At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 258 enrolled
Drug / intervention
Ozanimod +1 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 3 clinical trial evaluating Ozanimod and Placebo for Relapsing Multiple Sclerosis. Completed, enrolled 258 participants across 58 sites in 13 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesBelgium, Bulgaria, Georgia, Greece, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2012
Primary CompletionApr 2014
Study CompletionMay 2016
TodayJul 2026
First PostedJun 26, 2012
Enrollment StartSep 18, 2012
Primary CompletionApr 13, 2014
Study CompletionMay 11, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.0 years ago
Interventions
Ozanimoddrug
Oral capsule taken once a day
Placebodrug
Oral capsule taken once a day