Bristol Myers Squibb Provides Update on the First Phase 3 YELLOWSTONE Trial Evaluating Oral Zeposia (ozanimod) in Patients with Moderate to Severe Active Crohn’s Disease
Bristol Myers Squibb (NYSE: BMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12.
The safety profile of Zeposia in this study was consistent with that observed in previously reported trials. The company will complete a full evaluation of the YELLOWSTONE trial data and work with investigators to share the results with the scientific community in the future.
“To date, no S1P modulator has shown an effect in a Phase 3 trial in Crohn’s disease, where a high unmet medical need remains for new therapies that offer more patients relief from symptoms and the potential for remission,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “While we are disappointed that the primary endpoint was not reached in this first induction trial, we are committed to driving transformative science on behalf of individuals with immune-mediated diseases and would like to thank the investigators and patients who are participating in the YELLOWSTONE clinical trial program.”
About the YELLOWSTONE Clinical Trial Program
YELLOWSTONE is a Phase 3, multicenter clinical trial program consisting of two 12-week induction studies, a 52-week maintenance study and a 264-week open-label extension study. YELLOWSTONE is designed to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with Crohn’s disease versus placebo. The induction studies include approximately 600 patients each, with responders moving on to participate in the maintenance study. Nonresponders, those with disease relapse during maintenance, and completers of the maintenance study have the option to enroll in the open-label extension trial. Patients in the trial program are receiving Zeposia 0.92 mg (equivalent to 1 mg).
The primary endpoint of the induction studies is the proportion of patients with a Crohn’s Disease Activity Index (CDAI) score of less than 150. The co-primary endpoints of the maintenance study are the proportion of patients with a CDAI score of less than 150 and the proportion of patients with a Simple Endoscopic Score for Crohn’s disease (SES-CD) score decrease from baseline of at least 50%.
April 1, 2024
