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A Multicenter, Multinational, 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
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.
Age
16 - 80 years
Sex
ALL
Healthy Volunteers
No
Royal Palm Clinical Research - Site Number: 8400065
Fort Myers, Florida, United States
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida, United States
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana, United States
BVL Clinical Research - Site Number: 8400005
Liberty, Missouri, United States
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas, United States
Start Date
January 16, 2026
Primary Completion Date
September 21, 2028
Completion Date
April 28, 2033
Last Updated
March 3, 2026
671
ESTIMATED participants
Duvakitug
DRUG
Placebo
DRUG
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610contact-us@sanofi.comLead Sponsor
Sanofi
Collaborators
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07184996