An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
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
- Crohn's Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Sanofi
- Enrolment target
- 980
- Started
- 1 October 2025
- Main results due
- 14 May 2029
- Study sites
- 432
- Registry updated
- 23 September 2026
Can you take part?
- Ages 16 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(432)
Onyx Clinical Research - Site Number:8400021
Peoria, Arizona, United States
Recruiting
One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061
Scottsdale, Arizona, United States
Recruiting
Scottsdale Clinical Trials-Site Number: 8400145
Scottsdale, Arizona, United States
Recruiting
Del Sol Research Management, LLC-Site Number: 8400012
Tucson, Arizona, United States
Recruiting
Preferred Research Partners-Site Number: 8400018
Little Rock, Arkansas, United States
Recruiting
Alliance Research Institute-Site Number: 8400008
Canoga Park, California, United States
Recruiting
Southern California GI & Liver Centers-Site Number: 8400062
Coronado, California, United States
Recruiting
Gastroenterology and Liver Institute - Escondido-Site Number: 8400146
Escondido, California, United States
Recruiting
GMC Clinical Research, LLC-Site Number: 8400113
Folsom, California, United States
Recruiting
Om Research, LLC - Lancaster-Site Number: 8400148
Lancaster, California, United States
Recruiting
TLC Clinical Research Inc.-Site Number: 8400030
Los Angeles, California, United States
Recruiting
GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019
Los Angeles, California, United States
Recruiting
United Medical Doctors CA-Site Number: 8400044
Murrieta, California, United States
Recruiting
Om Research, LLC - Oxnard-Site Number: 8400150
Oxnard, California, United States
Recruiting
Prospective Research Innovations Inc.-Site Number: 8400017
Rancho Cucamonga, California, United States
Recruiting
UC Davis Health System-Site Number: 8400071
Sacramento, California, United States
Recruiting
Clinical Applications Laboratories Inc-Site Number: 8400056
San Diego, California, United States
Recruiting
Medical Associates Research Group-Site Number:8400063
San Diego, California, United States
Recruiting
Valiance Clinical Research - Tarzana-Site Number: 8400023
Tarzana, California, United States
Recruiting
Clinical Trials Management Services-Site Number: 8400047
Thousand Oaks, California, United States
Recruiting
Amicis Research Center - Valencia-Site Number: 8400064
Valencia, California, United States
Recruiting
Om Research, LLC - Victorville-Site Number: 8400022
Victorville, California, United States
Recruiting
UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085
Aurora, Colorado, United States
Recruiting
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado, United States
Recruiting
Gastroenterology of the Rockies - Denver-Site Number: 8400122
Denver, Colorado, United States
Recruiting
Yale University Digestive Disease-Site Number: 8400108
New Haven, Connecticut, United States
Recruiting
Novum Research, LLC-Site Number: 8400003
Clermont, Florida, United States
Recruiting
Sarkis Clinical Trials - Gainesville-Site Number: 8400048
Gainesville, Florida, United States
Recruiting
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida, United States
Recruiting
Columbus Clinical Services LLc-Site Number: 8400038
Miami, Florida, United States
Recruiting
Regis Clinical Research, LLC-Site Number: 8400041
Miami, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111
Miami, Florida, United States
Recruiting
Medical Professional Clinical Research Center-Site Number: 8400119
Miami, Florida, United States
Recruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida, United States
Recruiting
Paradisus Med Research-Site Number: 8400036
Miami, Florida, United States
Recruiting
Correa Research Center-Site Number: 8400010
Miami, Florida, United States
Recruiting
AdventHealth Orlando-Site Number: 8400070
Orlando, Florida, United States
Recruiting
Orlando Health, Inc.-Site Number: 8400084
Orlando, Florida, United States
Recruiting
Tropical Clinical Trials-Site Number: 8400082
Palmetto Bay, Florida, United States
Recruiting
Precision Clinical Research - Sunrise-Site Number: 8400059
Sunrise, Florida, United States
Recruiting
NMC Research LLC-Site Number: 8400033
Tampa, Florida, United States
Recruiting
Atlanta Gastroenterology Associates-Site Number: 8400109
Atlanta, Georgia, United States
Recruiting
M3 Wake Research - Atlanta-Site Number: 8400028
Sandy Springs, Georgia, United States
Recruiting
EBGS Clinical Research Center, LLC-Site Number: 8400037
Snellville, Georgia, United States
Recruiting
Atlanta Gastroenterology Specialists-Site Number: 8400149
Suwanee, Georgia, United States
Recruiting
Grand Teton Research Group, PLLC-Site Number: 8400127
Idaho Falls, Idaho, United States
Recruiting
Rush University Medical Center-Site Number: 8400015
Chicago, Illinois, United States
Recruiting
Midwest Digestive Health and Nutrition-Site Number: 8400136
Des Plaines, Illinois, United States
Recruiting
GI Alliance - Glenview-Site Number: 8400068
Glenview, Illinois, United States
Recruiting
GI Alliance - Gurnee-Site Number: 8400049
Gurnee, Illinois, United States
Recruiting
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
New Albany, Indiana, United States
Recruiting
Heartland Medical Research, Inc.-Site Number: 8400134
Clive, Iowa, United States
Recruiting
Digestive Health Research Center-Site Number: 8400096
Waterloo, Iowa, United States
Recruiting
University of Kansas Medical Center-Site Number: 8400110
Kansas City, Kansas, United States
Recruiting
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058
Lexington, Kentucky, United States
Recruiting
GI Alliance - Baton Rouge-Site Number: 8400129
Baton Rouge, Louisiana, United States
Recruiting
Tandem Intermediate, LLC - Houma-Site Number: 8400034
Houma, Louisiana, United States
Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
Mandeville, Louisiana, United States
Recruiting
Tandem Clinical Research - Marrero-Site Number: 8400002
Marrero, Louisiana, United States
Recruiting
GI Alliance - Metairie-Site Number: 8400124
Metairie, Louisiana, United States
Recruiting
Showing 60 of 432 sites — filter to narrow it down. 432 of the 432 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07184931. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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