MSFrontier

SUNBEAM

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
CompletedPhase 3Relapsing MSNCT022940582014-002320-27

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Adjusted Annualized Relapse Rate (ARR) During the Treatment PeriodRate Ratio 0.5180.405–0.663<0.0001
Adjusted Annualized Relapse Rate (ARR) During the Treatment PeriodRate Ratio 0.6880.547–0.8640.0013

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Ozanimod

    Sphingosine 1-phosphate receptor 5 modulator

Compared with

Placebo or sham

  • Placebo to ozanimod
  • Placebo to interferon beta-1a

Results by group

Adjusted Annualized Relapse Rate (ARR) During the Treatment Period

12 months

GroupValueIntervalNumber analysed
Interferon Beta-1a0.350 relapses/year0.279–0.44448
Ozanimod 0.5 mg0.241 relapses/year0.188–0.308451
Ozanimod 1 mg0.181 relapses/year0.14–0.236447

Interferon Beta-1a

0.35

Ozanimod 0.5 mg

0.241

Ozanimod 1 mg

0.181

p = <0.0001; Rate Ratio 0.518 (95% CI 0.405–0.663)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Interferon Beta-1a44511 (2.5%)
Ozanimod 0.5 mg45316 (3.5%)
Ozanimod 1 mg44813 (2.9%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Adjusted Annualized Relapse Rate (ARR) During the Treatment Period

    12 months

    Disability progressionRelapsesMRI lesions

Other measures (11)

  • Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months

    12 month treatment period; MRI scans were assessed at Month 6 and Month 12

    MRI lesions

  • Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12

    Month 12

    MRI lesions

  • Time to Onset of Disability Progression Confirmed After 3 Months

    From first dose to the end of the 12-month treatment period

    Disability progressionWalking and mobilityBladder, bowel and sexual function

  • Time to Onset of Disability Progression Confirmed After 6 Months

    From first dose to the end of the 12-month treatment period

    Disability progressionWalking and mobilityBladder, bowel and sexual function

  • Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12

    Month 12

    MRI lesions

  • Percentage of Participants Who Were T2 Lesion-Free at Month 12

    Month 12

    MRI lesions

  • Percent Change From Baseline in Normalized Brain Volume at Month 12

    Baseline to Month 12

    MRI lesionsBrain volume loss

  • Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test

    Baseline to Month 12

    Disability progressionVisionThinking and memoryWalking and mobilityArm and hand function

  • Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores

    Baseline to Month 12

    Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Number of Participants With Treatment Emergent Adverse Events

    From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.

    Safety

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Dec 2014

    2. Main results due

      Dec 2016

    3. Finished

      Dec 2016

    4. Results posted

      Nov 2020

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