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

Study on Efficacy and Safety of Investigational Medication in Ulcerative Colitis

Recruiting
16 years - 80 years
All
Phase 3
980 participants needed
92 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: 16 years - 80 years
  • Gender: All

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.

This study investigates how an investigational medication might work for people with ulcerative colitis.

The purpose of this study is to evaluate the efficacy and safety of the investigational medication. It focuses on how well the medication works and how safe it is for participants.

  • Who can participate: Participants aged 16 to 80 years with moderately to severely active ulcerative colitis can join. They should have had the condition for at least 3 months and not responded well to other treatments.
  • Study details: Participants will take part in different sub-studies lasting up to 12 weeks each. Some may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last up to 35 weeks. The study requires up to 8 visits for Sub-Study 1 and 2, or a maximum of 15 visits for extended induction.
Updated on 23 Apr 2026. Study ID: NCT07184996

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