Bristol Myers Squibb (BMY) has reported that a Phase 3 study within the YELLOWSTONE clinical trial program, which was evaluating the efficacy of Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease, did not achieve its primary endpoint of clinical remission at Week 12. Despite this outcome, Zeposia’s safety profile remained consistent with the results documented in previous trials.

The YELLOWSTONE clinical trial program is extensive, encompassing two 12-week induction studies, a 52-week maintenance study, and a 264-week open-label extension study, designed to assess the safety and efficacy of Zeposia versus placebo in treating Crohn’s disease. Participants from the induction studies who responded to treatment were qualified to advance to the maintenance study, while non-responders, those experiencing disease relapse during maintenance, and those completing the maintenance phase were given the option to enter the open-label extension trial. All patients in this comprehensive program were administered oral doses of Zeposia 0.92 mg (equivalent to 1 mg).

Roland Chen, MD, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience development at Bristol Myers Squibb, articulated disappointment in not meeting the primary endpoint in the first induction trial. However, he reaffirmed the company’s commitment to advancing science for patients with immune-mediated diseases and expressed gratitude to participating investigators and patients. He highlighted the unmet medical need for new therapies in Crohn’s disease, emphasizing the significance of finding effective treatments that offer symptomatic relief and potential remission.

Crohn’s disease, a chronic inflammatory bowel disease (IBD), affects the digestive tract and may result in swelling or inflammation of the intestines. This condition can severely impair patients’ quality of life, manifesting in symptoms that range from mild to severe and sometimes developing suddenly. With an estimated 12.6 million individuals affected worldwide, the disease may affect any part of the intestinal tract but most commonly occurs in the colon or the ileum.

Individuals living with Crohn’s disease frequently experience episodes of symptom-free remission, which can be interrupted by relapses or disease flares. Additionally, patients with this condition face an increased risk of developing colorectal cancer, further underscoring the critical need for effective treatments.

The forthcoming full evaluation of the YELLOWSTONE trial data and planned discussions with health authorities signal Bristol Myers Squibb’s ongoing efforts to address the challenges associated with Crohn’s disease through innovative therapeutic options. The scientific community eagerly awaits the detailed results, which will be shared at a future medical conference.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.