Contemporary clinical trials · 11 authors, 8 centres
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The YELLOWSTONE program describes the design of phase 3 randomized, double-blind, placebo-controlled trials evaluating the oral drug ozanimod for inducing and maintaining remission in adults with moderately to severely active Crohn's disease. The trials aim to confirm the efficacy and safety suggested by prior phase 2 results.
This paper describes the design of the YELLOWSTONE phase 3 clinical trial program for ozanimod in Crohn's disease (CD). The program includes randomized, double-blind, placebo-controlled induction (12 weeks) and maintenance (52 weeks) studies, followed by an open-label extension. The primary focus is on the trial methodology rather than completed efficacy or safety outcomes. The design emphasizes the use of centrally read endoscopic endpoints (SES-CD) and histologic assessments to reduce bias and improve objective measurement. It also uses the Crohn's Disease Activity Index (CDAI) for symptom control. The discussion highlights the potential for ozanimod to address the unmet need for safe, oral, durable therapies in CD, building on positive phase 2 results and its approved use in ulcerative colitis. Limitations are inherent to a trial design paper; no completed data on efficacy or safety are reported.
