Recruiting

Phase 3

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

Sponsor:

Sanofi

Code:

NCT07184996

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Duvakitug

Placebo

Study Details

Brief 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.

Conditions

Ulcerative Colitis

Study ID

NCT07184996

Start date

Oct 8, 2025

Status verified date

Aug, 2026

Completion date

May 9, 2028

Anticipated

Primary completion date

May 9, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

980 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Duvakitug - dose 1

Subcutaneous (SC) injection as per protocol

experimental: Duvakitug - dose 2

SC injection as per protocol

placebo comparator: Placebo

SC injection as per protocol

Interventions

Duvakitug

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Primary outcome measure

Proportion of participants achieving clinical remission. [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 contact-us@sanofi.com

Locations

Onyx Clinical Research - Site Number: 8400021

Recruiting

Peoria, Arizona, United States, 85381

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

Recruiting

Scottsdale, Arizona, United States, 85258

Scottsdale Clinical Trials - Site Number: 8400145

Recruiting

Scottsdale, Arizona, United States, 85260

Del Sol Research Management, LLC - Site Number: 8400012

Recruiting

Tucson, Arizona, United States, 85715

Preferred Research Partners - Site Number: 8400018

Recruiting

Little Rock, Arkansas, United States, 72211

FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027

Recruiting

Arcadia, California, United States, 91006

Alliance Research Institute - Site Number: 8400008

Recruiting

Canoga Park, California, United States, 91304

Southern California GI & Liver Centers - Site Number: 8400062

Recruiting

Coronado, California, United States, 92118-1408

GMC Clinical Research, LLC - Site Number: 8400113

Recruiting

Folsom, California, United States, 95630

Om Research, LLC - Lancaster - Site Number: 8400148

Recruiting

Lancaster, California, United States, 93534

TLC Clinical Research Inc. - Site Number: 8400030

Recruiting

Los Angeles, California, United States, 90048

United Medical Doctors CA - Site Number: 8400044

Recruiting

Murrieta, California, United States, 92563

Om Research, LLC - Oxnard - Site Number: 8400150

Recruiting

Oxnard, California, United States, 93030

UC Davis Health System - Site Number: 8400071

Recruiting

Sacramento, California, United States, 95817

Clinical Applications Laboratories Inc - Site Number: 8400056

Recruiting

San Diego, California, United States, 92103

Medical Associates Research Group - Site Number: 8400063

Recruiting

San Diego, California, United States, 92123

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

Recruiting

Santa Maria, California, United States, 93458

Valiance Clinical Research - Tarzana - Site Number: 8400023

Recruiting

Tarzana, California, United States, 91356

Clinical Trials Management Services - Site Number: 8400047

Recruiting

Thousand Oaks, California, United States, 91360

Amicis Research Center-Valencia -Site Number: 8400064

Recruiting

Valencia, California, United States, 91355

Om Research, LLC - Victorville - Site Number: 8400022

Recruiting

Victorville, California, United States, 92395

UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085

Recruiting

Aurora, Colorado, United States, 80045

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Recruiting

Colorado Springs, Colorado, United States, 80907

Gastroenterology of the Rockies - Denver - Site Number: 8400122

Recruiting

Denver, Colorado, United States, 80218

Yale University Digestive Disease - Site Number: 8400108

Recruiting

New Haven, Connecticut, United States, 06510

Novum Research, LLC - Site Number: 8400003

Recruiting

Clermont, Florida, United States, 32803

Precision Clinical Research-Site Number: 8400059

Recruiting

Coral Springs, Florida, United States, 33065

Sarkis Clinical Trials-Ocala - Site Number: 8400048

Recruiting

Gainesville, Florida, United States, 32607

Clinical Research of Osceola - Site Number: 8400013

Recruiting

Kissimmee, Florida, United States, 34741

Columbus Clinical Services LLc - Site Number: 8400038

Recruiting

Miami, Florida, United States, 33125

Regis Clinical Research, LLC - Site Number: 8400041

Recruiting

Miami, Florida, United States, 33126

Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami - Site Number: 8400111

Recruiting

Miami, Florida, United States, 33136

Bio Research Partner - Site Number: 8400053

Recruiting

Miami, Florida, United States, 33155

Medical Professional Clinical Research Center - Site Number: 8400119

Recruiting

Miami, Florida, United States, 33165

Paradisus Med Research - Site Number: 8400036

Recruiting

Miami, Florida, United States, 33185

Correa Research Center-Site Number: 8400010

Recruiting

Miami, Florida, United States, 33186

Orlando Health, Inc. - Site Number: 8400084

Recruiting

Orlando, Florida, United States, 32806

AdventHealth Orlando - Site Number: 8400070

Recruiting

Orlando, Florida, United States, 90067

Tropical Clinical Trials - Site Number: 8400082

Recruiting

Palmetto Bay, Florida, United States, 33176

NMC Research LLC - Site Number: 8400033

Recruiting

Tampa, Florida, United States, 33607

Atlanta Gastroenterology Associates - Site Number: 8400109

Recruiting

Atlanta, Georgia, United States, 30342

M3 Wake Research - Atlanta - Site Number: 8400028

Recruiting

Sandy Springs, Georgia, United States, 30328

EBGS Clinical Research Center, LLC - Site Number: 8400037

Recruiting

Snellville, Georgia, United States, 30078

Atlanta Gastroenterology Specialists - Site Number: 8400149

Recruiting

Suwanee, Georgia, United States, 30024

Grand Teton Research Group, PLLC - Site Number: 8400127

Recruiting

Idaho Falls, Idaho, United States, 83404

Rush University Medical Center - Site Number: 8400015

Recruiting

Chicago, Illinois, United States, 60612

Midwest Digestive Health and Nutrition - Site Number: 8400136

Recruiting

Des Plaines, Illinois, United States, 60016

GI Alliance - Glenview - Site Number: 8400068

Recruiting

Glenview, Illinois, United States, 60026

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

Recruiting

Gurnee, Illinois, United States, 60031

Gastroenterology Health Partners, PLLC - Site Number: 8400100

Recruiting

New Albany, Indiana, United States, 47150

Iowa Digestive Disease Center - Site Number: 8400134

Recruiting

Clive, Iowa, United States, 50325

Cedar Valley Digestive Health Center - Site Number: 8400096

Recruiting

Waterloo, Iowa, United States, 50701

University of Kansas Medical Center - Site Number: 8400110

Recruiting

Kansas City, Kansas, United States, 66160

University of Kentucky Hospital/UK Albert B. Chandler Hospital - Site Number: 8400058

Recruiting

Lexington, Kentucky, United States, 40536-0293

GI Alliance - Baton Rouge - Site Number: 8400129

Recruiting

Baton Rouge, Louisiana, United States, 70809

Tandem Intermediate, LLC - Houma -Site Number: 8400034

Recruiting

Houma, Louisiana, United States, 70072

GastroGroup - Site Number: 8400128

Recruiting

Mandeville, Louisiana, United States, 70471

Tandem Clinical Research - Marrero - Site Number: 8400002

Recruiting

Marrero, Louisiana, United States, 70072

GI Alliance - Metairie - Site Number: 8400124

Recruiting

Metairie, Louisiana, United States, 70006

Delta Research Partners

Recruiting

Monroe, Louisiana, United States, 71291

Care Access - New Iberia - Site Number: 8400031

Recruiting

New Iberia, Louisiana, United States, 70560

Mercy Medical Center, Baltimore - Site Number: 8400117

Recruiting

Baltimore, Maryland, United States, 21202

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

Recruiting

Greenbelt, Maryland, United States, 20770

UMass Memorial Medical Center - Site Number: 8400121

Recruiting

Worcester, Massachusetts, United States, 01655

Gastroenterology Associates of Western Michigan - Site Number: 8400060

Recruiting

Wyoming, Michigan, United States, 49519

Gateway Gastroenterology - Site Number: 8400097

Recruiting

Chesterfield, Missouri, United States, 63017

BVL Clinical Research - Site Number: 8400005

Recruiting

Liberty, Missouri, United States, 64068

Las Vegas Clinical Trials - Site Number: 8400079

Recruiting

Las Vegas, Nevada, United States, 89128

SMS Clinical Research - Site Number: 8400035

Recruiting

Mesquite, Nevada, United States, 75043

Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123

Recruiting

East Orange, New Jersey, United States, 07018

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

Recruiting

Freehold, New Jersey, United States, 07728

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

Recruiting

Jackson, New Jersey, United States, 08527

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

Recruiting

Somers Point, New Jersey, United States, 08244

Premier Health Research, LLC - Site Number: 8400114

Recruiting

Sparta, New Jersey, United States, 07871

MedTraits NY - Site Number: 8400045

Recruiting

Maspeth, New York, United States, 11378

Manhattan Clinical Research, LLC - Site Number: 8400069

Recruiting

New York, New York, United States, 10016

NYU Langone Health - Site Number: 8400091

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10065

Lenox Hill Hospital - Site Number: 8400052

Recruiting

New York, New York, United States, 10075

New York Gastroenterology Associates - Site Number: 8400009

Recruiting

New York, New York, United States, 10075

Montefiore Medical Center - Bronx - Site Number. 8400142

Recruiting

The Bronx, New York, United States, 10467

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

Recruiting

Chapel Hill, North Carolina, United States, 27514

OnSite Clinical Solutions - Site Number: 8400051

Recruiting

Charlotte, North Carolina, United States, 28211

Duke University Medical Center - Site Number: 8400093

Recruiting

Durham, North Carolina, United States, 27710

Cross Creek Medical Clinic - Site Number: 8400057

Recruiting

Fayetteville, North Carolina, United States, 28304

Monroe Biomedical Research - Site Number: 8400046

Recruiting

Monroe, North Carolina, United States, 28112

ClinTrial Research, LLC - Site Number: 8400043

Recruiting

Raleigh, North Carolina, United States, 27612

Plains Medical Clinic - Site Number: 8400078

Recruiting

Fargo, North Dakota, United States, 58104

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

Recruiting

Canton, Ohio, United States, 44718

Ohio Gastroenterology Group Inc. - Site Number: 8400006

Recruiting

Columbus, Ohio, United States, 43202

OSU Wexner Medical Center - Site Number: 8400077

Recruiting

Columbus, Ohio, United States, 43210

DSI Research, LLC - Site Number: 8400115

Recruiting

Dayton, Ohio, United States, 45414

DSI Research, LLC - Site Number: 8400105

Recruiting

Springboro, Ohio, United States, 45066

University of Toledo Medical Center - Site Number: 8400042

Recruiting

Toledo, Ohio, United States, 43614

North Shore Gastroenterology Research - Site Number: 8400130

Recruiting

Westlake, Ohio, United States, 44145

Central Sooner Research - Site Number: 8400094

Recruiting

Norman, Oklahoma, United States, 73071

Oregon Health & Science University, Center for Health and Healing 2 - Site Number: 8400131

Recruiting

Portland, Oregon, United States, 97239-3098

Penn State Milton S. Hershey Medical Center - Site Number: 8400066

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

University of Pennsylvania School of Medicine - Site Number: 8400072

Recruiting

Philadelphia, Pennsylvania, United States, 19104-6243

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

University Gastroenterology - GI Alliance - Site Number: 8400103

Recruiting

Providence, Rhode Island, United States, 02904

Biocentric Health Research Partner

Recruiting

West Columbia, South Carolina, United States, 29169

Inquest Clinical Research - Site Number: 8400144

Recruiting

Baytown, Texas, United States, 77521

The University of Texas Southwestern Medical Center - Site Number: 8400098

Recruiting

Dallas, Texas, United States, 75390

Valley Institute of Research - Site Number: 8400004

Recruiting

Harlingen, Texas, United States, 78550

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

Recruiting

Kingwood, Texas, United States, 77339

Innovare Research Group - Site Number: 8400067

Recruiting

Lake Jackson, Texas, United States, 77566

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

Recruiting

Lubbock, Texas, United States, 79410

Gastroenterology Research of San Antonio LLC - Site Number: 8400054

Recruiting

San Antonio, Texas, United States, 78229

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

Recruiting

Southlake, Texas, United States, 76092

Texas Gastro Consultants - Site Number: 8400029

Recruiting

Tomball, Texas, United States, 77375

Tyler Research Institute, LLC - Site Number: 8400095

Recruiting

Tyler, Texas, United States, 75701

Velocity Clinical Research, Salt Lake City - Site Number: 8400147

Recruiting

West Jordan, Utah, United States, 84088

Blue Ridge Medical Research - Site Number: 8400020

Recruiting

Lynchburg, Virginia, United States, 24502

Clinical Research Partners - Site Number: 8400080

Recruiting

Richmond, Virginia, United States, 23226

GI Alliance - Bellevue - Site Number: 8400143

Recruiting

Bellevue, Washington, United States, 98004

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

Recruiting

Vancouver, Washington, United States, 98664

Charlton Digestive Disease Centre - Site Number : 1240009

Recruiting

Hamilton, Canada, L8N 1Y2

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

Recruiting

Oakville, Canada, L6L 5L7

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

Recruiting

Toronto, Canada, M6A 3B4

More Information

Sponsor

Sanofi

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-20.