Recruiting

Phase 3

DuvakitugAn Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Sponsor:

Sanofi

Code:

NCT07184931

Conditions

Crohn's Disease

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, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:

The study duration may be up to 35 weeks with:

Up to 5-week 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).
6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.

The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Conditions

Crohn's Disease

Study ID

NCT07184931

Start date

Oct 1, 2025

Status verified date

Jun, 2026

Completion date

May 14, 2029

Anticipated

Primary completion date

May 14, 2029

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 Crohn's Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Exclusion Criteria:

Participants with Ulcerative Colitis (UC) or indeterminate colitis
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Participants receiving prohibited medications or therapies
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:Injection solution Route of administration:SC injection

Placebo

Pharmaceutical form:Injection solution Route of administration:SC injection

Primary outcome measure

Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12 [ Time Frame: Week 12 ]
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12 [ Time Frame: Week 12 ]
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12 [ 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

Del Sol Research Management, LLC-Site Number: 8400012

Recruiting

Tucson, Arizona, United States, 85715

Preferred Research Partners: 8400018

Recruiting

Little Rock, Arkansas, United States, 72211

Kagoshima IBD Gastroenterology Clinic - 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

TLC Clinical Research Inc.: 8400030

Recruiting

Los Angeles, California, United States, 90048

United Medical Doctors CA-Site Number: 8400044

Recruiting

Murrieta, California, United States, 92563

Prospective Research Innovations Inc.: 8400017

Recruiting

Rancho Cucamonga, California, United States, 91730

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

Valiance Clinical Research - Tarzana: 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

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

Novum Research, LLC-Site Number: 8400003

Recruiting

Clermont, Florida, United States, 34711

Precision Clinical Research: 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

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

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: 8400028

Recruiting

Sandy Springs, Georgia, United States, 30328

EBGS Clinical Research Center, LLC-Site Number 8400037

Recruiting

Snellville, Georgia, United States, 30078

Grand Teton Research Group, PLLC-Site Number: 8400127

Recruiting

Idaho Falls, Idaho, United States, 83404

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, 60031

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

Cedar Valley Digestive Health Center-Site Number: 8400096

Recruiting

Waterloo, Iowa, United States, 50701

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, 70360

Gastro Group-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-Site Number: 8400087

Recruiting

Monroe, Louisiana, United States, 71291

Care Access - New Iberia-Site Number: 8400031

Recruiting

New Iberia, Louisiana, United States, 70560

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

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

Recruiting

Jackson, Mississippi, United States, 08527

Gateway Gastroenterology: 8400097

Recruiting

Chesterfield, Missouri, United States, 63017

BVL Clinical Research: 8400005

Recruiting

Liberty, Missouri, United States, 64068

Las Vegas Clinical Trials- Site Number: 8400079

Recruiting

Las Vegas, Nevada, United States, 89030

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

Tandem-Allied Clinical Research - Somers Point- Site Number: 8400050

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

New York Gastroenterology Associates-Site Number: 8400009

Recruiting

New York, New York, United States, 10075

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

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.: 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

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

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-Site Number: 8400089

Recruiting

West Columbia, South Carolina, United States, 29169

Tri-Cities Gastroenterology-Site Number: 8400076

Recruiting

Kingsport, Tennessee, United States, 37663

Valley Institute of Research: 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

SMS Clinical Research-Site Number: 8400035

Recruiting

Mesquite, Texas, United States, 75149

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: 8400029

Recruiting

Tomball, Texas, United States, 77375

Tyler Research Institute, LLC: 8400095

Recruiting

Tyler, Texas, United States, 75701

Blue Ridge Medical Research: 8400020

Recruiting

Lynchburg, Virginia, United States, 24502

Clinical Research Partners - Site Number: 8400080

Recruiting

Richmond, Virginia, United States, 23226

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

Recruiting

Vancouver, Washington, United States, 98664

Investigational Site Number : 1240014

Recruiting

Brampton, Canada, L6S 0C1

Investigational Site Number : 1240004

Recruiting

Edmonton, Canada, T6G 2X8

Investigational Site Number: 1240009

Recruiting

Hamilton, Canada, L8N 1Y2

Investigational Site Number : 1240013

Recruiting

London, Canada, N6K 1M6

Investigational Site Number: 1240006

Recruiting

New Westminster, Canada, BC V3L 3W4

Investigational Site Number: 1240010

Recruiting

Oakville, Canada, L6L 5L7

Investigational Site Number: 1240003

Recruiting

Toronto, Canada, M6A 3B4

More Information

Sponsor

Sanofi

Last update posted

Jul 1, 2026

Last verified

Jun, 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 2026-07-01.