Condition: Crohn's Disease · Sponsor: Sanofi
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
This description comes directly from the study's public registry record.
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| 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 |
| 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 |
| Gateway Gastroenterology-Site Number: 8400097 | St Louis, Missouri, United States | Recruiting |
| MedTraits NY-Site Number: 8400045 | Maspeth, New York, United States | Recruiting |
| NYU Langone Health-Site Number: 8400091 | New York, New York, United States | Recruiting |
| Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 | New York, New York, United States | Recruiting |
| New York Gastroenterology Associates-Site Number: 8400009 | New York, New York, United States | Recruiting |
+ 23 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07184944