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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07184931

Public ClinicalTrials.gov record NCT07184931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 3:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07184931
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
980 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2025
Primary completion
May 13, 2029
Completion
May 13, 2029
Last update posted
Sep 22, 2026

2025 – 2029

United States locations

U.S. sites
125
U.S. states
36
U.S. cities
108
Facility City State ZIP Site status
Onyx Clinical Research - Site Number:8400021 Peoria Arizona 85381 Recruiting
One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061 Scottsdale Arizona 85258 Recruiting
Scottsdale Clinical Trials-Site Number: 8400145 Scottsdale Arizona 85260 Recruiting
Del Sol Research Management, LLC-Site Number: 8400012 Tucson Arizona 85715 Recruiting
Preferred Research Partners-Site Number: 8400018 Little Rock Arkansas 72211 Recruiting
Alliance Research Institute-Site Number: 8400008 Canoga Park California 91304 Recruiting
Southern California GI & Liver Centers-Site Number: 8400062 Coronado California 92118-1408 Recruiting
Gastroenterology and Liver Institute - Escondido-Site Number: 8400146 Escondido California 92025 Recruiting
GMC Clinical Research, LLC-Site Number: 8400113 Folsom California 95630 Recruiting
Om Research, LLC - Lancaster-Site Number: 8400148 Lancaster California 93534 Recruiting
TLC Clinical Research Inc.-Site Number: 8400030 Los Angeles California 90048 Recruiting
GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019 Los Angeles California 90067 Recruiting
United Medical Doctors CA-Site Number: 8400044 Murrieta California 92563 Recruiting
Om Research, LLC - Oxnard-Site Number: 8400150 Oxnard California 93030 Recruiting
Prospective Research Innovations Inc.-Site Number: 8400017 Rancho Cucamonga California 91730 Recruiting
UC Davis Health System-Site Number: 8400071 Sacramento California 95817 Recruiting
Clinical Applications Laboratories Inc-Site Number: 8400056 San Diego California 92103 Recruiting
Medical Associates Research Group-Site Number:8400063 San Diego California 92123 Recruiting
Valiance Clinical Research - Tarzana-Site Number: 8400023 Tarzana California 91356 Recruiting
Clinical Trials Management Services-Site Number: 8400047 Thousand Oaks California 91360 Recruiting
Amicis Research Center - Valencia-Site Number: 8400064 Valencia California 91355 Recruiting
Om Research, LLC - Victorville-Site Number: 8400022 Victorville California 92395 Recruiting
UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085 Aurora Colorado 80045 Recruiting
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 Colorado Springs Colorado 80907 Recruiting
Gastroenterology of the Rockies - Denver-Site Number: 8400122 Denver Colorado 80218 Recruiting
Yale University Digestive Disease-Site Number: 8400108 New Haven Connecticut 06510 Recruiting
Novum Research, LLC-Site Number: 8400003 Clermont Florida 34711 Recruiting
Sarkis Clinical Trials - Gainesville-Site Number: 8400048 Gainesville Florida 32607 Recruiting
Clinical Research of Osceola-Site Number: 8400013 Kissimmee Florida 34741 Recruiting
Columbus Clinical Services LLc-Site Number: 8400038 Miami Florida 33125 Recruiting
Regis Clinical Research, LLC-Site Number: 8400041 Miami Florida 33126 Recruiting
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111 Miami Florida 33136 Recruiting
Medical Professional Clinical Research Center-Site Number: 8400119 Miami Florida 33165 Recruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053 Miami Florida 33175 Recruiting
Paradisus Med Research-Site Number: 8400036 Miami Florida 33185 Recruiting
Correa Research Center-Site Number: 8400010 Miami Florida 33186 Recruiting
AdventHealth Orlando-Site Number: 8400070 Orlando Florida 32803 Recruiting
Orlando Health, Inc.-Site Number: 8400084 Orlando Florida 32806 Recruiting
Tropical Clinical Trials-Site Number: 8400082 Palmetto Bay Florida 33176 Recruiting
Precision Clinical Research - Sunrise-Site Number: 8400059 Sunrise Florida 33351 Recruiting
NMC Research LLC-Site Number: 8400033 Tampa Florida 33607 Recruiting
Atlanta Gastroenterology Associates-Site Number: 8400109 Atlanta Georgia 30342 Recruiting
M3 Wake Research - Atlanta-Site Number: 8400028 Sandy Springs Georgia 30328 Recruiting
EBGS Clinical Research Center, LLC-Site Number: 8400037 Snellville Georgia 30078 Recruiting
Atlanta Gastroenterology Specialists-Site Number: 8400149 Suwanee Georgia 30024 Recruiting
Grand Teton Research Group, PLLC-Site Number: 8400127 Idaho Falls Idaho 83404 Recruiting
Rush University Medical Center-Site Number: 8400015 Chicago Illinois 60612 Recruiting
Midwest Digestive Health and Nutrition-Site Number: 8400136 Des Plaines Illinois 60016 Recruiting
GI Alliance - Glenview-Site Number: 8400068 Glenview Illinois 60026 Recruiting
GI Alliance - Gurnee-Site Number: 8400049 Gurnee Illinois 60031 Recruiting
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 New Albany Indiana 47150 Recruiting
Heartland Medical Research, Inc.-Site Number: 8400134 Clive Iowa 50325 Recruiting
Digestive Health Research Center-Site Number: 8400096 Waterloo Iowa 50701 Recruiting
University of Kansas Medical Center-Site Number: 8400110 Kansas City Kansas 66160 Recruiting
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058 Lexington Kentucky 40536-0293 Recruiting
GI Alliance - Baton Rouge-Site Number: 8400129 Baton Rouge Louisiana 70809 Recruiting
Tandem Intermediate, LLC - Houma-Site Number: 8400034 Houma Louisiana 70360 Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 Mandeville Louisiana 70471 Recruiting
Tandem Clinical Research - Marrero-Site Number: 8400002 Marrero Louisiana 70072 Recruiting
GI Alliance - Metairie-Site Number: 8400124 Metairie Louisiana 70006 Recruiting
Delta Research Partners-Site Number: 8400087 Monroe Louisiana 71201 Recruiting
Care Access - New Iberia-Site Number: 8400031 New Iberia Louisiana 70560 Recruiting
Mercy Medical Center, Baltimore-Site Number: 8400117 Baltimore Maryland 21202 Recruiting
Mid-Atlantic GI Research, LLC-Site Number: 8400106 Laurel Maryland 20708 Recruiting
Tufts Medical Center-Site Number: 8400126 Boston Massachusetts 02111 Recruiting
UMass Memorial Medical Center-Site Number: 8400121 Worcester Massachusetts 01655 Recruiting
Henry Ford Medical Center - Columbus-Site Number: 8400118 Novi Michigan 48377 Recruiting
Gastroenterology Associates of Western Michigan-Site Number: 8400060 Wyoming Michigan 49519 Recruiting
Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007 Jackson Mississippi 08527 Recruiting
BVL Clinical Research-Site Number: 8400005 Liberty Missouri 64068 Recruiting
Washington University School of Medicine-Site Number: 8400075 St Louis Missouri 63110 Recruiting
Gateway Gastroenterology-Site Number: 8400097 St Louis Missouri 63141 Recruiting
Las Vegas Clinical Trials-Site Number: 8400079 Las Vegas Nevada 89030 Recruiting
Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123 East Orange New Jersey 07018 Recruiting
Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014 Freehold New Jersey 07728 Recruiting
Tandem-Allied Clinical Research - Somers Point-Site Number: 8400050 Somers Point New Jersey 08244 Recruiting
Premier Health Research, LLC-Site Number: 8400114 Sparta New Jersey 07871 Recruiting
MedTraits NY-Site Number: 8400045 Maspeth New York 11378 Recruiting
Manhattan Clinical Research, LLC-Site Number: 8400069 New York New York 10016 Recruiting
NYU Langone Health-Site Number: 8400091 New York New York 10016 Recruiting
Columbia University Medical Center-Site Number: 8400138 New York New York 10032 Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 New York New York 10065 Recruiting
New York Gastroenterology Associates-Site Number: 8400009 New York New York 10075 Recruiting
Montefiore Medical Center - Bronx-Site Number: 8400142 The Bronx New York 10467 Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 Chapel Hill North Carolina 27514 Recruiting
OnSite Clinical Solutions-Site Number: 8400051 Charlotte North Carolina 28211 Recruiting
Duke University Medical Center-Site Number: 8400093 Durham North Carolina 27710 Recruiting
Cross Creek Medical Clinic-Site Number: 8400057 Fayetteville North Carolina 28304 Recruiting
Monroe Biomedical Research-Site Number: 8400046 Monroe North Carolina 28112 Recruiting
ClinTrial Research, LLC-Site Number: 8400043 Raleigh North Carolina 27612 Recruiting
Plains Clinical Research Center-Site Number: 8400078 Fargo North Dakota 58104 Recruiting
Gastroenterology & Hepatology Specialists, Inc.-Site nUmber: 8400139 Canton Ohio 44718 Recruiting
University Hospitals Cleveland Medical Center-Site Number: 8400073 Cleveland Ohio 44106-5077 Recruiting
Ohio Gastroenterology Group Inc.-8400006 Columbus Ohio 43202 Recruiting
OSU Wexner Medical Center-Site Number: 8400077 Columbus Ohio 43210 Recruiting
DSI Research Northridge - Dayton-Site Number: 8400115 Dayton Ohio 45414 Recruiting
DSI Research - Springboro-Site Number: 8400105 Springboro Ohio 45066 Recruiting
University of Toledo Medical Center-Site Number: 8400042 Toledo Ohio 43614 Recruiting
North Shore Gastroenterology Research-Site Number: 8400130 Westlake Ohio 44145 Recruiting
Central Sooner Research-Site Number: 8400094 Norman Oklahoma 73071 Recruiting
Oregon Health & Science University-Site Number: 8400131 Portland Oregon 97239 Recruiting
Penn State Milton S. Hershey Medical Center-Site Number: 8400066 Hershey Pennsylvania 17033-0850 Recruiting
University of Pennsylvania School of Medicine-Site Number: 8400072 Philadelphia Pennsylvania 19104-6243 Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 Pittsburgh Pennsylvania 15212 Recruiting
University Gastroenterology-Site Number: 8400103 Providence Rhode Island 02904 Recruiting
Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116 Columbia South Carolina 21045 Recruiting
Biocentric Health Research Center-Site Number: 8400089 Columbia South Carolina 29203 Recruiting
Tri-Cities Gastroenterology-Site Number: 8400076 Kingsport Tennessee 37663 Recruiting
Inquest Clinical Research-Site Number: 8400144 Baytown Texas 77521 Recruiting
The University of Texas Southwestern Medical Center-Site Number: 8400098 Dallas Texas 75390 Recruiting
Valley Institute of Research-Site Number: 8400004 Harlingen Texas 78550 Recruiting
One of a Kind Clinical Research Center TX, LLC-Site Number; 8400125 Kingwood Texas 77339 Recruiting
Innovare Research Group-Site number: 8400067 Lake Jackson Texas 77566 Recruiting
GI Alliance - Lubbock-Site Number: 8400092 Lubbock Texas 79410 Recruiting
SMS Clinical Research-Site Number: 8400035 Mesquite Texas 75149 Recruiting
Gastroenterology Research of San Antonio LLC-Site Number: 8400054 San Antonio Texas 78229 Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101 Southlake Texas 76092 Recruiting
Texas Gastro Consultants-Site Number: 8400029 Tomball Texas 77375 Recruiting
Tyler Research Institute, LLC-Site Number: 8400095 Tyler Texas 75701 Recruiting
Velocity Clinical Research, Salt Lake City-Site Number: 8400147 West Jordan Utah 84088 Recruiting
Blue Ridge Medical Research-Site Number: 8400020 Lynchburg Virginia 24502 Recruiting
Clinical Research Partners-Site Number: 8400080 Richmond Virginia 23226 Recruiting
GI Alliance - Bellevue-Site Number: 8400143 Bellevue Washington 98004 Recruiting
The Vancouver Clinic Inc. P.S.-Site Number: 8400090 Vancouver Washington 98664 Recruiting
Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081 Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 307 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07184931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2026 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07184931 live on ClinicalTrials.gov.

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