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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
751
Start Date
2026-01-16
Completion Date
2033-04-28
Last Updated
2026-10-16
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 (171)
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona, United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, United States
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California, United States
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
Atlanta Gastroenterology Associates-Site Number: 8400109
Atlanta, Georgia, United States
Grand Teton Research Group, PLLC-Site Number: 8400127
Idaho Falls, Idaho, United States
GI Alliance - Gurnee-Site Number:
Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100
New Albany, Indiana, United States
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058
Lexington, Kentucky, 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
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana, United States
UMass Memorial Medical Center-Site Number: 8400121
Worcester, Massachusetts, 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
Premier Health Research, LLC-Site Number: 8400114
Sparta, New Jersey, 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
Lenox Hill Hospital-Site Number: 8400052
New York, 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
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, United States
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
Pittsburgh, Pennsylvania, United States
University Gastroenterology-Site Number: 8400103
Providence, Rhode Island, United States
One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125
Kingwood, Texas, 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
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101
Southlake, 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 : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0360001
South Brisbane, Australia
Investigational Site Number : 0400003
Krems, Lower Austria, Austria
Investigational Site Number : 0400002
Salzburg, Austria
Investigational Site Number : 0560003
Yvoir, Belgium
Investigational Site Number : 1000003
Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgaria
Investigational Site Number : 1000001
Sofia, Bulgaria
Investigational Site Number : 1240003
Toronto, Ontario, Canada
Investigational Site Number : 1240004
Edmonton, Canada
Investigational Site Number : 1240009
Hamilton, Canada
Investigational Site Number : 1240013
London, Canada
Investigational Site Number : 1240006
New Westminster, Canada
Investigational Site Number : 1520004
Santiago, Chile
Investigational Site Number : 1520002
Santiago, Chile
Investigational Site Number : 1520001
Viña del Mar, Chile
Investigational Site Number : 1560002
Guangzhou, Guangdong, China
Investigational Site Number : 1560026
Huizhou, Guangdong, China
Investigational Site Number : 1560018
Wuxi, Jiangsu, China
Investigational Site Number : 1560001
Chengdu, Sichuan, China
Investigational Site Number : 1560027
Beijing, China
Investigational Site Number : 1560028
Hefei, China
Investigational Site Number : 1560052
Kunming, China
Investigational Site Number : 1560020
Shanghai, China
Investigational Site Number : 2030011
Hradec Králové, Czechia
Investigational Site Number : 2500009
Amiens, France
Investigational Site Number : 2500008
Besançon, France
Investigational Site Number : 2500003
Créteil, France
Investigational Site Number : 2500004
La Tronche, France
Investigational Site Number : 2500010
Lille, France
Investigational Site Number : 2500012
Marseille, France
Investigational Site Number : 2500007
Nantes, France
Investigational Site Number : 2500013
Nice, France
Investigational Site Number : 2500001
Paris, France
Investigational Site Number : 2500002
Saint-Priest-en-Jarez, France
Investigational Site Number : 2500011
Toulouse, France
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, France
Investigational Site Number : 2680007
Kutaisi, Georgia
Investigational Site Number : 2680006
Tbilisi, Georgia
Investigational Site Number : 2680008
Tbilisi, Georgia
Investigational Site Number : 2680003
Tbilisi, Georgia
Investigational Site Number : 2680002
Tbilisi, Georgia
Investigational Site Number : 2680005
Tbilisi, Georgia
Investigational Site Number : 2680009
Tbilisi, Georgia
Investigational Site Number : 2760009
Tübingen, Baden-Wurttemberg, Germany
Investigational Site Number : 2760005
Ulm, Baden-Wurttemberg, Germany
Investigational Site Number : 2760015
Leipzig, Saxony, Germany
Investigational Site Number : 2760011
Halle, Saxony-Anhalt, Germany
Investigational Site Number : 2760001
Kiel, Schleswig-Holstein, Germany
Investigational Site Number : 2760003
Berlin, Germany
Investigational Site Number : 2760010
Minden, Germany
Investigational Site Number : 3000002
Athens, Greece
Investigational Site Number : 3480004
Budapest, Hungary
Investigational Site Number : 3480002
Budapest, Hungary
Investigational Site Number : 3480001
Veszprém, Hungary
Investigational Site Number : 3760001
Jerusalem, Israel
Investigational Site Number : 3760002
Tel Aviv, Israel
Investigational Site Number : 3800009
Rome, Italy
Investigational Site Number : 3800003
Rozzano, Italy
Investigational Site Number : 3800005
Turin, Italy
Investigational Site Number : 3920059
Bunkyō City, Japan
Investigational Site Number : 3920039
Chikushino-shi, Japan
Investigational Site Number : 3920031
Hachiōji, Japan
Investigational Site Number : 3920049
Kagoshima, Japan