NCT02047734

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

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 3
• Study type: Interventional
• Enrollment: 1,320 (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 (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Detailed description

This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record). Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393. Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ozanimod	Oral capsule, daily for 24 months
DRUG	Ozanimod placebo	Oral capsule, daily for 24 months
DRUG	Interferon beta-1a	Intramuscular injection, 30 µg, weekly for 24 months
DRUG	Interferon beta-1a placebo	Intramuscular injection, weekly for 24 months

Timeline

• Start date: 2013-12-03
• Primary completion: 2017-03-27
• Completion: 2017-04-13
• First posted: 2014-01-28
• Last updated: 2021-02-11
• Results posted: 2021-02-11

Locations

299 sites across 21 countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Georgia, Greece, Hungary, Italy, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom