A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 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 Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.
Key facts
- Study ID
- NCT07185009
- Run by
- Sanofi
- People needed
- 671
- Starts
- 2026-01-16
- Expected to finish
- 2033-04-28
- Last updated by the study team
- 2026-07-15
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 SUNSCAPE-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 participant's potential participation in a clinical trial.
Where it is running
- Del Sol Research Management, LLC - Site Number: 8400012 — Tucson, Arizona, United States (enrolling)
- Southern California GI & Liver Centers - Site Number: 8400062 — Coronado, California, United States (enrolling)
- United Medical Doctors CA - Site Number: 8400044 — Murrieta, California, United States (enrolling)
- Om Research, LLC - Victorville - Site Number: 8400022 — Victorville, California, United States (enrolling)
- Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs, Colorado, United States (enrolling)
- Royal Palm Clinical Research - Site Number: 8400065 — Fort Myers, Florida, 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)
- Delta Research Partners - Site Number: 8400087 — Monroe, Louisiana, United States (enrolling)
- Gastroenterology Associates of Western Michigan - Site Number: 8400060 — Wyoming, Michigan, United States (enrolling)
- Gateway Gastroenterology - Site Number: 8400097 — Chesterfield, Missouri, United States (enrolling)
- BVL Clinical Research - Site Number: 8400005 — Liberty, Missouri, United States (enrolling)
- MedTraits NY - Site Number: 8400045 — Maspeth, 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)
- 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)
- 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)
Full record on ClinicalTrials.gov
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