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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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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Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether ozanimod is effective in the treatment of
relapsing multiple sclerosis (RMS).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02294058
Trial related presentations / publications
Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Ding N, Cohen JA; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1009-1020. doi: 10.1016/S1474-4422(19)30239-X. Epub 2019 Sep 3.
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