← Back to all trials
Recruiting
NCT07185009
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Conditions: Ulcerative Colitis
Sex: All
Ages: 16 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 671
Sponsor: Sanofi
Location: Del Sol Research Management, LLC - Site Number: 8400012 Tucson Arizona
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
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 Pivotal Maintenance Sub-Study
* 240 weeks in OLE Sub-Study
The total number of on-site visit will be up to 32:
* 21 visits in the Pivotal Maintenance Sub-Study.
* 11 visits in the OLE Sub-Study.
Eligibility Criteria
Inclusion Criteria:
* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \
Source: ClinicalTrials.gov (NCT07185009). StuddyBuddy aggregates publicly available trial information.