A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
NCT07185009
This study is recruiting at 28 US sites in 13 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Ulcerative Colitis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Sanofi
- Last updated on ClinicalTrials.gov
- September 15, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Del Sol Research Management, LLC - Site Number: 8400012 · Tucson, AZ
California · 3
- Southern California GI & Liver Centers - Site Number: 8400062 · Coronado, CA
- United Medical Doctors CA - Site Number: 8400044 · Murrieta, CA
- Om Research, LLC - Victorville - Site Number: 8400022 · Victorville, CA
Colorado · 1
- Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 · Colorado Springs, CO
Florida · 4
- Royal Palm Clinical Research - Site Number: 8400065 · Fort Myers, FL
- Clinical Research of Osceola - Site Number: 8400013 · Kissimmee, FL
- Bioresearch Partner-Kendale Lakes - Site Number: 8400053 · Miami, FL
- NMC Research LLC - Site Number: 8400033 · Tampa, FL
Indiana · 1
- Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100 · New Albany, IN
Louisiana · 3
- GI Alliance - Baton Rouge - Site Number: 8400129 · Baton Rouge, LA
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128 · Mandeville, LA
- Delta Research Partners - Site Number: 8400087 · Monroe, LA
Michigan · 1
- Gastroenterology Associates of Western Michigan - Site Number: 8400060 · Wyoming, MI
Missouri · 2
- Gateway Gastroenterology - Site Number: 8400097 · Chesterfield, MO
- BVL Clinical Research - Site Number: 8400005 · Liberty, MO
New York · 3
- MedTraits NY - Site Number: 8400045 · Maspeth, NY
- New York Gastroenterology Associates - Site Number: 8400009 · New York, NY
- Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040 · New York, NY
North Carolina · 1
- Cross Creek Medical Clinic - Site Number: 8400057 · Fayetteville, NC
Ohio · 3
- Ohio Gastroenterology Group Inc. - Site Number: 8400006 · Columbus, OH
- OSU Wexner Medical Center - Site Number: 8400077 · Columbus, OH
- North Shore Gastroenterology Research - Site Number: 8400130 · Westlake, OH
Texas · 4
- GI Alliance - Lubbock - Site Number: 8400092 · Lubbock, TX
- Gastroenterology Research of San Antonio LLC - Site Number: 8400054 · San Antonio, TX
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101 · Southlake, TX
- Tyler Research Institute, LLC - Site Number: 8400095 · Tyler, TX
Washington · 1
- The Vancouver Clinic Inc. P.S. - Site Number: 8400090 · Vancouver, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.