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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT07184996

Run by

Sanofi

People needed

980

Starts

2025-10-08

Expected to finish

2028-05-09

Last updated by the study team

2026-04-24

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• One of a Kind Clinical Research Center LLC - Site Number: 8400061 — Scottsdale, Arizona, United States (enrolling)
• Del Sol Research Management, LLC - Site Number: 8400012 — Tucson, Arizona, United States (enrolling)
• Preferred Research Partners - Site Number: 8400018 — Little Rock, Arkansas, United States (enrolling)
• FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 — Arcadia, California, United States (enrolling)
• Alliance Research Institute - Site Number: 8400008 — Canoga Park, California, United States (enrolling)
• Southern California GI & Liver Centers - Site Number: 8400062 — Coronado, California, United States (enrolling)
• GMC Clinical Research, LLC - Site Number: 8400113 — Folsom, California, United States (enrolling)
• TLC Clinical Research Inc. - Site Number: 8400030 — Los Angeles, California, United States (enrolling)
• United Medical Doctors CA - Site Number: 8400044 — Murrieta, California, United States (enrolling)
• Medical Associates Research Group - Site Number: 8400063 — San Diego, California, United States (enrolling)
• Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025 — Santa Maria, California, United States (enrolling)
• Valiance Clinical Research - Tarzana - Site Number: 8400023 — Tarzana, California, United States (enrolling)
• Clinical Trials Management Services - Site Number: 8400047 — Thousand Oaks, California, United States (enrolling)
• Amicis Research Center-Valencia -Site Number: 8400064 — Valencia, California, United States (enrolling)
• Om Research, LLC - Victorville - Site Number: 8400022 — Victorville, California, United States (enrolling)
• Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs, Colorado, United States (enrolling)
• Gastroenterology of the Rockies - Denver - Site Number: 8400122 — Denver, Colorado, United States (enrolling)
• Novum Research, LLC - Site Number: 8400003 — Clermont, Florida, United States (enrolling)
• Precision Clinical Research-Site Number: 8400059 — Coral Springs, Florida, United States (enrolling)
• Sarkis Clinical Trials-Ocala - Site Number: 8400048 — Gainesville, Florida, United States (enrolling)
• Clinical Research of Osceola - Site Number: 8400013 — Kissimmee, Florida, United States (enrolling)
• Columbus Clinical Services LLc - Site Number: 8400038 — Miami, Florida, United States (enrolling)
• Regis Clinical Research, LLC - Site Number: 8400041 — Miami, Florida, United States (enrolling)
• Bio Research Partner - Site Number: 8400053 — Miami, Florida, United States (enrolling)
• Onyx Clinical Research - Site Number: 8400021 — Peoria, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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