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RECRUITING

NCT07184931

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Key Details

Gender

All

Age Range

16 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

980

Start Date

2025-10-01

Completion Date

2029-05-14

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Crohn's Disease

Interventions

DRUG

Duvakitug

Pharmaceutical form:Injection solution Route of administration:SC injection

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration:SC injection

Locations (432)

Onyx Clinical Research - Site Number:8400021

Peoria, Arizona, United States

One of a Kind Clinical Research Center AZ, 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

Alliance Research Institute-Site Number: 8400008

Canoga Park, California, United States

Southern California GI & Liver Centers-Site Number: 8400062

Coronado, California, United States

Gastroenterology and Liver Institute - Escondido-Site Number: 8400146

Escondido, 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

GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019

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

Prospective Research Innovations Inc.-Site Number: 8400017

Rancho Cucamonga, 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

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

Sarkis Clinical Trials - Gainesville-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

Medical Professional Clinical Research Center-Site Number: 8400119

Miami, Florida, United States

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Miami, Florida, United States

Paradisus Med Research-Site Number: 8400036

Miami, Florida, United States

Correa Research Center-Site Number: 8400010

Miami, Florida, United States

AdventHealth Orlando-Site Number: 8400070

Orlando, Florida, United States

Orlando Health, Inc.-Site Number: 8400084

Orlando, Florida, United States

Tropical Clinical Trials-Site Number: 8400082

Palmetto Bay, Florida, United States

Precision Clinical Research - Sunrise-Site Number: 8400059

Sunrise, 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

GI Alliance - Gurnee-Site Number: 8400049

Gurnee, Illinois, United States

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

New Albany, Indiana, United States

Heartland Medical Research, Inc.-Site Number: 8400134

Clive, Iowa, United States

Digestive Health Research 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

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-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-Site Number: 8400087

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

Laurel, Maryland, United States

Tufts Medical Center-Site Number: 8400126

Boston, Massachusetts, United States

UMass Memorial Medical Center-Site Number: 8400121

Worcester, Massachusetts, United States

Henry Ford Medical Center - Columbus-Site Number: 8400118

Novi, Michigan, United States

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Wyoming, Michigan, United States

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

Jackson, Mississippi, United States

BVL Clinical Research-Site Number: 8400005

Liberty, Missouri, United States

Washington University School of Medicine-Site Number: 8400075

St Louis, Missouri, United States

Gateway Gastroenterology-Site Number: 8400097

St Louis, Missouri, United States

Las Vegas Clinical Trials-Site Number: 8400079

Las Vegas, 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

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

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