CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,320 enrolled
Drug / intervention
Ozanimod +3 moredrug
Likely dose
Interferon beta-1a 30 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02047734
NCT02047734Phase 3Completed
CompareCT.gov

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

Celgene·interventional·Posted Jan 28, 2014·Updated Feb 11, 2021

In Brief

A Phase 3 clinical trial evaluating Ozanimod, Ozanimod placebo, and 2 other interventions for Relapsing Multiple Sclerosis. Completed, enrolled 1,320 participants across 299 sites in 21 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesBelarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Georgia, Greece, Hungary, Italy, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 28, 2014
Enrollment StartDec 3, 2013
Primary CompletionMar 27, 2017
Study CompletionApr 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.4 years ago

Interventions

Ozanimoddrug

Oral capsule, daily for 24 months

Ozanimod placebodrug

Oral capsule, daily for 24 months

Interferon beta-1adrug

Intramuscular injection, 30 µg, weekly for 24 months

Interferon beta-1a placebodrug

Intramuscular injection, weekly for 24 months