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

Study on the Efficacy and Safety of an Investigational Medication in Ulcerative Colitis (A Condition Causing Inflammation and Ulcers in the Colon and Rectum)

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

Study Overview

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including:

  • 40-week Pivotal Maintenance Sub-Study
  • 240-week Open-Label Extension (OLE) Sub-Study
  • 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

  • 40 weeks in Pivotal Maintenance Sub-Study
  • 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

  • 21 visits in the Pivotal Maintenance Sub-Study.
  • 11 visits in the OLE Sub-Study.

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 Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
  • Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
  • OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria:

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

This study investigates the efficacy and safety of an investigational medication in people with moderately to severely active Ulcerative Colitis (UC). Ulcerative Colitis is a long-term condition that causes inflammation and ulcers in the digestive tract, specifically the colon and rectum.

Participants in this study will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study includes a maintenance period and an open-label extension where all participants receive the investigational medication.

  • Who can participate: Participants aged 18 to 80 years with moderately to severely active Ulcerative Colitis who have completed previous related studies are eligible. Those with hypersensitivity to the investigational medication or certain medical conditions may be excluded.
  • Study details: Participants will be involved in a randomized, double-blind study where they may receive either the investigational medication or a placebo. The study includes a maintenance period and an open-label extension.
  • Study timelines and visits: The study will last 286 weeks. The study requires 32 visits.
Updated on 02 Oct 2025. Study ID: NCT07185009

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