Zeposia failed to meet the efficacy endpoints in patients with Crohn's disease
Bristol Myers Squibb has provided an update on the progress of the initial Phase 3 YELLOWSTONE trial, which assesses the effectiveness of oral Zeposia (ozanimod) in adult patients suffering from moderate to severe active Crohn’s disease. The analysis of the first of two induction studies revealed that the trial did not achieve its primary objective of achieving clinical remission by Week 12.
The safety profile observed during this study remained consistent with previous trials involving Zeposia. Bristol Myers Squibb intends to conduct a comprehensive review of the YELLOWSTONE trial data and collaborate with investigators to disseminate the findings within the scientific community at a later date.
YELLOWSTONE constitutes a Phase 3, multicenter clinical trial initiative comprising two 12-week induction studies, a 52-week maintenance study, and a 264-week open-label extension study. Its aim is to assess the safety and efficacy of orally administered Zeposia in Crohn’s disease patients compared to a placebo. Each of the induction studies involves approximately 600 patients, with responders advancing to the maintenance study phase. Nonresponders, individuals experiencing disease relapse during maintenance, and those who complete the maintenance study have the opportunity to enroll in the open-label extension trial. Patients enrolled in the trial program receive Zeposia at a dosage of 0.92 mg (equivalent to 1 mg).
The primary objective of the induction studies is to determine the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score of less than 150. Meanwhile, the co-primary endpoints of the maintenance study involve assessing the percentage of patients achieving a CDAI score of less than 150 and those achieving a decrease in Simple Endoscopic Score for Crohn’s disease (SES-CD) of at least 50% from baseline.