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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02294058




Registration number
NCT02294058
Ethics application status
Date submitted
5/08/2014
Date registered
19/11/2014
Date last updated
25/11/2020

Titles & IDs
Public title
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Scientific title
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
Secondary ID [1] 0 0
2014-002320-27
Secondary ID [2] 0 0
RPC01-301
Universal Trial Number (UTN)
Trial acronym
SUNBEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Treatment: Drugs - Interferon beta-1a
Treatment: Drugs - Placebo to ozanimod
Treatment: Drugs - Placebo to interferon beta-1a

Active comparator: Interferon beta-1a - Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.

Experimental: Ozanimod 0.5 mg - Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Experimental: Ozanimod 1 mg - Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.


Treatment: Drugs: Ozanimod
Capsules for oral administration once a day

Treatment: Drugs: Interferon beta-1a
Administered by intramuscular injection once a week

Treatment: Drugs: Placebo to ozanimod
Matching placebo capsules administered orally once a day

Treatment: Drugs: Placebo to interferon beta-1a
Placebo intramuscular injection once a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months
Timepoint [1] 0 0
12 month treatment period; MRI scans were assessed at Month 6 and Month 12
Secondary outcome [2] 0 0
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Time to Onset of Disability Progression Confirmed After 3 Months
Timepoint [3] 0 0
From first dose to the end of the 12-month treatment period
Secondary outcome [4] 0 0
Time to Onset of Disability Progression Confirmed After 6 Months
Timepoint [4] 0 0
From first dose to the end of the 12-month treatment period
Secondary outcome [5] 0 0
Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12
Timepoint [5] 0 0
Month 12
Secondary outcome [6] 0 0
Percentage of Participants Who Were T2 Lesion-Free at Month 12
Timepoint [6] 0 0
Month 12
Secondary outcome [7] 0 0
Percent Change From Baseline in Normalized Brain Volume at Month 12
Timepoint [7] 0 0
Baseline to Month 12
Secondary outcome [8] 0 0
Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
Timepoint [8] 0 0
Baseline to Month 12
Secondary outcome [9] 0 0
Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
Timepoint [9] 0 0
Baseline to Month 12
Secondary outcome [10] 0 0
Number of Participants With Treatment Emergent Adverse Events
Timepoint [10] 0 0
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.

Eligibility
Key inclusion criteria
* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* EDSS score between 0 and 5.0 at baseline
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Primary progressive multiple sclerosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2016
Sample size
Target
Accrual to date
Final
1346
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Barcelona
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Valencia
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Goteborg
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Stockholm
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Chernihiv
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Dnipropetrovsk
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Ivano Frankivsk
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Kharkiv
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Lviv
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Uzhhorod
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Zaporizhya
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Zaporizhzhia
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Zhytomyr
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Cardiff
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Inverness
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London
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Sheffiled, MD
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Cree B, et al. The RADIANCE and SUNBEAM phase 3 st... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT02294058