An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Study on the Efficacy and Safety of Investigational Medication in Moderately to Severely Active Crohn's Disease

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

Study Overview

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.

Eligibility Criteria

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

  • Conditions: Crohn's Disease
  • 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 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 Criteria:

  • 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
  • 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.

This study investigates how participants with moderately to severely active Crohn's Disease respond to an investigational medication.

The purpose of this study is to assess the safety and effectiveness of the investigational medication. It focuses on understanding its impact on those with moderately to severely active Crohn's Disease.

  • Who can participate: Participants aged 16 to 80 years with moderately to severely active Crohn's Disease can join. They must have tried other therapies without success.
  • Study details: Participants will either receive the investigational medication or a placebo. A placebo 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 8 visits for Sub-Study 1 and Sub-Study 2, and 15 visits for Sub-Study 3.
Updated on 30 Jun 2026. Study ID: NCT07184931

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