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NCT07184944PHASE3Recruiting

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

Sanofi

Start Date

1/22/2026

Completion Date

3/20/2034

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Eligibility Criteria

Age Range: 16 years to 80 years

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development) * Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1 * OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study Exclusion Criteria: * Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator * Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Interventions

DRUG

Duvakitug

DRUG

Placebo

Interested in This Trial?

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Conditions

Crohn's Disease

Locations

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Colorado Springs, Colorado 80907

United States

Clinical Research of Osceola-Site Number: 8400013

Kissimmee, Florida 34741

United States

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Miami, Florida 33175

United States

NMC Research LLC-Site Number: 8400033

Tampa, Florida 33607

United States

Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100

New Albany, Indiana 47150

United States

GI Alliance - Baton Rouge-Site Number: 8400129

Baton Rouge, Louisiana 70809

United States

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128

Mandeville, Louisiana 70471

United States

Gateway Gastroenterology-Site Number: 8400097

St Louis, Missouri 63141

United States

MedTraits NY-Site Number: 8400045

Maspeth, New York 11378

United States

NYU Langone Health-Site Number: 8400091

New York, New York 10016

United States

Weill Cornell Medicine - 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

Cross Creek Medical Clinic-Site Number: 8400057

Fayetteville, North Carolina 28304

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

North Shore Gastroenterology Research-Site Number: 8400130

Westlake, Ohio 44145

United States

University of Pennsylvania School of Medicine-Site Number: 8400072

Philadelphia, Pennsylvania 19104-6243

United States

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

Tyler Research Institute LLC-Site Number: 8400095

Tyler, Texas 75701

United States

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Wyoming, Wyoming 49519

United States

Investigational Site Number : 1240009

Hamilton, L8N 1Y2

Canada

Investigational Site Number : 1240003

Toronto, M6A 3B4

Canada

Investigational Site Number : 2680008

Tbilisi, 144

Georgia

Investigational Site Number : 2680003

Tbilisi, 159

Georgia

Investigational Site Number : 2680005

Tbilisi, 160

Georgia

Investigational Site Number : 2680002

Tbilisi, 180

Georgia

Investigational Site Number : 3920009

Tsu, 514-8507

Japan

Investigational Site Number : 4980003

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980004

Chisinau, MD-2068

Moldova

Investigational Site Number : 7100001

Kempton Park, 1619

South Africa

Investigational Site Number : 8040005

Lviv, 79019

Ukraine

Investigational Site Number : 8040010

Vinnytsia, 21013

Ukraine

Investigational Site Number : 8040009

Vinnytsia, 21028

Ukraine