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RECRUITING Phase 3 ClinicalTrials.gov

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07184996

Registry updated: 2026-08-20
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Description

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.

Interventions

  • Duvakitug (Drug)
    Pharmaceutical form:Solution for Injection-Route of administration:SC injection
  • Placebo (Drug)
    Pharmaceutical form:Solution for injection-Route of administration:SC injection

Eligibility criteria

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development * Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline * Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies Exclusion Criteria: * Participants with Crohn's Disease (CD), indeterminate colitis * Current diagnosis of Ulcerative Proctitis * Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections * Prior or current high-grade gastrointestinal (GI) dysplasia * Participants on treatment with but not on stable doses of conventional therapies prior to baseline * Participants with prohibited medications or therapies prior to baseline * Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Conditions

Ulcerative Colitis

Locations

  • 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
  • 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
  • University of Pennsylvania School of Medicine - Site Number: 8400072 — Philadelphia, Pennsylvania, United States
  • The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107 — Pittsburgh, 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
  • Inquest Clinical Research - Site Number: 8400144 — Baytown, Texas, United States
  • The University of Texas Southwestern Medical Center - Site Number: 8400098 — Dallas, Texas, 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
  • Velocity Clinical Research, Salt Lake City - Site Number: 8400147 — West Jordan, Utah, United States
  • Blue Ridge Medical Research - Site Number: 8400020 — Lynchburg, Virginia, United States
  • Clinical Research Partners - Site Number: 8400080 — Richmond, Virginia, United States
  • GI Alliance - Bellevue - Site Number: 8400143 — Bellevue, Washington, United States
  • The Vancouver Clinic Inc. P.S. - Site Number: 8400090 — Vancouver, Washington, United States
  • Investigational Site Number : 1000007 — Rusa, Bulgaria
  • Investigational Site Number : 1000008 — Sofia, Bulgaria
  • Investigational Site Number : 1000001 — Sofia, Bulgaria
  • 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
  • Investigational Site Number : 1560001 — Chengdu, China
  • Investigational Site Number : 2030011 — Hradec Králové, Czechia
  • Investigational Site Number : 2500010 — Lille, France
  • Investigational Site Number : 2500013 — Nice, 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 : 2680005 — Tbilisi, Georgia
  • Investigational Site Number : 2680003 — Tbilisi, Georgia
  • LLC The First Medical Center - Site Number : 2680004 — Tbilisi, Georgia
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002 — Tbilisi, Georgia
  • Investigational Site Number : 2760003 — Berlin, Germany
  • Investigational Site Number : 2760026 — Herne, Germany
  • Investigational Site Number : 2760001 — Kiel, Germany
  • Investigational Site Number : 2760015 — Leipzig, Germany
  • Investigational Site Number : 2760010 — Minden, Germany
  • Investigational Site Number : 2760005 — Ulm, Germany
  • Investigational Site Number : 3480004 — Budapest, Hungary
  • Asahikawa City Hospital - Site Number : 3920011 — Asahikawa, Japan
  • Investigational Site Number : 3920005 — Asahikawa, Japan
  • The University of Tokyo Hospital - Site Number : 3920059 — Bunkyō City, Japan
  • Investigational Site Number : 3920039 — Chikushino-shi, Japan
  • Investigational Site Number : 3920021 — Chūō, 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
  • Investigational Site Number : 3920008 — Okayama, Japan
  • Investigational Site Number : 3920050 — Osaka, Japan
  • National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002 — Osaka, Japan
  • Public Institution Panevezys Republican hospital - Site Number : 4400002 — Panevezys, Japan
  • Investigational Site Number : 3920014 — Saga, Japan
  • Investigational Site Number : 3920023 — Sakura, Japan
  • Sapporo Tokushukai Hospital - Site Number : 3920019 — Sapporo, Japan
  • Investigational Site Number : 3920056 — 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
  • Investigational Site Number : 3920015 — Toyohashi, Japan
  • Mie University Hospital - Investigational Site Number : 3920009 — Tsu, Japan
  • Investigational Site Number : 3920035 — Yokohama, Japan
  • Investigational Site Number : 4400001 — Kaunas, Lithuania
  • 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
  • Investigational Site Number : 6160013 — Elblag, Poland
  • Investigational Site Number : 6160014 — Katowice, Poland
  • Investigational Site Number : 6160022 — Krakow, Poland
  • Investigational Site Number : 6160016 — Lodz, Poland
  • Investigational Site Number : 6160018 — Poznan, Poland
  • Investigational Site Number : 6160025 — Rzeszów, Poland
  • Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004 — Sopot, Poland
  • New health-CK, Kieltucki and partners g.p. - Site Number : 6160007 — Staszów, Poland
  • Investigational Site Number : 6160002 — Szczecin, Poland
  • SONOMED - Site Number : 6160020 — Szczecin, Poland
  • Investigational Site Number : 6160012 — Wadowice, Poland
  • Investigational Site Number : 6160005 — Warsaw, Poland
  • Investigational Site Number : 6160006 — Warsaw, Poland
  • Investigational Site Number : 6160031 — Warsaw, Poland
  • Investigational Site Number : 6160028 — Wrocklaw, Poland
  • Puerto Rico Health and Wellness Institute - Site Number: 8400104 — Dorado, Puerto Rico
  • 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 : 6880004 — Niš, Serbia
  • Investigational Site Number : 7030001 — Bratislava, Slovakia
  • Investigational Site Number : 7100005 — Claremont, South Africa
  • Investigational Site Number : 7100004 — Durban, South Africa
  • Investigational Site Number : 7100001 — Kempton Park, South Africa
  • Investigational Site Number : 7560001 — Bern, Switzerland
  • Investigational Site Number : 1580003 — Chiayi City, Taiwan
  • 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
  • Investigational Site Number : 8040013 — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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