Duvakitug maintenance treatment for moderately to severely active Crohn's disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 maintenance trial for participants who achieved clinical response and completed endoscopy in the prior STARSCAPE‑1 induction study. Participants are randomized to duvakitug or placebo for a 40-week pivotal maintenance sub-study and may enter a 240-week open-label extension, for a program lasting up to 286 weeks including follow-up. The protocol includes frequent on-site visits (up to 21 visits in the maintenance phase and 22 in the extension) to monitor symptoms, endoscopy findings, and safety. The study’s primary goals are to determine whether duvakitug sustains clinical response and to collect long-term safety data.

Why it matters

Who can join: the full rules

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

Where it's running

• Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
  Colorado Springs, Colorado, United States Recruiting
• Clinical Research of Osceola-Site Number: 8400013
  Kissimmee, Florida, United States Recruiting
• Columbus Clinical Services LLc-Site Number: 8400038
  Miami, Florida, United States Recruiting
• Bioresearch Partner-Kendale Lakes-Site Number: 8400053
  Miami, Florida, United States Recruiting
• Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
  Orlando, Florida, United States Recruiting
• NMC Research LLC-Site Number: 8400033
  Tampa, Florida, United States Recruiting

+59 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.