Taking people in United StatesPhase 3
Tests duvakitug against placebo in ulcerative colitis
Tests duvakitug versus placebo in adults with moderately to severely active ulcerative colitis.
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 Ulcerative Colitis
Key facts
- Where
- Arcadia, Atlanta, Aurora, Baltimore, Baton Rouge, Baytown, Bellevue, Boston, Canoga Park, Canton, Chapel Hill, Charlotte, Chesterfield, Chicago, Clermont, Clive, Colorado Springs, Columbus, Coral Springs, Cordova, Coronado, Dallas, Dayton, Denver, Des Plaines, Durham, East Orange, Fargo, Fayetteville, Folsom, Freehold, Gainesville, Glenview, Greenbelt, Gurnee, Harlingen, Hershey, Houma, Idaho Falls, Jackson, Kansas City, Kingwood, Kissimmee, Lake Jackson, Lancaster, Las Vegas, Lexington, Liberty, Little Rock, Los Angeles, Lubbock, Lynchburg, Mandeville, Marrero, Maspeth, Mesquite, Metairie, Miami, Monroe, Morristown, Murrieta, New Albany, New Haven, New Iberia, New York, Norman, Orlando, Oxnard, Palmetto Bay, Peoria, Philadelphia, Pittsburgh, Portland, Providence, Raleigh, Richmond, Sacramento, San Antonio, San Diego, Sandy Springs, Santa Maria, Scottsdale, Snellville, Somers Point, Southlake, Sparta, Springboro, Suwanee, Tampa, Tarzana, The Bronx, Thousand Oaks, Toledo, Tomball, Tucson, Tyler, Valencia, Vancouver, Victorville, Waterloo, West Columbia, West Jordan, Westlake, Worcester, and Wyoming, United StatesSee the 120 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: NCT07184996, who can take part
Where in United States
- FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027Arcadia, United StatesTaking people
- 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 StatesNot yet recruiting
- 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
- ChesterfieldChesterfield, United StatesTaking people
- Rush University Medical Center-Site Number: 8400015Chicago, United StatesTaking people
- Novum Research, LLC-Site Number: 8400003Clermont, United StatesTaking people
- Iowa Digestive Disease Center - Site Number: 8400134Clive, United StatesTaking people
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Colorado Springs, United StatesTaking people
- Ohio Gastroenterology Group Inc.-Site Number: 8400006Columbus, United StatesTaking people
- OSU Wexner Medical Center-Site Number: 8400077Columbus, United StatesTaking people
- Precision Clinical Research-Site Number: 8400059Coral Springs, 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, LLC - 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
- Plains Medical Clinic - 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-Ocala - Site Number: 8400048Gainesville, United StatesTaking people
- GI Alliance - Glenview-Site Number: 8400068Glenview, United StatesTaking people
- Mid-Atlantic GI Research, LLC - Site Number: 8400106Greenbelt, United StatesTaking people
- Illinois Gastroenterology Group d/b/a 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
- One of a Kind Clinical Research Center LLC - Texas - 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
- 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
- TLC Clinical Research Inc.-Site Number: 8400030Los Angeles, United StatesTaking people
- Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092Lubbock, United StatesTaking people
- Blue Ridge Medical Research-Site Number: 8400020Lynchburg, United StatesTaking people
- MandevilleMandeville, 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
- Bio Research Partner - 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
- Delta Research PartnersMonroe, United StatesTaking people
- Monroe Biomedical Research-Site Number: 8400046Monroe, United StatesTaking people
- Atlantic Health System, Morristown Medical Center-Site Number: 400137Morristown, United StatesTaking people
- United Medical Doctors CA-Site Number: 8400044Murrieta, United StatesTaking people
- Gastroenterology Health Partners, PLLC - 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
- Lenox Hill Hospital-Site Number: 8400052New 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 Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040New York, United StatesTaking people
- Central Sooner Research-Site Number: 8400094Norman, 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, Center for Health and Healing 2 - Site Number: 8400131Portland, United StatesTaking people
- University Gastroenterology - GI Alliance-Site Number: 8400103Providence, United StatesTaking people
- ClinTrial Research, LLC-Site Number: 8400043Raleigh, 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
- Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025Santa Maria, United StatesTaking people
- One of a Kind Clinical Research Center 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: 840050Somers Point, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101Southlake, United StatesTaking people
- Premier Health Research, LLC-Site Number: 8400114Sparta, United StatesTaking people
- DSI Research, LLC - Site Number: 8400105Springboro, 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
- Cedar Valley Digestive Health Center - Site Number: 8400096Waterloo, United StatesTaking people
- Biocentric Health Research PartnerWest Columbia, 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
- NCT07184996
- Record updated
- 23 October 2026
- Original description
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). 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 Ulcerative Colitis.
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:
The study duration may be up to 35 weeks with:
* 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) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)
The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
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 UC for at least 3 months prior to Baseline; Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies.
Exclusion: Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections; Prior or current high-grade gastrointestinal (GI) dysplasia; Participants on treatment with but not on stable doses of conventional therapies prior to baseline; Participants with prohibited medications or therapies prior to baseline; 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 Crohn's Disease (CD), indeterminate colitis; Current diagnosis of Ulcerative Proctitis.