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

Investigating Effectiveness and Safety of Investigational Medication

Recruiting
16 years - 80 years
All
Phase 3
751 participants needed
22 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 moderately to severely active Crohn's Disease. The purpose of this study is to explore how the investigational medication affects individuals with this condition.

The study evaluates the safety and effectiveness of the investigational medication over a prolonged period. It seeks to understand how participants respond to the treatment.

  • Who can participate: Participants aged 18 to 80 years may join. Those aged 16 to 18 can participate if they meet specific maturity criteria.
  • Study details: Participants will take part in a study that includes an investigational medication and a placebo.
  • Study timelines and visits: The study will last up to 286 weeks for those in the OLE Sub-Study and up to 46 weeks for those not enrolling in it. The study requires up to 43 visits.
Updated on 18 Jun 2026. Study ID: NCT07184944

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