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

NCT07184931 · Sanofi
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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
About this study
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.
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.
Study design
Enrollment target: 980 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2025-10-01
Estimated completion: 2029-05-14
Last updated: 2026-03-31
Interventions
Drug: DuvakitugDrug: Placebo
Primary outcomes
  • Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 (Week 12)
  • Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn&#x0027;s Disease [SES-CD]) at Week 12 (Week 12)
  • Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12 (Week 12)
Sponsor
Sanofi · industry
With: Teva Branded Pharmaceutical Products R&D LLC
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · Contact-US@sanofi.com · 800-633-1610
All locations (130)
Onyx Clinical Research - Site Number: 8400021Recruiting
Peoria, Arizona, United States
One of a Kind Clinical Research Center LLC-Site Number: 8400061Recruiting
Scottsdale, Arizona, United States
Del Sol Research Management, LLC-Site Number: 8400012Recruiting
Tucson, Arizona, United States
Preferred Research Partners: 8400018Recruiting
Little Rock, Arkansas, United States
Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008Recruiting
Canoga Park, California, United States
Southern California GI & Liver Centers-Site Number: 8400062Recruiting
Coronado, California, United States
GMC Clinical Research, LLC-Site Number: 8400113Recruiting
Folsom, California, United States
TLC Clinical Research Inc.: 8400030Recruiting
Los Angeles, California, United States
United Medical Doctors CA-Site Number: 8400044Recruiting
Murrieta, California, United States
Prospective Research Innovations Inc.: 8400017Recruiting
Rancho Cucamonga, California, United States
Medical Associates Research Group-Site Number: 8400063Recruiting
San Diego, California, United States
Valiance Clinical Research - Tarzana: 8400023Recruiting
Tarzana, California, United States
Clinical Trials Management Services-Site Number: 8400047Recruiting
Thousand Oaks, California, United States
Amicis Research Center-Valencia-Site Number: 8400064Recruiting
Valencia, California, United States
Om Research, LLC - Victorville - Site Number: 8400022Recruiting
Victorville, California, United States
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Recruiting
Colorado Springs, Colorado, United States
Gastroenterology of the Rockies - Denver-Site Number: 8400122Recruiting
Denver, Colorado, United States
Novum Research, LLC-Site Number: 8400003Recruiting
Clermont, Florida, United States
Precision Clinical Research: 8400059Recruiting
Coral Springs, Florida, United States
Sarkis Clinical Trials-Ocala-Site Number: 8400048Recruiting
Gainesville, Florida, United States
Clinical Research of Osceola-Site Number: 8400013Recruiting
Kissimmee, Florida, United States
Columbus Clinical Services LLc-Site Number: 8400038Recruiting
Miami, Florida, United States
Regis Clinical Research, LLC-Site Number: 8400041Recruiting
Miami, Florida, United States
Bio Research Partner-Site Number: 8400053Recruiting
Miami, Florida, United States
Medical Professional Clinical Research Center-Site Number: 8400119Recruiting
Miami, Florida, United States
Correa Research Center-Site Number: 8400010Recruiting
Miami, Florida, United States
Orlando Health, Inc.-Site Number: 8400084Recruiting
Orlando, Florida, United States
Tropical Clinical Trials-Site Number: 8400082Recruiting
Palmetto Bay, Florida, United States
NMC Research LLC - Site Number: 8400033Recruiting
Tampa, Florida, United States
Atlanta Gastroenterology Associates-Site Number: 8400109Recruiting
Atlanta, Georgia, United States
M3 Wake Research - Atlanta: 8400028Recruiting
Sandy Springs, Georgia, United States
EBGS Clinical Research Center, LLC-Site Number 8400037Recruiting
Snellville, Georgia, United States
Grand Teton Research Group, PLLC-Site Number: 8400127Recruiting
Idaho Falls, Idaho, United States
Midwest Digestive Health and Nutrition-Site Number: 8400136Recruiting
Des Plaines, Illinois, United States
GI Alliance - Glenview - Site Number: 8400068Recruiting
Glenview, Illinois, United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049Recruiting
Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC - Site Number: 8400100Recruiting
New Albany, Indiana, United States
Cedar Valley Digestive Health Center-Site Number: 8400096Recruiting
Waterloo, Iowa, United States
GI Alliance - Baton Rouge - Site Number: 8400129Recruiting
Baton Rouge, Louisiana, United States
Tandem Intermediate, LLC - Houma-Site Number: 8400034Recruiting
Houma, Louisiana, United States
Gastro Group-Site Number: 8400128Recruiting
Mandeville, Louisiana, United States
Tandem Clinical Research - Marrero-Site Number: 8400002Recruiting
Marrero, Louisiana, United States
GI Alliance - Metairie-Site Number: 8400124Recruiting
Metairie, Louisiana, United States
Delta Research Partners-Site Number: 8400087Recruiting
Monroe, Louisiana, United States
Care Access - New Iberia-Site Number: 8400031Recruiting
New Iberia, Louisiana, United States
Mid-Atlantic GI Research, LLC - Site Number: 8400106Recruiting
Greenbelt, Maryland, United States
UMass Memorial Medical Center-Site Number: 8400121Recruiting
Worcester, Massachusetts, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060Recruiting
Wyoming, Michigan, United States
Allied Health Clinical Research Organization, LLC - Jackson-Site Number: 8400007Recruiting
Jackson, Mississippi, United States
Gateway Gastroenterology: 8400097Recruiting
Chesterfield, Missouri, United States
BVL Clinical Research: 8400005Recruiting
Liberty, Missouri, United States
Las Vegas Clinical Trials- Site Number: 8400079Recruiting
Las Vegas, Nevada, United States
Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123Recruiting
East Orange, New Jersey, United States
Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014Recruiting
Freehold, New Jersey, United States
Tandem-Allied Clinical Research - Somers Point- Site Number: 8400050Recruiting
Somers Point, New Jersey, United States
Premier Health Research, LLC - Site Number: 8400114Recruiting
Sparta, New Jersey, United States
MedTraits NY-Site Number: 8400045Recruiting
Maspeth, New York, United States
Manhattan Clinical Research, LLC - Site Number: 8400069Recruiting
New York, New York, United States
NYU Langone Health- Site Number: 8400091Recruiting
New York, New York, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital-Site Number: 8400040Recruiting
New York, New York, United States
New York Gastroenterology Associates-Site Number: 8400009Recruiting
New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074Recruiting
Chapel Hill, North Carolina, United States
OnSite Clinical Solutions-Site Number: 8400051Recruiting
Charlotte, North Carolina, United States
Cross Creek Medical Clinic-Site Number: 8400057Recruiting
Fayetteville, North Carolina, United States
Monroe Biomedical Research - Site Number: 8400046Recruiting
Monroe, North Carolina, United States
ClinTrial Research, LLC - Site Number: 8400043Recruiting
Raleigh, North Carolina, United States
Plains Medical Clinic-Site Number: 8400078Recruiting
Fargo, North Dakota, United States
Gastroenterology & Hepatology Specialists, Inc.-Site Number: 8400139Recruiting
Canton, Ohio, United States
Ohio Gastroenterology Group Inc.: 8400006Recruiting
Columbus, Ohio, United States
OSU Wexner Medical Center- Site Number: 8400077Recruiting
Columbus, Ohio, United States
DSI Research, LLC-Site Number: 8400115Recruiting
Dayton, Ohio, United States
DSI Research, LLC - Site Number: 8400105Recruiting
Springboro, Ohio, United States
North Shore Gastroenterology Research - Site Number: 8400130Recruiting
Westlake, Ohio, United States
Central Sooner Research-Site Number: 8400094Recruiting
Norman, Oklahoma, United States
University of Pennsylvania School of Medicine- Site Number: 8400072Recruiting
Philadelphia, Pennsylvania, United States
University Gastroenterology - GI Alliance - Site Number: 8400103Recruiting
Providence, Rhode Island, United States
Biocentric Health Research Partner-Site Number: 8400089Recruiting
West Columbia, South Carolina, United States
Tri-Cities Gastroenterology-Site Number: 8400076Recruiting
Kingsport, Tennessee, United States
Valley Institute of Research: 8400004Recruiting
Harlingen, Texas, United States
One of a Kind Clinical Research Center LLC - Texas-Site Number: 8400125Recruiting
Kingwood, Texas, United States
Innovare Research Group-Site Number: 8400067Recruiting
Lake Jackson, Texas, United States
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092Recruiting
Lubbock, Texas, United States
SMS Clinical Research-Site Number: 8400035Recruiting
Mesquite, Texas, United States
Gastroenterology Research of San Antonio LLC-Site Number: 8400054Recruiting
San Antonio, Texas, United States
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101Recruiting
Southlake, Texas, United States
Texas Gastro Consultants: 8400029Recruiting
Tomball, Texas, United States
Tyler Research Institute, LLC: 8400095Recruiting
Tyler, Texas, United States
Blue Ridge Medical Research: 8400020Recruiting
Lynchburg, Virginia, United States
Clinical Research Partners - Site Number: 8400080Recruiting
Richmond, Virginia, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090Recruiting
Vancouver, Washington, United States
Investigational Site Number: 1240009Recruiting
Hamilton, Canada
Investigational Site Number: 1240010Recruiting
Oakville, Canada
Investigational Site Number: 1240003Recruiting
Toronto, Canada
Investigational Site Number : 2680002Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680004Recruiting
Tbilisi, Georgia
Investigational Site Number : 3920059Recruiting
Bunkyō City, Japan
Investigational Site Number : 3920027Recruiting
Fukuoka, Japan
-Site Number : 3920028Recruiting
Isesaki, Japan
Kagoshima IBD Gastroenterology Clinic Site Number : 3920049Recruiting
Kagoshima, Japan
Ofuna Chuo Hospital: 3920029Recruiting
Kamakura, Japan
Kokikai Tsujinaka Hospital Kashiwanoha: 3920031Recruiting
Kashiwa, Japan
Aoyama Clinic-Site Number: 3920018Recruiting
Kobe, Japan
Investigational Site Number : 3920036Recruiting
Kumamoto, Japan
National Hospital Organization Osaka National Hospital-Site Number : 3920002Recruiting
Osaka, Japan
Sapporo Tokushukai Hospital-Site Number: 3920019Recruiting
Sapporo, Japan
-Site Number : 3920042Recruiting
Sapporo, Japan
Investigational Site Number : 3920004Recruiting
Sendai, Japan
National Hospital Organization Sendai Medical Center-Site Number : 3920003Recruiting
Sendai, Japan
Investigational Site Number : 3920020Recruiting
Shiwa-gun, Japan
Tokai University Hachioji Hospital: 3920030Recruiting
Tokyo, Japan
Toyama University Hospital: 3920032Recruiting
Toyama, Japan
Investigational Site Number : 3920037Recruiting
Toyama, Japan
Mie University Hospital-Site Number : 3920009Recruiting
Tsu, Japan
Investigational Site Number : 4980002Recruiting
Chisinau, Moldova
Investigational Site Number : 4980003Recruiting
Chisinau, Moldova
Investigational Site Number : 4980004Recruiting
Chisinau, Moldova
Wellness Clinical Research - Vega Baja: 8400099Recruiting
Vega Baja, Puerto Rico
Investigational Site Number : 7100001Recruiting
Kempton Park, South Africa
Investigational Site Number : 7560001Recruiting
Bern, Switzerland
Investigational Site Number : 1580002Recruiting
Taipei, Taiwan
Investigational Site Number : 8040003Recruiting
Chernivtsi, Ukraine
Investigational Site Number : 8040001Recruiting
Kyiv, Ukraine
Investigational Site Number : 8040002Recruiting
Kyiv, Ukraine
Investigational Site Number : 8040004Recruiting
Lviv, Ukraine
Investigational Site Number : 8040005Recruiting
Lviv, Ukraine
Investigational Site Number : 8040011Recruiting
Lviv, Ukraine
Investigational Site Number : 8040006Recruiting
Uzhhorod, Ukraine
Investigational Site Number : 8040010Recruiting
Vinnytsia, Ukraine
Investigational Site Number : 8040009Recruiting
Vinnytsia, Ukraine
Investigational Site Number : 8040008Recruiting
Vinnytsia, Ukraine
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease · TrialPath