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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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 Crohn's Disease

Keywords

Crohn's Disease, Crohn Disease, Duvakitug

Eligibility

You can join if…

Open to people ages 16-80

  • 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)

You CAN'T join if...

  • 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.

Locations

  • UC Davis Health System-Site Number: 8400071 accepting new patients
    Sacramento California 95817 United States
  • GMC Clinical Research, LLC-Site Number: 8400113 accepting new patients
    Folsom California 95630 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
EFC18326 Plain Language Results Summary
ID
NCT07184931
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 980 study participants
Last Updated
Contact us about this trial