Phase 3
Completed N=1,320
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT02047734 ↗Enrolled (actual)
1,320
Serious AEs
6.6%
Results posted
Feb 2021
Primary outcomePrimary: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 — 0.276; 0.218; 0.172 relapses/year — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 |
0.276; 0.218; 0.172 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months |
3.183; 2.092; 1.835 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 |
0.373; 0.197; 0.176 | 0.0006 sig |
| SECONDARY Time to Onset of Disability Progression Confirmed After 3 Months |
NA; NA; NA | 0.8224 |
| SECONDARY Time to Onset of Disability Progression Confirmed After 6 Months |
NA; NA; NA | 0.1353 |
| SECONDARY Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24 |
56.2; 63.3; 65.6 | 0.0047 sig |
| SECONDARY Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24 |
18.4; 23.5; 23.8 | 0.0466 sig |
| SECONDARY Percent Change From Baseline in Normalized Brain Volume to Month 24 |
-0.937; -0.707; -0.707 | <0.0001 sig |
| SECONDARY Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test |
-0.052; 0.036; -0.010 | 0.2480 |
| SECONDARY Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores |
-1.526; 0.609; 0.209; -1.831; -1.182; -1.517 | 0.0988 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
365; 326; 324; 235; 169; 170 | — |
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
- Primary progressive multiple sclerosis
Data sourced from ClinicalTrials.gov (NCT02047734). 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.