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 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT07184944

Run by

Sanofi

People needed

751

Starts

2026-01-22

Expected to finish

2034-03-20

Last updated by the study team

2026-06-22

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 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 qualify 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 it is running

• Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado, United States (enrolling)
• Clinical Research of Osceola-Site Number: 8400013 — Kissimmee, Florida, United States (enrolling)
• Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami, Florida, United States (enrolling)
• NMC Research LLC-Site Number: 8400033 — Tampa, Florida, United States (enrolling)
• Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany, Indiana, United States (enrolling)
• GI Alliance - Baton Rouge-Site Number: 8400129 — Baton Rouge, Louisiana, United States (enrolling)
• Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 — Mandeville, Louisiana, United States (enrolling)
• Gateway Gastroenterology-Site Number: 8400097 — St Louis, Missouri, United States (enrolling)
• MedTraits NY-Site Number: 8400045 — Maspeth, New York, United States (enrolling)
• NYU Langone Health-Site Number: 8400091 — New York, New York, United States (enrolling)
• Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 — New York, New York, United States (enrolling)
• New York Gastroenterology Associates-Site Number: 8400009 — New York, New York, United States (enrolling)
• UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 — Chapel Hill, North Carolina, United States (enrolling)
• Cross Creek Medical Clinic-Site Number: 8400057 — Fayetteville, North Carolina, United States (enrolling)
• Ohio Gastroenterology Group Inc.-Site Number: 8400006 — Columbus, Ohio, United States (enrolling)
• OSU Wexner Medical Center-Site Number: 8400077 — Columbus, Ohio, United States (enrolling)
• North Shore Gastroenterology Research-Site Number: 8400130 — Westlake, Ohio, United States (enrolling)
• University of Pennsylvania School of Medicine-Site Number: 8400072 — Philadelphia, Pennsylvania, United States (enrolling)
• GI Alliance - Lubbock-Site Number: 8400092 — Lubbock, Texas, United States (enrolling)
• Gastroenterology Research of San Antonio LLC-Site Number: 8400054 — San Antonio, Texas, United States (enrolling)
• Tyler Research Institute LLC-Site Number: 8400095 — Tyler, Texas, United States (enrolling)
• Gastroenterology Associates of Western Michigan-Site Number: 8400060 — Wyoming, Wyoming, United States (enrolling)
• Investigational Site Number : 1240009 — Hamilton, Canada (enrolling)
• Investigational Site Number : 1240003 — Toronto, Canada (enrolling)
• Investigational Site Number : 2680008 — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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