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Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047734
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS). The study is a two-part trial (Part A and B), phase 2/3, with Part A (NCT01628393) consisting of a placebo-controlled phase and optional extension period and Part B (NCT02047734) as an active-controlled study. Part B is presented within this record.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Ozanimod 0.5 mg Drug: Ozanimod 1 mg Drug: Ozanimod placebo Drug: Interferon β-1a Drug: IFN β-1a placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2013
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : April 13, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ozanimod 0.5 mg
Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
 Drug: Ozanimod 0.5 mg
Oral capsule, daily for 24 months
Other Name: RPC1063

Drug: IFN β-1a placebo
Intramuscular injection, weekly for 24 months
Experimental: Ozanimod1 mg
Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
 Drug: Ozanimod 1 mg
Oral capsule, daily for 24 months
Other Name: RPC1063

Drug: IFN β-1a placebo
Intramuscular injection, weekly for 24 months
Active Comparator: Interferon β-1a
Interferon (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months
 Drug: Ozanimod placebo
Oral capsule, daily for 24 months

Drug: Interferon β-1a
Intramuscular injection, 30 µg, weekly for 24 months
Other Name: Avonex


Outcome Measures
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Primary Outcome Measures :
  1. Annualized relapse rate (ARR) at the end of Month 24 [ Time Frame: Month 24 ]
    The relapse rate was based on only relapses that were confirmed by the treating investigator. Any new or recurrent neurological symptoms that occurred less than 30 days following the onset of a protocol defined relapse was considered part of the same relapse, i.e., if 2 relapses have onset days that are <30 days of one another, were counted as 1 relapse with onset date as the earlier of the 2 relapses.


Secondary Outcome Measures :
  1. The number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months [ Time Frame: Up to 24 months ]
    The number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since baseline from Week 12 to Week 24.

  2. The number of GdE brain MRI lesions at Month 24 [ Time Frame: Up to months 24 ]
    The number of Gd-enhancing T1-lesions per MRI scan was measured as the total number of Gd-enhancing T1-lesions that occurred at month 24. Includes participants with non-missing MRI results and included to the analysis population.

  3. Time to onset of disability progression as defined by a sustained worsening in EDSS of 1.0 points or more, confirmed after 3 months and after 6 months [ Time Frame: Up to month 6 ]
    The Expanded Disability Status Scale (EDSS) is an ordinal scale instrument widely accepted to evaluate disability status at a particular time and disability progression over time in patients and MS clinical studies. The disability level is based on a neurological examination to obtain scores in seven neurologic functional systems (FSs) and an ambulation score that are combined to determine the overall EDSS score (step) ranging from 0 (normal) to 10 (death due to MS). The FSs are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral. Ambulation is measured based on if restriction is present and assisted required as well as minimum distance level achieved.

  4. Proportion of patients who are GdE lesion-free at Month 24 [ Time Frame: Up to month 24 ]
    Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions from the date of the first study treatment to their month 24 MRI Scan.

  5. Proportion of patients who are new or enlarging T2 lesion-free at Month 24 [ Time Frame: Month 24 ]
    Participants were considered T2 lesion free at Month 24 if they did not show evidence of a relapse in T2 lesions from the date of the first study treatment to study completion at month 24.

  6. The percent change in normalized brain volume (atrophy) on brain MRI scans from baseline to [ Time Frame: Baseline to month 24 ]
    Brain volumes were reported in cm^3. Atrophy was measured by MRI scan.

  7. Change in MSFC score from Baseline to Month 24 (including the Low-Contrast Letter Acuity [ Time Frame: Up to month 24 ]

    The MSFC-LCLA is a battery including the following 4 individual scales:

    • The Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds
    • The 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function
    • The Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability
    • Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity Z-scores were calculated for the MSFC for each component and averaged to create an overall composite score. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.

  8. Change in MSQOL-54 score from Baseline to Month 24 [ Time Frame: At month 24 ]
    The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each domain has a range from 0 to 100 where higher means better or improved.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047734


Locations
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Sponsors and Collaborators
Celgene
More Information
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Publications of Results:
Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02047734    
Other Study ID Numbers: RPC01-201-PartB
2012-002714-40 ( EudraCT Number )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic