Phase 3
Completed N=258
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
Source: ClinicalTrials.gov NCT01628393 ↗Enrolled (actual)
258
Serious AEs
4.3%
Results posted
Feb 2021
Primary outcomePrimary: Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 — 11.1; 1.9; 1.5 lesions — p=<0.0001
◆ Published Evidence
Highly cited
178citations · ~18 / year
Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial.
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).
Linked Publications (2)
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Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial.
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Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 |
11.1; 1.9; 1.5 | <0.0001 sig |
| SECONDARY The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24 |
3.2; 0.4; 0.2 | <0.0001 sig |
| SECONDARY The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24 |
9.0; 1.4; 0.8 | <0.0001 sig |
| SECONDARY Adjusted Annualized Relapse Rate (ARR) at Week 24 |
0.50; 0.35; 0.24 | 0.0531 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period |
52; 57; 47; 23; 23; 13 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure |
26; 73; 32; 61; 17; 42 | — |
Eligibility Criteria
Inclusion Criteria
- Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline
Exclusion Criteria
- Secondary or primary progressive multiple sclerosis
Data sourced from ClinicalTrials.gov (NCT01628393) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.