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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 2Phase 3Relapsing MSNCT016283932012-002714-40

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 <0.0001
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 <0.0001

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

Results by group

Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24

From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24

GroupValueIntervalNumber analysed
Placebo11.1 lesions29.87 (Standard Deviation)88
Ozanimod 0.5 mg1.9 lesions4.77 (Standard Deviation)87
Ozanimod 1 mg1.5 lesions3.44 (Standard Deviation)83

Placebo

11.1

Ozanimod 0.5 mg

1.9

Ozanimod 1 mg

1.5

p = <0.0001

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo-Controlled Period: Placebo880 (0.0%)0
Placebo-Controlled Period: Ozanimod 0.5 mg873 (3.4%)0
Placebo-Controlled Period: Ozanimod 1.0 mg830 (0.0%)0
Extension Period: Ozanimod 0.5 mg12610 (7.9%)0
Extension Period: Ozanimod 1.0 mg1239 (7.3%)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

  • Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24

    From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24

    MRI lesions

  • Primary Efficacy Endpoint:

Other measures (6)

  • The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24

    Week 24

    MRI lesions

  • The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24

    Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24

    MRI lesions

  • Adjusted Annualized Relapse Rate (ARR) at Week 24

    Week 24

    Disability progressionRelapsesMRI lesions

  • Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period

    From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.

    Safety

  • Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure

    From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in

    Safety

  • Secondary Efficacy Endpoints:

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: * Secondary or 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 (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).

Papers

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Linked trials

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

    Sept 2012

  2. Main results due

    Apr 2014

  3. Finished

    May 2016

  4. Results posted

    Feb 2021

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