Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Phase 3 Terminated 625 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: 2018-02-27
Primary completion: 2024-10-01
Completion: 2024-10-01

Outcome

Met primary endpoint

Stopped (Business): “Business objectives have changed.”

registry analysis (superiority test); Treatment 1 vs Treatment 2; p = 0.0049; Odds Ratio (OR) 1.79 (95% CI 1.19 to 2.70); Mantel Haenszel NCT03440372 ↗

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