Tests duvakitug in adults with active Crohn's disease
Tests duvakitug against placebo in people with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Atlanta, Aurora, Baltimore, Baton Rouge, Baytown, Bellevue, Boston, Canoga Park, Canton, Chapel Hill, Charlotte, Chicago, Clermont, Cleveland, Clive, Colorado Springs, Columbia, Columbus, Cordova, Coronado, Dallas, Dayton, Denver, Des Plaines, Durham, East Orange, Escondido, Fargo, Fayetteville, Folsom, Freehold, Gainesville, Glenview, Gurnee, Harlingen, Hershey, Houma, Idaho Falls, Jackson, Kansas City, Kingsport, Kingwood, Kissimmee, Lake Jackson, Lancaster, Las Vegas, Laurel, Lexington, Liberty, Little Rock, Los Angeles, Lubbock, Lynchburg, Mandeville, Marrero, Maspeth, Mesquite, Metairie, Miami, Milwaukee, Monroe, Morristown, Murrieta, New Albany, New Haven, New Iberia, New York, Norman, Novi, Orlando, Oxnard, Palmetto Bay, Peoria, Philadelphia, Pittsburgh, Portland, Providence, Raleigh, Rancho Cucamonga, Richmond, Sacramento, San Antonio, San Diego, Sandy Springs, Scottsdale, Snellville, Somers Point, Southlake, Sparta, Springboro, St Louis, Sunrise, Suwanee, Tampa, Tarzana, The Bronx, Thousand Oaks, Toledo, Tomball, Tucson, Tyler, Valencia, Vancouver, Victorville, Waterloo, West Jordan, Westlake, Worcester, and Wyoming, United StatesSee the 127 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT07184931, who can take part
Where in United States
- Atlanta Gastroenterology Associates-Site Number: 8400109Atlanta, United StatesTaking people
- UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085Aurora, United StatesTaking people
- Mercy Medical Center, Baltimore-Site Number: 8400117Baltimore, United StatesTaking people
- GI Alliance - Baton Rouge-Site Number: 8400129Baton Rouge, United StatesTaking people
- Inquest Clinical Research-Site Number: 8400144Baytown, United StatesTaking people
- GI Alliance - Bellevue-Site Number: 8400143Bellevue, United StatesTaking people
- Tufts Medical Center-Site Number: 8400126Boston, United StatesTaking people
- Alliance Research Institute-Site Number: 8400008Canoga Park, United StatesTaking people
- Gastroenterology & Hepatology Specialists, Inc.-Site nUmber: 8400139Canton, United StatesTaking people
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074Chapel Hill, United StatesTaking people
- OnSite Clinical Solutions-Site Number: 8400051Charlotte, United StatesTaking people
- Rush University Medical Center-Site Number: 8400015Chicago, United StatesTaking people
- Novum Research, LLC-Site Number: 8400003Clermont, United StatesTaking people
- University Hospitals Cleveland Medical Center-Site Number: 8400073Cleveland, United StatesTaking people
- Heartland Medical Research, Inc.-Site Number: 8400134Clive, United StatesTaking people
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Colorado Springs, United StatesTaking people
- Biocentric Health Research Center-Site Number: 8400089Columbia, United StatesTaking people
- Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116Columbia, United StatesTaking people
- Ohio Gastroenterology Group Inc.-8400006Columbus, United StatesTaking people
- OSU Wexner Medical Center-Site Number: 8400077Columbus, United StatesTaking people
- Gastro One - Cordova-Site Number: 8400158Cordova, United StatesTaking people
- Southern California GI & Liver Centers-Site Number: 8400062Coronado, United StatesTaking people
- The University of Texas Southwestern Medical Center-Site Number: 8400098Dallas, United StatesTaking people
- DSI Research Northridge - Dayton-Site Number: 8400115Dayton, United StatesTaking people
- Gastroenterology of the Rockies - Denver-Site Number: 8400122Denver, United StatesTaking people
- Midwest Digestive Health and Nutrition-Site Number: 8400136Des Plaines, United StatesTaking people
- Duke University Medical Center-Site Number: 8400093Durham, United StatesTaking people
- Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123East Orange, United StatesTaking people
- Gastroenterology and Liver Institute - Escondido-Site Number: 8400146Escondido, United StatesTaking people
- Plains Clinical Research Center-Site Number: 8400078Fargo, United StatesTaking people
- Cross Creek Medical Clinic-Site Number: 8400057Fayetteville, United StatesTaking people
- GMC Clinical Research, LLC-Site Number: 8400113Folsom, United StatesTaking people
- Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014Freehold, United StatesTaking people
- Sarkis Clinical Trials - Gainesville-Site Number: 8400048Gainesville, United StatesTaking people
- GI Alliance - Glenview-Site Number: 8400068Glenview, United StatesTaking people
- GI Alliance - Gurnee-Site Number: 8400049Gurnee, United StatesTaking people
- Valley Institute of Research-Site Number: 8400004Harlingen, United StatesTaking people
- Penn State Milton S. Hershey Medical Center-Site Number: 8400066Hershey, United StatesTaking people
- Tandem Intermediate, LLC - Houma-Site Number: 8400034Houma, United StatesTaking people
- Grand Teton Research Group, PLLC-Site Number: 8400127Idaho Falls, United StatesTaking people
- Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007Jackson, United StatesTaking people
- University of Kansas Medical Center-Site Number: 8400110Kansas City, United StatesTaking people
- Tri-Cities Gastroenterology-Site Number: 8400076Kingsport, United StatesTaking people
- One of a Kind Clinical Research Center TX, LLC-Site Number; 8400125Kingwood, United StatesTaking people
- Clinical Research of Osceola-Site Number: 8400013Kissimmee, United StatesTaking people
- Innovare Research Group-Site number: 8400067Lake Jackson, United StatesTaking people
- Om Research, LLC - Lancaster-Site Number: 8400148Lancaster, United StatesTaking people
- Las Vegas Clinical Trials-Site Number: 8400079Las Vegas, United StatesTaking people
- Mid-Atlantic GI Research, LLC-Site Number: 8400106Laurel, United StatesTaking people
- University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058Lexington, United StatesTaking people
- BVL Clinical Research-Site Number: 8400005Liberty, United StatesTaking people
- Preferred Research Partners-Site Number: 8400018Little Rock, United StatesTaking people
- GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019Los Angeles, United StatesTaking people
- TLC Clinical Research Inc.-Site Number: 8400030Los Angeles, United StatesTaking people
- GI Alliance - Lubbock-Site Number: 8400092Lubbock, United StatesTaking people
- Blue Ridge Medical Research-Site Number: 8400020Lynchburg, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128Mandeville, United StatesTaking people
- Tandem Clinical Research - Marrero-Site Number: 8400002Marrero, United StatesTaking people
- MedTraits NY-Site Number: 8400045Maspeth, United StatesTaking people
- SMS Clinical Research-Site Number: 8400035Mesquite, United StatesTaking people
- GI Alliance - Metairie-Site Number: 8400124Metairie, United StatesTaking people
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053Miami, United StatesTaking people
- Columbus Clinical Services LLc-Site Number: 8400038Miami, United StatesTaking people
- Correa Research Center-Site Number: 8400010Miami, United StatesTaking people
- Medical Professional Clinical Research Center-Site Number: 8400119Miami, United StatesTaking people
- Paradisus Med Research-Site Number: 8400036Miami, United StatesTaking people
- Regis Clinical Research, LLC-Site Number: 8400041Miami, United StatesTaking people
- Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111Miami, United StatesTaking people
- Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081Milwaukee, United StatesTaking people
- Delta Research Partners-Site Number: 8400087Monroe, United StatesTaking people
- Monroe Biomedical Research-Site Number: 8400046Monroe, United StatesTaking people
- Atlantic Health System, Morristown Medical Center-Site Number: 8400137Morristown, United StatesTaking people
- United Medical Doctors CA-Site Number: 8400044Murrieta, United StatesTaking people
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100New Albany, United StatesTaking people
- Yale University Digestive Disease-Site Number: 8400108New Haven, United StatesTaking people
- Care Access - New Iberia-Site Number: 8400031New Iberia, United StatesTaking people
- Columbia University Medical Center-Site Number: 8400138New York, United StatesTaking people
- Manhattan Clinical Research, LLC-Site Number: 8400069New York, United StatesTaking people
- New York Gastroenterology Associates-Site Number: 8400009New York, United StatesTaking people
- NYU Langone Health-Site Number: 8400091New York, United StatesTaking people
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040New York, United StatesTaking people
- Central Sooner Research-Site Number: 8400094Norman, United StatesTaking people
- Henry Ford Medical Center - Columbus-Site Number: 8400118Novi, United StatesTaking people
- AdventHealth Orlando-Site Number: 8400070Orlando, United StatesTaking people
- Orlando Health, Inc.-Site Number: 8400084Orlando, United StatesTaking people
- Om Research, LLC - Oxnard-Site Number: 8400150Oxnard, United StatesTaking people
- Tropical Clinical Trials-Site Number: 8400082Palmetto Bay, United StatesTaking people
- PeoriaPeoria, United StatesTaking people
- University of Pennsylvania School of Medicine-Site Number: 8400072Philadelphia, United StatesTaking people
- The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107Pittsburgh, United StatesTaking people
- Oregon Health & Science University-Site Number: 8400131Portland, United StatesTaking people
- University Gastroenterology-Site Number: 8400103Providence, United StatesTaking people
- ClinTrial Research, LLC-Site Number: 8400043Raleigh, United StatesTaking people
- Prospective Research Innovations Inc.-Site Number: 8400017Rancho Cucamonga, United StatesTaking people
- Clinical Research Partners-Site Number: 8400080Richmond, United StatesTaking people
- UC Davis Health System-Site Number: 8400071Sacramento, United StatesTaking people
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054San Antonio, United StatesTaking people
- Clinical Applications Laboratories Inc-Site Number: 8400056San Diego, United StatesTaking people
- Medical Associates Research Group-Site Number:8400063San Diego, United StatesTaking people
- M3 Wake Research - Atlanta-Site Number: 8400028Sandy Springs, United StatesTaking people
- One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061Scottsdale, United StatesTaking people
- Scottsdale Clinical Trials-Site Number: 8400145Scottsdale, United StatesTaking people
- EBGS Clinical Research Center, LLC-Site Number: 8400037Snellville, United StatesTaking people
- Tandem-Allied Clinical Research - Somers Point-Site Number: 8400050Somers Point, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101Southlake, United StatesTaking people
- Premier Health Research, LLC-Site Number: 8400114Sparta, United StatesTaking people
- DSI Research - Springboro-Site Number: 8400105Springboro, United StatesTaking people
- Gateway Gastroenterology-Site Number: 8400097St Louis, United StatesTaking people
- Washington University School of Medicine-Site Number: 8400075St Louis, United StatesTaking people
- Precision Clinical Research - Sunrise-Site Number: 8400059Sunrise, United StatesTaking people
- Atlanta Gastroenterology Specialists-Site Number: 8400149Suwanee, United StatesTaking people
- NMC Research LLC-Site Number: 8400033Tampa, United StatesTaking people
- Valiance Clinical Research - Tarzana-Site Number: 8400023Tarzana, United StatesTaking people
- Montefiore Medical Center - Bronx-Site Number: 8400142The Bronx, United StatesTaking people
- Clinical Trials Management Services-Site Number: 8400047Thousand Oaks, United StatesTaking people
- University of Toledo Medical Center-Site Number: 8400042Toledo, United StatesTaking people
- Texas Gastro Consultants-Site Number: 8400029Tomball, United StatesTaking people
- Del Sol Research Management, LLC-Site Number: 8400012Tucson, United StatesTaking people
- Tyler Research Institute, LLC-Site Number: 8400095Tyler, United StatesTaking people
- Amicis Research Center - Valencia-Site Number: 8400064Valencia, United StatesTaking people
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090Vancouver, United StatesTaking people
- Om Research, LLC - Victorville-Site Number: 8400022Victorville, United StatesTaking people
- Digestive Health Research Center-Site Number: 8400096Waterloo, United StatesTaking people
- Velocity Clinical Research, Salt Lake City-Site Number: 8400147West Jordan, United StatesTaking people
- North Shore Gastroenterology Research-Site Number: 8400130Westlake, United StatesTaking people
- UMass Memorial Medical Center-Site Number: 8400121Worcester, United StatesTaking people
- Gastroenterology Associates of Western Michigan-Site Number: 8400060Wyoming, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07184931
- Record updated
- 21 October 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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.