Duvakitug maintenance treatment for moderate-to-severe ulcerative colitis

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 multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance trial enrolls participants who achieved clinical response and completed endoscopy in the prior SUNSCAPE-1 induction study. Participants are randomized to receive duvakitug or matching placebo for a 40-week pivotal maintenance period, and eligible participants may continue into a 240-week open-label extension to collect longer-term safety and efficacy data. The protocol includes regular on-site visits with endoscopic assessment and safety monitoring, totaling up to 32 visits across the maintenance and extension phases. The study's main goals are to determine whether duvakitug sustains clinical response and to characterize its safety during extended use.

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 SUNSCAPE-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 participant's potential participation in a clinical trial.

Where it's running

• Del Sol Research Management, LLC - Site Number: 8400012
  Tucson, Arizona, United States Recruiting
• Southern California GI & Liver Centers - Site Number: 8400062
  Coronado, California, United States Recruiting
• United Medical Doctors CA - Site Number: 8400044
  Murrieta, California, United States Recruiting
• Om Research, LLC - Victorville - Site Number: 8400022
  Victorville, California, United States Recruiting
• 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

+121 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.