An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Sanofi · with Teva Branded Pharmaceutical Products R&D LLC · NCT07184931
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 16–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 980
- US sites recruiting
- 127
- Study start
- October 1, 2025
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Duvakitug; Placebo
Conditions: Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Onyx Clinical Research - Site Number:8400021
Peoria, AZ 85381
One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061
Scottsdale, AZ 85258
Scottsdale Clinical Trials-Site Number: 8400145
Scottsdale, AZ 85260
Del Sol Research Management, LLC-Site Number: 8400012
Tucson, AZ 85715
Preferred Research Partners-Site Number: 8400018
Little Rock, AR 72211
Alliance Research Institute-Site Number: 8400008
Canoga Park, CA 91304
Southern California GI & Liver Centers-Site Number: 8400062
Coronado, CA 92118-1408
Gastroenterology and Liver Institute - Escondido-Site Number: 8400146
Escondido, CA 92025
GMC Clinical Research, LLC-Site Number: 8400113
Folsom, CA 95630
Om Research, LLC - Lancaster-Site Number: 8400148
Lancaster, CA 93534
TLC Clinical Research Inc.-Site Number: 8400030
Los Angeles, CA 90048
GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019
Los Angeles, CA 90067
United Medical Doctors CA-Site Number: 8400044
Murrieta, CA 92563
Om Research, LLC - Oxnard-Site Number: 8400150
Oxnard, CA 93030
Prospective Research Innovations Inc.-Site Number: 8400017
Rancho Cucamonga, CA 91730
UC Davis Health System-Site Number: 8400071
Sacramento, CA 95817
Clinical Applications Laboratories Inc-Site Number: 8400056
San Diego, CA 92103
Medical Associates Research Group-Site Number:8400063
San Diego, CA 92123
Valiance Clinical Research - Tarzana-Site Number: 8400023
Tarzana, CA 91356
Clinical Trials Management Services-Site Number: 8400047
Thousand Oaks, CA 91360
Amicis Research Center - Valencia-Site Number: 8400064
Valencia, CA 91355
Om Research, LLC - Victorville-Site Number: 8400022
Victorville, CA 92395
UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085
Aurora, CO 80045
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, CO 80907
Gastroenterology of the Rockies - Denver-Site Number: 8400122
Denver, CO 80218
Yale University Digestive Disease-Site Number: 8400108
New Haven, CT 06510
Novum Research, LLC-Site Number: 8400003
Clermont, FL 34711
Sarkis Clinical Trials - Gainesville-Site Number: 8400048
Gainesville, FL 32607
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, FL 34741
Columbus Clinical Services LLc-Site Number: 8400038
Miami, FL 33125
Regis Clinical Research, LLC-Site Number: 8400041
Miami, FL 33126
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111
Miami, FL 33136
Medical Professional Clinical Research Center-Site Number: 8400119
Miami, FL 33165
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, FL 33175
Paradisus Med Research-Site Number: 8400036
Miami, FL 33185
Correa Research Center-Site Number: 8400010
Miami, FL 33186
AdventHealth Orlando-Site Number: 8400070
Orlando, FL 32803
Orlando Health, Inc.-Site Number: 8400084
Orlando, FL 32806
Tropical Clinical Trials-Site Number: 8400082
Palmetto Bay, FL 33176
Precision Clinical Research - Sunrise-Site Number: 8400059
Sunrise, FL 33351
NMC Research LLC-Site Number: 8400033
Tampa, FL 33607
Atlanta Gastroenterology Associates-Site Number: 8400109
Atlanta, GA 30342
M3 Wake Research - Atlanta-Site Number: 8400028
Sandy Springs, GA 30328
EBGS Clinical Research Center, LLC-Site Number: 8400037
Snellville, GA 30078
Atlanta Gastroenterology Specialists-Site Number: 8400149
Suwanee, GA 30024
Grand Teton Research Group, PLLC-Site Number: 8400127
Idaho Falls, ID 83404
Rush University Medical Center-Site Number: 8400015
Chicago, IL 60612
Midwest Digestive Health and Nutrition-Site Number: 8400136
Des Plaines, IL 60016
GI Alliance - Glenview-Site Number: 8400068
Glenview, IL 60026
GI Alliance - Gurnee-Site Number: 8400049
Gurnee, IL 60031
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
New Albany, IN 47150
Heartland Medical Research, Inc.-Site Number: 8400134
Clive, IA 50325
Digestive Health Research Center-Site Number: 8400096
Waterloo, IA 50701
University of Kansas Medical Center-Site Number: 8400110
Kansas City, KS 66160
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058
Lexington, KY 40536-0293
GI Alliance - Baton Rouge-Site Number: 8400129
Baton Rouge, LA 70809
Tandem Intermediate, LLC - Houma-Site Number: 8400034
Houma, LA 70360
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
Mandeville, LA 70471
Tandem Clinical Research - Marrero-Site Number: 8400002
Marrero, LA 70072
GI Alliance - Metairie-Site Number: 8400124
Metairie, LA 70006
+ 67 more on the official record.
Study contacts (from the official record)
- Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com