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
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
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).
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.
Inclusion Criteria:
Exclusion Criteria:
Douglasville, Georgia 30134, United States
Sofia, 1113, Bulgaria
Konstancin-Jeziorna, 05-510, Poland
Plewiska, 62-064, Poland
Podlaskie, 15-402, Poland
Poznan, 60-355, Poland
Poznan, 61-853, Poland
Warminsko-mazurskie, 10-443, Poland
Bratislava, 833 05, Slovakia
KwaZulu-Natal, 4321, South Africa
Chernihiv, 14033, Ukraine
Dnipropetrovsk, 49027, Ukraine
Dnipropetrovsk, 49027, Ukraine
Kharkiv, 61103, Ukraine
Odesa, 65009, Ukraine
Vinnytsia, 21005, Ukraine
Brighton East Sussex, BN2 5BE, United Kingdom