Condition: Ulcerative Colitis · Sponsor: Sanofi
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
This description comes directly from the study's public registry record.
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.
| Onyx Clinical Research - Site Number: 8400021 | Peoria, Arizona, United States | Recruiting |
| One of a Kind Clinical Research Center LLC - Site Number: 8400061 | Scottsdale, Arizona, United States | Recruiting |
| Del Sol Research Management, LLC - Site Number: 8400012 | Tucson, Arizona, United States | Recruiting |
| Preferred Research Partners - Site Number: 8400018 | Little Rock, Arkansas, United States | Recruiting |
| FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 | Arcadia, California, United States | Recruiting |
| Alliance Research Institute - Site Number: 8400008 | Canoga Park, California, United States | Recruiting |
| Southern California GI & Liver Centers - Site Number: 8400062 | Coronado, California, United States | Recruiting |
| GMC Clinical Research, LLC - Site Number: 8400113 | Folsom, California, United States | Recruiting |
| TLC Clinical Research Inc. - Site Number: 8400030 | Los Angeles, California, United States | Recruiting |
| United Medical Doctors CA - Site Number: 8400044 | Murrieta, California, United States | Recruiting |
| Medical Associates Research Group - Site Number: 8400063 | San Diego, California, United States | Recruiting |
| Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025 | Santa Maria, California, United States | Recruiting |
+ 179 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07184996