Condition: Crohn's Disease · Sponsor: Merck Sharp & Dohme LLC
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
This description comes directly from the study's public registry record.
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| Digestive Health Specialists ( Site 5064) | Dothan, Alabama, United States | Completed |
| Arizona Arthritis & Rheumatology Research, PC ( Site 5094) | Phoenix, Arizona, United States | Completed |
| GI Alliance - Sun City ( Site 5118) | Sun City, Arizona, United States | Recruiting |
| University of Arizona Clinical and Translational Sciences Research Center ( Site 5111) | Tucson, Arizona, United States | Recruiting |
| University of Arkansas for Medical Sciences ( Site 5147) | Little Rock, Arkansas, United States | Recruiting |
| Clinnova Research ( Site 5110) | Anaheim, California, United States | Recruiting |
| Southern California Research Center ( Site 5044) | Coronado, California, United States | Recruiting |
| Om Research LLC ( Site 5038) | Lancaster, California, United States | Recruiting |
| Cedars Sinai Medical Center ( Site 5080) | Los Angeles, California, United States | Recruiting |
| UCLA Clinical & Translational Research Center (CTRC) ( Site 5116) | Los Angeles, California, United States | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128) | Orange, California, United States | Recruiting |
| Om Research LLC ( Site 5045) | Oxnard, California, United States | Recruiting |
+ 487 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06430801