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

Evaluating the Efficacy and Safety of an Investigational Medication in Moderately to Severely Active Ulcerative Colitis

Recruiting
16 years - 80 years
All
Phase 3
671 participants needed
28 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 moderately to severely active ulcerative colitis. It looks at the condition in adults and young people who meet specific criteria.

The study evaluates the effectiveness and safety of the investigational medication. It checks how well participants tolerate the treatment.

  • Who can participate: Participants aged 16 to 80 years old may join. Key eligibility factors include specific health criteria.
  • Study details: Participants may receive an 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 286 weeks. The study requires up to 32 visits.
Updated on 14 Jul 2026. Study ID: NCT07185009

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