The P-III (YELLOWSTONE) trial assesses the safety & efficacy of Zeposia (0.92mg, oral) vs PBO for treating moderate to severe active Crohn’s Disease. It comprises of two 12wks. induction studies (n=~600 each), a 52wks. maintenance study (includes induction study responders) & a 264wks. extension study (includes non-responders & those who conclude maintenance study)
The induction trial’s 1EP includes patients with a CDAI score of <150 and the maintenance trial’s co-1EPs are patients with a CDAI score of <150 & SES-CD score decrease by at least 50% from baseline
The trial did not achieve clinical remission at wk.12 and showed Zeposia’s consistent safety profile with its previous evaluations. Full assessment is underway
Ref: BMS | Image: BMS
Related News:- BMS Presents Interim Results of Zeposia (ozanimod) in P-III (True North) OLE Study for the Treatment of Active Ulcerative Colitis at ECCO 2022
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