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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis · Sponsor: Sanofi
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
Always discuss trial participation with your own doctor first.
Locations (46)
| 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 |
| Royal Palm Clinical Research - Site Number: 8400065 | Fort Myers, Florida, United States | Recruiting |
| Clinical Research of Osceola - Site Number: 8400013 | Kissimmee, Florida, United States | Recruiting |
| Bioresearch Partner-Kendale Lakes - Site Number: 8400053 | Miami, Florida, United States | Recruiting |
| NMC Research LLC - Site Number: 8400033 | Tampa, Florida, United States | Recruiting |
| Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100 | New Albany, Indiana, United States | Recruiting |
| GI Alliance - Baton Rouge - Site Number: 8400129 | Baton Rouge, Louisiana, United States | Recruiting |
| Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128 | Mandeville, Louisiana, United States | Recruiting |
+ 34 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07185009