Phase 3
Completed N=1,346
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT02294058 ↗Enrolled (actual)
1,346
Serious AEs
3.0%
Results posted
Nov 2020
Primary outcomePrimary: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period — 0.350; 0.241; 0.181 relapses/year — p=<0.0001
◆ Published Evidence
Highly cited
286citations · ~41 / year
Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial.
Summary
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
Linked Publications (3)
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Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial.
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Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS.
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Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Annualized Relapse Rate (ARR) During the Treatment Period |
0.350; 0.241; 0.181 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months |
2.836; 2.139; 1.465 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 |
0.433; 0.287; 0.160 | <0.0001 sig |
| SECONDARY Time to Onset of Disability Progression Confirmed After 3 Months |
NA; NA; NA | 0.3055 |
| SECONDARY Time to Onset of Disability Progression Confirmed After 6 Months |
NA; NA; NA | 0.6725 |
| SECONDARY Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12 |
63.17; 68.29; 74.05 | 0.0006 sig |
| SECONDARY Percentage of Participants Who Were T2 Lesion-Free at Month 12 |
23.44; 26.39; 27.96 | 0.1180 |
| SECONDARY Percent Change From Baseline in Normalized Brain Volume at Month 12 |
-0.57; -0.50; -0.39 | <0.0001 sig |
| SECONDARY Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test |
-0.022; -0.007; 0.003 | 0.1290 |
| SECONDARY Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores |
0.046; 1.414; 1.925; -0.123; 0.283; 0.260 | 0.0364 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
336; 259; 268; 182; 113; 138 | — |
Eligibility Criteria
Inclusion Criteria
- Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- EDSS score between 0 and 5.0 at baseline
Exclusion Criteria
- Primary progressive multiple sclerosis
Data sourced from ClinicalTrials.gov (NCT02294058) 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.