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

Evaluating How Well It Works and Safety in Crohn's Disease with Investigational Medication

Recruiting
16 years - 80 years
All
Phase 3
751 participants needed
14 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 how well the investigational medication works and how safe it is for people living with Crohn's Disease.

The study focuses on understanding the safety and effectiveness of the investigational medication over time. Researchers are evaluating how the body responds to the medication and any potential side effects.

  • Who can participate: Participants aged 18 to 80 years, or 16 to under 18 years with specific developmental criteria, may join. Key eligibility includes those who have completed a prior related study phase and meet health requirements.
  • Study details: Participants will take the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study involves regular check-ups to monitor health and response to treatment.
  • Study timelines and visits: The study will last up to 286 weeks. The study requires up to 43 visits.
Updated on 13 May 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

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

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