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Bored Studies
RecruitingPhase 3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Sanofi · with Teva Branded Pharmaceutical Products R&D LLC · NCT07184996

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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
119
Study start
October 8, 2025
Record last updated
October 23, 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 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.

Being studied: Duvakitug; Placebo

Conditions: Ulcerative Colitis

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 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 Criteria

  • Participants with Crohn's Disease (CD), indeterminate colitis
  • Current diagnosis of Ulcerative Proctitis
  • 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.

Recruiting US locations

  • Onyx Clinical Research - Site Number: 8400021

    Peoria, AZ 85381

  • One of a Kind Clinical Research Center 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

  • FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027

    Arcadia, CA 91006

  • Alliance Research Institute - Site Number: 8400008

    Canoga Park, CA 91304

  • Southern California GI & Liver Centers - Site Number: 8400062

    Coronado, CA 92118-1408

  • 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

  • United Medical Doctors CA - Site Number: 8400044

    Murrieta, CA 92563

  • Om Research, LLC - Oxnard - Site Number: 8400150

    Oxnard, CA 93030

  • 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

  • Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025

    Santa Maria, CA 93458

  • 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 32803

  • Precision Clinical Research-Site Number: 8400059

    Coral Springs, FL 33065

  • Sarkis Clinical Trials-Ocala - 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

  • Bio Research Partner - Site Number: 8400053

    Miami, FL 33155

  • Medical Professional Clinical Research Center - Site Number: 8400119

    Miami, FL 33165

  • Paradisus Med Research - Site Number: 8400036

    Miami, FL 33185

  • Correa Research Center-Site Number: 8400010

    Miami, FL 33186

  • Orlando Health, Inc. - Site Number: 8400084

    Orlando, FL 32806

  • AdventHealth Orlando - Site Number: 8400070

    Orlando, FL 90067

  • Tropical Clinical Trials - Site Number: 8400082

    Palmetto Bay, FL 33176

  • 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

  • Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049

    Gurnee, IL 60031

  • Gastroenterology Health Partners, PLLC - Site Number: 8400100

    New Albany, IN 47150

  • Iowa Digestive Disease Center - Site Number: 8400134

    Clive, IA 50325

  • Cedar Valley Digestive Health 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 70072

  • GastroGroup - 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

  • Delta Research Partners

    Monroe, LA 71291

+ 59 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