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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Sanofi
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. 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.
Official title: A Multicenter, Multinational, 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
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
671
Start Date
2026-01-16
Completion Date
2033-04-28
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Duvakitug
Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo
Pharmaceutical form:Injection solution-Route of administration:SC injection
Locations (30)
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, Colorado, United States
Royal Palm Clinical Research - Site Number: 8400065
Fort Myers, Florida, 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
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana, United States
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming, Michigan, United States
Gateway Gastroenterology - Site Number: 8400097
Chesterfield, Missouri, United States
BVL Clinical Research - Site Number: 8400005
Liberty, Missouri, United States
MedTraits NY - Site Number: 8400045
Maspeth, New York, United States
New York Gastroenterology Associates - Site Number: 8400009
New York, New York, United States
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina, United States
Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus, Ohio, United States
OSU Wexner Medical Center - Site Number: 8400077
Columbus, Ohio, United States
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, United States
GI Alliance - Lubbock - Site Number: 8400092
Lubbock, Texas, United States
Gastroenterology Research of San Antonio LLC - Site Number: 8400054
San Antonio, Texas, United States
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington, United States
Investigational Site Number : 1240003
Toronto, Ontario, Canada
Tokai University Hachioji Hospital - Site Number : 3920031
Hachiōji, Japan
Investigational Site Number : 3920049
Kagoshima, Japan
Investigational Site Number : 3920030
Kamakura, Japan
Investigational Site Number : 3920019
Kobe, Japan
Investigational Site Number : 3920029
Sapporo, Japan
Investigational Site Number : 6880001
Belgrade, Serbia
Investigational Site Number : 6880002
Belgrade, Serbia
Investigational Site Number : 8040006
Uzhhorod, Ukraine