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

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

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.

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 Ulcerative Colitis.

Keywords

Ulcerative Colitis, 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 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 CAN'T join 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.

Locations

  • UC Davis Health System - Site Number: 8400071 accepting new patients
    Sacramento California 95817 United States
  • AdventHealth Orlando - Site Number: 8400070 accepting new patients
    Orlando Florida 90067 United States
  • TLC Clinical Research Inc. - Site Number: 8400030 accepting new patients
    Los Angeles California 90048 United States
  • Medical Associates Research Group - Site Number: 8400063 accepting new patients
    San Diego California 92123 United States
  • Valiance Clinical Research - Tarzana - Site Number: 8400023 accepting new patients
    Tarzana California 91356 United States
  • Clinical Applications Laboratories Inc - Site Number: 8400056 accepting new patients
    San Diego California 92103 United States
  • Alliance Research Institute - Site Number: 8400008 accepting new patients
    Canoga Park California 91304 United States
  • Southern California GI & Liver Centers - Site Number: 8400062 accepting new patients
    Coronado California 92118-1408 United States
  • Amicis Research Center-Valencia -Site Number: 8400064 accepting new patients
    Valencia California 91355 United States
  • FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 accepting new patients
    Arcadia California 91006 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT07184996
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 980 study participants
Last Updated
Contact us about this trial