NCT01628393

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ozanimod	Oral capsule taken once a day
DRUG	Placebo	Oral capsule taken once a day

Timeline

• Start date: 2012-09-18
• Primary completion: 2014-04-13
• Completion: 2016-05-11
• First posted: 2012-06-26
• Last updated: 2021-02-11
• Results posted: 2021-02-11

Locations

58 sites across 13 countries: United States, Belgium, Bulgaria, Georgia, Greece, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Ukraine