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RADIANCE

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
CompletedPhase 3Relapsing MSNCT02047734

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Adjusted Annualized Relapse Rate (ARR) at the End of Month 24Rate Ratio 0.6230.506–0.768<0.0001
Adjusted Annualized Relapse Rate (ARR) at the End of Month 24Rate Ratio 0.7910.652–0.9580.0167

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Ozanimod

    Sphingosine 1-phosphate receptor 5 modulator

Compared with

Placebo or sham

  • Ozanimod placebo
  • Interferon beta-1a placebo

Results by group

Adjusted Annualized Relapse Rate (ARR) at the End of Month 24

At the end of month 24

GroupValueIntervalNumber analysed
Interferon Beta-1a0.276 relapses/year0.234–0.324441
Ozanimod 0.5 mg0.218 relapses/year0.183–0.259439
Ozanimod 1 mg0.172 relapses/year0.142–0.208433

Interferon Beta-1a

0.276

Ozanimod 0.5 mg

0.218

Ozanimod 1 mg

0.172

p = <0.0001; Rate Ratio 0.623 (95% CI 0.506–0.768)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Interferon Beta-1a44028 (6.4%)0
Ozanimod 0.5 mg43931 (7.1%)1
Ozanimod 1 mg43428 (6.5%)0

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) at the End of Month 24

    At the end of month 24

    Disability progressionRelapsesMRI lesions

Other measures (10)

  • Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months

    24 month treatment period; MRI scans were performed at Months 12 and 24

    MRI lesions

  • Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24

    Month 24

    MRI lesions

  • Time to Onset of Disability Progression Confirmed After 3 Months

    From first dose to the end of the 24-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 24-month treatment period

    Disability progressionWalking and mobilityBladder, bowel and sexual function

  • Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24

    Month 24

    MRI lesions

  • Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24

    Month 24

    MRI lesions

  • Percent Change From Baseline in Normalized Brain Volume to Month 24

    Baseline and Month 24

    MRI lesionsBrain volume loss

  • Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test

    Baseline to Month 24

    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 24

    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 up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extensio

    Safety

Who could take part

Relapsing MS · 18 to 55

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

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

About this trial

In the sponsor's words

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).

Papers

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Linked trials

  • Refers to

    RADIANCE

    Phase 2 / Phase 3 · Completed

  • Referred to by

    RADIANCE

    Phase 2 / Phase 3 · Completed

Links found where a registry record names another trial's registry number.

Related trials

History

  1. In scope changed from false to true
  2. In scope changed from true to false

  1. Started

    Dec 2013

  2. Main results due

    Mar 2017

  3. Finished

    Apr 2017

  4. Results posted

    Feb 2021

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