Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Phase 3 Completed 606 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Timeline

Start: 2018-03-07
Primary completion: 2023-11-21
Completion: 2023-11-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Ozanimod vs Placebo; p = 0.8125; Odds Ratio (OR) 0.96 (95% CI 0.66 to 1.39); Cochran-Mantel-Haenszel NCT03440385 ↗

Publications

Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ozanimod	Small molecule	0.92 mg	Oral