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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Sanofi
Summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
Official title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction 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
980
Start Date
2025-10-08
Completion Date
2028-05-09
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Duvakitug
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Locations (240)
Onyx Clinical Research - Site Number: 8400021
Peoria, Arizona, United States
One of a Kind Clinical Research Center LLC - Site Number: 8400061
Scottsdale, Arizona, United States
Scottsdale Clinical Trials - Site Number: 8400145
Scottsdale, Arizona, United States
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona, United States
Preferred Research Partners - Site Number: 8400018
Little Rock, Arkansas, United States
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California, United States
Alliance Research Institute - Site Number: 8400008
Canoga Park, California, United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, United States
GMC Clinical Research, LLC - Site Number: 8400113
Folsom, California, United States
Om Research, LLC - Lancaster - Site Number: 8400148
Lancaster, California, United States
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California, United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, United States
Om Research, LLC - Oxnard - Site Number: 8400150
Oxnard, California, United States
UC Davis Health System - Site Number: 8400071
Sacramento, California, United States
Clinical Applications Laboratories Inc - Site Number: 8400056
San Diego, California, United States
Medical Associates Research Group - Site Number: 8400063
San Diego, California, United States
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria, California, United States
Valiance Clinical Research - Tarzana - Site Number: 8400023
Tarzana, California, United States
Clinical Trials Management Services - Site Number: 8400047
Thousand Oaks, California, United States
Amicis Research Center-Valencia -Site Number: 8400064
Valencia, California, United States
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California, United States
UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085
Aurora, Colorado, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, Colorado, United States
Gastroenterology of the Rockies - Denver - Site Number: 8400122
Denver, Colorado, United States
Yale University Digestive Disease - Site Number: 8400108
New Haven, Connecticut, United States
Novum Research, LLC - Site Number: 8400003
Clermont, Florida, United States
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida, United States
Sarkis Clinical Trials-Ocala - Site Number: 8400048
Gainesville, Florida, United States
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida, United States
Columbus Clinical Services LLc - Site Number: 8400038
Miami, Florida, United States
Regis Clinical Research, LLC - Site Number: 8400041
Miami, Florida, United States
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami - Site Number: 8400111
Miami, Florida, United States
Bio Research Partner - Site Number: 8400053
Miami, Florida, United States
Medical Professional Clinical Research Center - Site Number: 8400119
Miami, Florida, United States
Paradisus Med Research - Site Number: 8400036
Miami, Florida, United States
Correa Research Center-Site Number: 8400010
Miami, Florida, United States
Orlando Health, Inc. - Site Number: 8400084
Orlando, Florida, United States
AdventHealth Orlando - Site Number: 8400070
Orlando, Florida, United States
Tropical Clinical Trials - Site Number: 8400082
Palmetto Bay, Florida, United States
NMC Research LLC - Site Number: 8400033
Tampa, Florida, United States
Atlanta Gastroenterology Associates - Site Number: 8400109
Atlanta, Georgia, United States
M3 Wake Research - Atlanta - Site Number: 8400028
Sandy Springs, Georgia, United States
EBGS Clinical Research Center, LLC - Site Number: 8400037
Snellville, Georgia, United States
Atlanta Gastroenterology Specialists - Site Number: 8400149
Suwanee, Georgia, United States
Grand Teton Research Group, PLLC - Site Number: 8400127
Idaho Falls, Idaho, United States
Rush University Medical Center - Site Number: 8400015
Chicago, Illinois, United States
Midwest Digestive Health and Nutrition - Site Number: 8400136
Des Plaines, Illinois, United States
GI Alliance - Glenview - Site Number: 8400068
Glenview, Illinois, United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany, Indiana, United States
Iowa Digestive Disease Center - Site Number: 8400134
Clive, Iowa, United States
Cedar Valley Digestive Health Center - Site Number: 8400096
Waterloo, Iowa, United States
University of Kansas Medical Center - Site Number: 8400110
Kansas City, Kansas, 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
Tandem Intermediate, LLC - Houma -Site Number: 8400034
Houma, Louisiana, United States
GastroGroup - Site Number: 8400128
Mandeville, Louisiana, United States
Tandem Clinical Research - Marrero - Site Number: 8400002
Marrero, Louisiana, United States
GI Alliance - Metairie - Site Number: 8400124
Metairie, Louisiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Care Access - New Iberia - Site Number: 8400031
New Iberia, Louisiana, United States
Mercy Medical Center, Baltimore - Site Number: 8400117
Baltimore, Maryland, United States
Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt, Maryland, United States
Tufts Medical Center - Site Number: 8400126
Boston, Massachusetts, 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
Las Vegas Clinical Trials - Site Number: 8400079
Las Vegas, Nevada, United States
SMS Clinical Research - Site Number: 8400035
Mesquite, Nevada, United States
Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
East Orange, New Jersey, United States
Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
Freehold, New Jersey, United States
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
Jackson, New Jersey, United States
Atlantic Health System, Morristown Medical Center-Site Number: 400137
Morristown, New Jersey, United States
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
Somers Point, New Jersey, United States
Premier Health Research, LLC - Site Number: 8400114
Sparta, New Jersey, United States
MedTraits NY - Site Number: 8400045
Maspeth, New York, United States
Manhattan Clinical Research, LLC - Site Number: 8400069
New York, New York, United States
NYU Langone Health - Site Number: 8400091
New York, New York, United States
Weill Cornell Medical College - 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
Montefiore Medical Center - Bronx - Site Number. 8400142
The Bronx, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074
Chapel Hill, North Carolina, United States
OnSite Clinical Solutions - Site Number: 8400051
Charlotte, North Carolina, United States
Duke University Medical Center - Site Number: 8400093
Durham, North Carolina, United States
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina, United States
Monroe Biomedical Research - Site Number: 8400046
Monroe, North Carolina, United States
ClinTrial Research, LLC - Site Number: 8400043
Raleigh, North Carolina, United States
Plains Medical Clinic - Site Number: 8400078
Fargo, North Dakota, United States
Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
Canton, Ohio, United States
Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus, Ohio, United States
OSU Wexner Medical Center - Site Number: 8400077
Columbus, Ohio, United States
DSI Research, LLC - Site Number: 8400115
Dayton, Ohio, United States
DSI Research, LLC - Site Number: 8400105
Springboro, Ohio, United States
University of Toledo Medical Center - Site Number: 8400042
Toledo, Ohio, United States
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, United States
Central Sooner Research - Site Number: 8400094
Norman, Oklahoma, United States
Oregon Health & Science University, Center for Health and Healing 2 - Site Number: 8400131
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center - Site Number: 8400066
Hershey, Pennsylvania, United States