARSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
🚫 You may not be able to join if…
- 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 patient's potential participation in a clinical trial
Where this trial is running
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039, Colorado Springs, Colorado, United States
- Clinical Research of Osceola-Site Number: 8400013, Kissimmee, Florida, United States
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053, Miami, Florida, United States
- NMC Research LLC-Site Number: 8400033, Tampa, Florida, United States
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100, New Albany, Indiana, United States
- GI Alliance - Baton Rouge-Site Number: 8400129, Baton Rouge, Louisiana, United States
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128, Mandeville, Louisiana, United States
- Gateway Gastroenterology-Site Number: 8400097, St Louis, Missouri, United States
- MedTraits NY-Site Number: 8400045, Maspeth, New York, United States
- NYU Langone Health-Site Number: 8400091, New York, New York, United States
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040, New York, New York, United States
- New York Gastroenterology Associates-Site Number: 8400009, New York, New York, United States
+ 23 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: NCT07184944.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.