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

Study on Efficacy and Safety of Investigational Medication for Crohn's Disease

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

Study Overview

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study
  • 240 weeks in OLE Sub-Study

The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • 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 STARSCAPE-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 patient'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 Crohn's Disease.

The study focuses on evaluating the safety and effectiveness of the investigational medication over a long period. Researchers aim to understand how the treatment impacts symptoms and overall health.

  • Who can participate: Participants aged 16 to 80 years with moderately to severely active Crohn's Disease may join. They must meet specific health criteria.
  • Study details: Participants will assess the investigational medication. The study includes monitoring to ensure safety and gather data.
  • Study timelines and visits: The study will last 286 weeks. The study requires 43 visits.
Updated on 03 Apr 2026. Study ID: NCT07184944

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