Condition: Crohn's Disease · Sponsor: Sanofi
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
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: 8400018 | Little Rock, Arkansas, United States | Recruiting |
| Kagoshima IBD Gastroenterology Clinic - 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.: 8400030 | Los Angeles, California, United States | Recruiting |
| United Medical Doctors CA-Site Number: 8400044 | Murrieta, California, United States | Recruiting |
| Prospective Research Innovations Inc.: 8400017 | Rancho Cucamonga, California, United States | Recruiting |
| UC Davis Health System-Site Number: 8400071 | Sacramento, California, United States | Recruiting |
| Clinical Applications Laboratories Inc-Site Number: 8400056 | San Diego, California, United States | Recruiting |
+ 289 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07184931