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NCT07184944
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Conditions: Crohn's Disease
Sex: All
Ages: 16 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 751
Sponsor: Sanofi
Location: Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 Colorado Springs Colorado
Summary
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
Inclusion Criteria:
* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \
Source: ClinicalTrials.gov (NCT07184944). StuddyBuddy aggregates publicly available trial information.