drugset

drugset / Trial / NCT03464097

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

NCT03464097 ↗

Phase 3 Terminated 550 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Timeline

Start: 2018-06-27
Primary completion: 2024-10-03
Completion: 2024-10-03

Outcome

Missed primary endpoint

Stopped (Business): “The study has terminated due to non-safety reasons; Business Objectives have changed.”

registry Ozanimod 0.92 mg / Ozanimod 0.92 mg vs Ozanimod 0.92 mg / Placebo; p = 0.0539 NCT03464097 ↗

registry p = 0.1503; Odds Ratio (OR) 1.51 (95% CI 0.86 to 2.65) NCT03464097 ↗

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	—	Oral

Indications