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NCT07184996PHASE3Recruiting

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

Sanofi

Start Date

10/8/2025

Completion Date

5/9/2028

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.

Eligibility Criteria

Age Range: 16 years to 80 years

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.

Interventions

DRUG

Duvakitug

DRUG

Placebo

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Conditions

Ulcerative Colitis

Locations

Onyx Clinical Research - Site Number: 8400021

Peoria, Arizona 85381

United States

One of a Kind Clinical Research Center LLC - Site Number: 8400061

Scottsdale, Arizona 85258

United States

Del Sol Research Management, LLC - Site Number: 8400012

Tucson, Arizona 85715

United States

Preferred Research Partners - Site Number: 8400018

Little Rock, Arkansas 72211

United States

FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027

Arcadia, California 91006

United States

Alliance Research Institute - Site Number: 8400008

Canoga Park, California 91304

United States

Southern California GI & Liver Centers - Site Number: 8400062

Coronado, California 92118-1408

United States

GMC Clinical Research, LLC - Site Number: 8400113

Folsom, California 95630

United States

TLC Clinical Research Inc. - Site Number: 8400030

Los Angeles, California 90048

United States

United Medical Doctors CA - Site Number: 8400044

Murrieta, California 92563

United States

Medical Associates Research Group - Site Number: 8400063

San Diego, California 92123

United States

Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025

Santa Maria, California 93458

United States

Valiance Clinical Research - Tarzana - Site Number: 8400023

Tarzana, California 91356

United States

Clinical Trials Management Services - Site Number: 8400047

Thousand Oaks, California 91360

United States

Amicis Research Center-Valencia -Site Number: 8400064

Valencia, California 91355

United States

Om Research, LLC - Victorville - Site Number: 8400022

Victorville, California 92395

United States

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Colorado Springs, Colorado 80907

United States

Gastroenterology of the Rockies - Denver - Site Number: 8400122

Denver, Colorado 80218

United States

Novum Research, LLC - Site Number: 8400003

Clermont, Florida 32803

United States

Precision Clinical Research-Site Number: 8400059

Coral Springs, Florida 33065

United States

Sarkis Clinical Trials-Ocala - Site Number: 8400048

Gainesville, Florida 32607

United States

Clinical Research of Osceola - Site Number: 8400013

Kissimmee, Florida 34741

United States

Columbus Clinical Services LLc - Site Number: 8400038

Miami, Florida 33125

United States

Regis Clinical Research, LLC - Site Number: 8400041

Miami, Florida 33126

United States

Bio Research Partner - Site Number: 8400053

Miami, Florida 33155

United States

Medical Professional Clinical Research Center - Site Number: 8400119

Miami, Florida 33165

United States

Correa Research Center-Site Number: 8400010

Miami, Florida 33186

United States

Orlando Health, Inc. - Site Number: 8400084

Orlando, Florida 32806

United States

Tropical Clinical Trials - Site Number: 8400082

Palmetto Bay, Florida 33176

United States

NMC Research LLC - Site Number: 8400033

Tampa, Florida 33607

United States

Atlanta Gastroenterology Associates - Site Number: 8400109

Atlanta, Georgia 30342

United States

M3 Wake Research - Atlanta - Site Number: 8400028

Sandy Springs, Georgia 30328

United States

EBGS Clinical Research Center, LLC - Site Number: 8400037

Snellville, Georgia 30078

United States

Grand Teton Research Group, PLLC - Site Number: 8400127

Idaho Falls, Idaho 83404

United States

Midwest Digestive Health and Nutrition - Site Number: 8400136

Des Plaines, Illinois 60016

United States

GI Alliance - Glenview - Site Number: 8400068

Glenview, Illinois 60026

United States

Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049

Gurnee, Illinois 60031

United States

Gastroenterology Health Partners, PLLC - Site Number: 8400100

New Albany, Indiana 47150

United States

Cedar Valley Digestive Health Center - Site Number: 8400096

Waterloo, Iowa 50701

United States

GI Alliance - Baton Rouge - Site Number: 8400129

Baton Rouge, Louisiana 70809

United States

Tandem Intermediate, LLC - Houma -Site Number: 8400034

Houma, Louisiana 70072

United States

GastroGroup - Site Number: 8400128

Mandeville, Louisiana 70471

United States

Tandem Clinical Research - Marrero - Site Number: 8400002

Marrero, Louisiana 70072

United States

GI Alliance - Metairie - Site Number: 8400124

Metairie, Louisiana 70006

United States

Delta Research Partners

Monroe, Louisiana 71291

United States

Care Access - New Iberia - Site Number: 8400031

New Iberia, Louisiana 70560

United States

Mid-Atlantic GI Research, LLC - Site Number: 8400106

Greenbelt, Maryland 20770

United States

UMass Memorial Medical Center - Site Number: 8400121

Worcester, Massachusetts 01655

United States

Gastroenterology Associates of Western Michigan - Site Number: 8400060

Wyoming, Michigan 49519

United States

Gateway Gastroenterology - Site Number: 8400097

Chesterfield, Missouri 63017

United States

BVL Clinical Research - Site Number: 8400005

Liberty, Missouri 64068

United States

Las Vegas Clinical Trials - Site Number: 8400079

Las Vegas, Nevada 89128

United States

SMS Clinical Research - Site Number: 8400035

Mesquite, Nevada 75043

United States

Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123

East Orange, New Jersey 07018

United States

Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014

Freehold, New Jersey 07728

United States

Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007

Jackson, New Jersey 08527

United States

Tandem-Allied Clinical Research - Somers Point - Site Number: 840050

Somers Point, New Jersey 08244

United States

Premier Health Research, LLC - Site Number: 8400114

Sparta, New Jersey 07871

United States

MedTraits NY - Site Number: 8400045

Maspeth, New York 11378

United States

Manhattan Clinical Research, LLC - Site Number: 8400069

New York, New York 10016

United States

NYU Langone Health - Site Number: 8400091

New York, New York 10016

United States

Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040

New York, New York 10065

United States

New York Gastroenterology Associates - Site Number: 8400009

New York, New York 10075

United States

UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074

Chapel Hill, North Carolina 27514

United States

OnSite Clinical Solutions - Site Number: 8400051

Charlotte, North Carolina 28211

United States

Cross Creek Medical Clinic - Site Number: 8400057

Fayetteville, North Carolina 28304

United States

Monroe Biomedical Research - Site Number: 8400046

Monroe, North Carolina 28112

United States

ClinTrial Research, LLC - Site Number: 8400043

Raleigh, North Carolina 27612

United States

Plains Medical Clinic - Site Number: 8400078

Fargo, North Dakota 58104

United States

Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139

Canton, Ohio 44718

United States

Ohio Gastroenterology Group Inc. - Site Number: 8400006

Columbus, Ohio 43202

United States

OSU Wexner Medical Center - Site Number: 8400077

Columbus, Ohio 43210

United States

DSI Research, LLC - Site Number: 8400115

Dayton, Ohio 45414

United States

DSI Research, LLC - Site Number: 8400105

Springboro, Ohio 45066

United States

North Shore Gastroenterology Research - Site Number: 8400130

Westlake, Ohio 44145

United States

Central Sooner Research - Site Number: 8400094

Norman, Oklahoma 73071

United States

University of Pennsylvania School of Medicine - Site Number: 8400072

Philadelphia, Pennsylvania 19104-6243

United States

The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107

Pittsburgh, Pennsylvania 15212

United States

University Gastroenterology - GI Alliance - Site Number: 8400103

Providence, Rhode Island 02904

United States

Biocentric Health Research Partner

West Columbia, South Carolina 29169

United States

Valley Institute of Research - Site Number: 8400004

Harlingen, Texas 78550

United States

One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125

Kingwood, Texas 77339

United States

Innovare Research Group - Site Number: 8400067

Lake Jackson, Texas 77566

United States

Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092

Lubbock, Texas 79410

United States

Gastroenterology Research of San Antonio LLC - Site Number: 8400054

San Antonio, Texas 78229

United States

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101

Southlake, Texas 76092

United States

Texas Gastro Consultants - Site Number: 8400029

Tomball, Texas 77375

United States

Tyler Research Institute, LLC - Site Number: 8400095

Tyler, Texas 75701

United States

Blue Ridge Medical Research - Site Number: 8400020

Lynchburg, Virginia 24502

United States

Clinical Research Partners - Site Number: 8400080

Richmond, Virginia 23226

United States

The Vancouver Clinic Inc. P.S. - Site Number: 8400090

Vancouver, Washington 98664

United States

Investigational Site Number : 1000007

Rusa, 7002

Bulgaria

Investigational Site Number : 1000008

Sofia, 1343

Bulgaria

Investigational Site Number : 1000001

Sofia, 1618

Bulgaria

Charlton Digestive Disease Centre - Site Number : 1240009

Hamilton, L8N 1Y2

Canada

Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010

Oakville, L6L 5L7

Canada

Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003

Toronto, M6A 3B4

Canada

Investigational Site Number : 1560001

Chengdu, 610065

China

Investigational Site Number : 2030011

Hradec Králové, 500 12

Czechia

Investigational Site Number : 2500010

Lille, 59000

France

Investigational Site Number : 2500013

Nice, 6200

France

Investigational Site Number : 2500006

Vandœuvre-lès-Nancy, 54511

France

Investigational Site Number : 2680007

Kutaisi, 4600

Georgia

Investigational Site Number : 2680006

Tbilisi, 102

Georgia

Investigational Site Number : 2680008

Tbilisi, 144

Georgia

Investigational Site Number : 2680005

Tbilisi, 160

Georgia

Investigational Site Number : 2680003

Tbilisi, 180

Georgia

LLC The First Medical Center - Site Number : 2680004

Tbilisi, 180

Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002

Tbilisi, 180

Georgia

Investigational Site Number : 2760003

Berlin, 14163

Germany

Investigational Site Number : 2760026

Herne, 44623

Germany

Investigational Site Number : 2760001

Kiel, 24105

Germany

Investigational Site Number : 2760015

Leipzig, 4103

Germany

Investigational Site Number : 2760010

Minden, 32423

Germany

Investigational Site Number : 2760005

Ulm, 89081

Germany

Investigational Site Number : 3480004

Budapest, 1066

Hungary

Asahikawa City Hospital - Site Number : 3920011

Asahikawa, 070-8610

Japan

Investigational Site Number : 3920005

Asahikawa, 078-8510

Japan

The University of Tokyo Hospital - Site Number : 3920059

Bunkyō City, 113-8655

Japan

Investigational Site Number : 3920039

Chikushino-shi, 818-8502

Japan

Investigational Site Number : 3920021

Chūō, 104-0061

Japan

Japanese Red Cross Fukuoka Hospital - Site Number : 3920027

Fukuoka, 815-8555

Japan

Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049

Kagoshima, 892-0843

Japan

Ofuna Chuo Hospital - Site Number : 3920029

Kamakura, 247-0056

Japan

National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010

Kanazawa, 920-8650

Japan

Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031

Kashiwa, 277-0871

Japan

Aoyama Clinic, Site Number : 3920018

Kobe, 650-0015

Japan

Hattori Clinic - Site Number : 3920051

Kumamoto, 860-0004

Japan

Nagaoka Red Cross Hospital - Site Number : 3920041

Nagaoka, 940-2085

Japan

Investigational Site Number : 3920008

Okayama, 703-8511

Japan

Investigational Site Number : 3920050

Osaka, 532-0003

Japan

National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002

Osaka,

Japan

Public Institution Panevezys Republican hospital - Site Number : 4400002

Panevezys, 35144

Japan

Investigational Site Number : 3920014

Saga, 849-8501

Japan

Investigational Site Number : 3920023

Sakura, 285-8741

Japan

Sapporo Tokushukai Hospital - Site Number : 3920019

Sapporo, 004-0041

Japan

Investigational Site Number : 3920056

Sapporo, 062-8618

Japan

Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042

Sapporo, 065-0033

Japan

Takagi Clinic - Site Number : 3920004

Sendai, 981-3213

Japan

National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003

Sendai,

Japan

National Center for Global Health and Medicine - Site Number : 3920038

Shinjuku, 162-8655

Japan

Iwate Medical University Hospital - Site Number : 3920020

Shiwa-gun, 028-3695

Japan

Tokai University Hachioji Hospital - Site Number : 3920030

Tokyo, 192-0032

Japan

Toyama University Hospital - Site Number : 3920032

Toyama, 930-0194

Japan

Toyama Prefectural Central Hospital - Site Number : 3920037

Toyama, 930-8550

Japan

Investigational Site Number : 3920015

Toyohashi, 441-8570

Japan

Mie University Hospital - Investigational Site Number : 3920009

Tsu, 514-8507

Japan

Investigational Site Number : 3920035

Yokohama, 232-0024

Japan

Investigational Site Number : 4400001

Kaunas, LT-50161

Lithuania

Investigational Site Number : 4980003

Chisinau, MD-2025

Moldova

PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002

Chisinau, MD-2025

Moldova

'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004

Chisinau, MD-2068

Moldova

Investigational Site Number : 6160013

Elblag, 82-300

Poland

Investigational Site Number : 6160014

Katowice, 40-748

Poland

Investigational Site Number : 6160022

Krakow, 31-506

Poland

Investigational Site Number : 6160016

Lodz, 90-752

Poland

Investigational Site Number : 6160018

Poznan, 60-309

Poland

Investigational Site Number : 6160025

Rzeszów, 35-055

Poland

Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004

Sopot, 81-756

Poland

New health-CK, Kieltucki and partners g.p. - Site Number : 6160007

Staszów, 28-200

Poland

Investigational Site Number : 6160002

Szczecin, 71-434

Poland

SONOMED - Site Number : 6160020

Szczecin, 71-685

Poland

Investigational Site Number : 6160012

Wadowice, 34-100

Poland

Investigational Site Number : 6160005

Warsaw, 00-189

Poland

Investigational Site Number : 6160006

Warsaw, 00-189

Poland

Investigational Site Number : 6160031

Warsaw, 01-595

Poland

Investigational Site Number : 6160028

Wrocklaw, 53-611

Poland

Wellness Clinical Research - Vega Baja - Site Number: 8400099

Vega Baja, 00693

Puerto Rico

Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001

Belgrade, 11,000

Serbia

Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007

Belgrade, 11000

Serbia

University Clinical Center of Serbia - Site Number : 6880006

Belgrade, 11000

Serbia

Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002

Belgrade, 11080

Serbia

Investigational Site Number : 6880004

Niš, 18000

Serbia

Investigational Site Number : 7030001

Bratislava, 811 09

Slovakia

Investigational Site Number : 7100005

Claremont, 7708

South Africa

Investigational Site Number : 7100004

Durban, 3610

South Africa

Investigational Site Number : 7100001

Kempton Park, 1619

South Africa

Investigational Site Number : 7560001

Bern, 3012

Switzerland

Investigational Site Number : 1580003

Chiayi City, 60002

Taiwan

National Taiwan University Hospital - Site Number : 1580002

Taipei, 100226

Taiwan

Bukovinian State Medical University - Site Number : 8040003

Chernivtsi, 58001

Ukraine

Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001

Kyiv, 2002

Ukraine

Investigational Site Number : 8040013

Kyiv, 2091

Ukraine

Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002

Kyiv, 3037

Ukraine

University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004

Lviv, 79000

Ukraine

State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012

Lviv, 79010

Ukraine

Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005

Lviv, 79019

Ukraine

Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006

Uzhhorod, 88000

Ukraine

Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010

Vinnytsia, 21013

Ukraine

National Pirogov Memorial Medical University - Site Number : 8040009

Vinnytsia, 21028

Ukraine

National Pirogov Memorial Medical University - Site Number : 8040008

Vinnytsia, 21029

Ukraine