YELLOWSTONE: Ozanimod Misses Primary Endpoint in Crohn Disease Study

A phase 3 trial evaluating ozanimod, a sphingosine 1-phosphate (S1P) receptor modulator, in patients with moderate to severe Crohn disease (CD) did not meet its primary endpoint, according to Bristol Myers Squibb.

The YELLOWSTONE clinical development program includes two 12-week double-blind, placebo-controlled induction studies that each enrolled approximately 600 patients with Crohn disease (Crohn Disease Activity Index [CDAI] score ≥220 and ≤450). Study participants were randomly assigned to receive ozanimod 0.92mg (equivalent to 1mg) or placebo. The primary endpoint was clinical remission, defined as a CDAI score of less than 150 at week 12.

Results from the first induction study (ClinicalTrials.gov Identifier: NCT03440372) showed no statistically significant difference in clinical remission between the ozanimod and placebo groups. The safety profile of ozanimod was reported to be consistent with what has been previously observed in other clinical trials.

“To date, no S1P modulator has shown an effect in a phase 3 trial in Crohn 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.”

Ozanimod is currently marketed under the brand name Zeposia^® for the treatment of relapsing forms of multiple sclerosis and moderately to severely active ulcerative colitis.