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

Recruiting
16 years - 80 years
All
Phase 3
671 participants needed
1 Location

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

Updated on 03 Apr 2026. Study ID: NCT07184944

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language