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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
2026-03-30
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 (140)
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
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
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California, United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, 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
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
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
Bio Research Partner - Site Number: 8400053
Miami, Florida, United States
Medical Professional Clinical Research Center - Site Number: 8400119
Miami, Florida, United States
Correa Research Center-Site Number: 8400010
Miami, Florida, United States
Orlando Health, Inc. - Site Number: 8400084
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
Grand Teton Research Group, PLLC - Site Number: 8400127
Idaho Falls, Idaho, 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
Cedar Valley Digestive Health Center - Site Number: 8400096
Waterloo, Iowa, 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
Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt, Maryland, 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
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
New York Gastroenterology Associates - Site Number: 8400009
New York, 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
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
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, United States
Central Sooner Research - Site Number: 8400094
Norman, Oklahoma, United States
University of Pennsylvania School of Medicine - Site Number: 8400072
Philadelphia, Pennsylvania, United States
University Gastroenterology - GI Alliance - Site Number: 8400103
Providence, Rhode Island, United States
Biocentric Health Research Partner
West Columbia, South Carolina, United States
Valley Institute of Research - Site Number: 8400004
Harlingen, Texas, United States
One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
Kingwood, Texas, United States
Innovare Research Group - Site Number: 8400067
Lake Jackson, Texas, United States
Texas Digestive Disease Consultants dba 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 - Site Number: 8400101
Southlake, Texas, United States
Texas Gastro Consultants - Site Number: 8400029
Tomball, Texas, United States
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas, United States
Blue Ridge Medical Research - Site Number: 8400020
Lynchburg, Virginia, United States
Clinical Research Partners - Site Number: 8400080
Richmond, Virginia, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington, United States
Charlton Digestive Disease Centre - Site Number : 1240009
Hamilton, Canada
Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
Oakville, Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
Toronto, Canada
LLC The First Medical Center - Site Number : 2680004
Tbilisi, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
Tbilisi, Georgia
Asahikawa City Hospital - Site Number : 3920011
Asahikawa, Japan
The University of Tokyo Hospital - Site Number : 3920059
Bunkyō City, Japan
Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
Fukuoka, Japan
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
Kagoshima, Japan
Ofuna Chuo Hospital - Site Number : 3920029
Kamakura, Japan
National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
Kanazawa, Japan
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
Kashiwa, Japan
Aoyama Clinic, Site Number : 3920018
Kobe, Japan
Hattori Clinic - Site Number : 3920051
Kumamoto, Japan
Nagaoka Red Cross Hospital - Site Number : 3920041
Nagaoka, Japan
National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
Osaka, Japan
Public Institution Panevezys Republican hospital - Site Number : 4400002
Panevezys, Japan
Sapporo Tokushukai Hospital - Site Number : 3920019
Sapporo, Japan
Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
Sapporo, Japan
Takagi Clinic - Site Number : 3920004
Sendai, Japan
National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
Sendai, Japan
National Center for Global Health and Medicine - Site Number : 3920038
Shinjuku, Japan
Iwate Medical University Hospital - Site Number : 3920020
Shiwa-gun, Japan
Tokai University Hachioji Hospital - Site Number : 3920030
Tokyo, Japan
Toyama University Hospital - Site Number : 3920032
Toyama, Japan
Toyama Prefectural Central Hospital - Site Number : 3920037
Toyama, Japan
Mie University Hospital - Investigational Site Number : 3920009
Tsu, Japan
Investigational Site Number : 4980003
Chisinau, Moldova
PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
Chisinau, Moldova
'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
Chisinau, Moldova
Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
Sopot, Poland
New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
Staszów, Poland
SONOMED - Site Number : 6160020
Szczecin, Poland
Wellness Clinical Research - Vega Baja - Site Number: 8400099
Vega Baja, Puerto Rico
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
Belgrade, Serbia
Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
Belgrade, Serbia
University Clinical Center of Serbia - Site Number : 6880006
Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
Belgrade, Serbia
Investigational Site Number : 7560001
Bern, Switzerland
National Taiwan University Hospital - Site Number : 1580002
Taipei, Taiwan
Bukovinian State Medical University - Site Number : 8040003
Chernivtsi, Ukraine
Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
Kyiv, Ukraine
Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
Kyiv, Ukraine
University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
Lviv, Ukraine
State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
Lviv, Ukraine
Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
Lviv, Ukraine
Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
Uzhhorod, Ukraine
Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
Vinnytsia, Ukraine
National Pirogov Memorial Medical University - Site Number : 8040009
Vinnytsia, Ukraine
National Pirogov Memorial Medical University - Site Number : 8040008
Vinnytsia, Ukraine