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

Investigation of Efficacy and Safety of an Investigational Medication in Ulcerative Colitis

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 individuals with moderately to severely active ulcerative colitis.

Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study involves regular clinic visits where participants will undergo various tests and assessments to monitor their condition and response to treatment.

  • Who can participate: Adults aged 18 to 80 years, and those 16 to 18 years at Tanner stage 5, may participate. Eligibility includes prior clinical response in a study and completion of required endoscopy.
  • Study details: Participants will attend regular clinic visits to receive the investigational medication or placebo and undergo assessments. 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 286 weeks. The study requires 32 visits.
Updated on 02 Oct 2025. Study ID: NCT07185009

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