Trial Outcomes & Findings for Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) (NCT NCT02294058)

Last Updated: 2020-11-25

Results Overview

The relapse rate was based on confirmed relapses. A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of relapses divided by the total number of days in the study \* 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1346 participants

Primary outcome timeframe

12 months

Results posted on

2020-11-25

Participant Flow

The study was conducted at 152 sites in 20 countries in Eastern and Western Europe, the United States, and New Zealand. Between December 2014 and November 2015, 1656 participants were screened, of whom 1346 were eligible and enrolled.

Participants were randomly assigned to one of three treatment groups in a 1:1:1 ratio. Randomization was stratified by Baseline Expanded Disability Status Scale (EDSS) score (≤ 3.5, \> 3.5) and country.

Participant milestones

Participant milestones
Measure	Interferon Beta-1a Participants received 30 µg interferon beta-1a (IFN β-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 at least 12 months.	Ozanimod 0.5 mg Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.
Overall Study STARTED	448	451	447
Overall Study Safety Population	445	453	448
Overall Study COMPLETED	412	425	418
Overall Study NOT COMPLETED	36	26	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Interferon Beta-1a Participants received 30 µg interferon beta-1a (IFN β-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 at least 12 months.	Ozanimod 0.5 mg Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.
Overall Study Adverse Event	16	7	13
Overall Study Lack of Efficacy	3	3	0
Overall Study Lost to Follow-up	1	0	2
Overall Study Withdrawal by Subject	10	14	13
Overall Study Physician Decision	2	1	0
Overall Study Miscellaneous	4	1	1

Baseline Characteristics

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Total n=1346 Participants Total of all reporting groups
Age, Continuous	35.9 years STANDARD_DEVIATION 9.11 • n=5 Participants	36.0 years STANDARD_DEVIATION 9.43 • n=7 Participants	34.8 years STANDARD_DEVIATION 9.24 • n=5 Participants	35.6 years STANDARD_DEVIATION 9.27 • n=4 Participants
Sex: Female, Male Female	300 Participants n=5 Participants	311 Participants n=7 Participants	283 Participants n=5 Participants	894 Participants n=4 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	140 Participants n=7 Participants	164 Participants n=5 Participants	452 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	447 Participants n=5 Participants	447 Participants n=7 Participants	446 Participants n=5 Participants	1340 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region Rest of World	29 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	93 Participants n=4 Participants
Region Eastern Europe	419 Participants n=5 Participants	419 Participants n=7 Participants	415 Participants n=5 Participants	1253 Participants n=4 Participants
Expanded Disability Status Scale (EDSS)	2.62 units on a scale STANDARD_DEVIATION 1.138 • n=5 Participants	2.65 units on a scale STANDARD_DEVIATION 1.135 • n=7 Participants	2.61 units on a scale STANDARD_DEVIATION 1.160 • n=5 Participants	2.62 units on a scale STANDARD_DEVIATION 1.144 • n=4 Participants
Time Since MS Symptom Onset	6.88 years STANDARD_DEVIATION 5.877 • n=5 Participants	7.16 years STANDARD_DEVIATION 6.255 • n=7 Participants	6.85 years STANDARD_DEVIATION 6.449 • n=5 Participants	6.96 years STANDARD_DEVIATION 6.195 • n=4 Participants
Time Since MS Diagnosis	3.71 years STANDARD_DEVIATION 4.361 • n=5 Participants	3.70 years STANDARD_DEVIATION 4.518 • n=7 Participants	3.60 years STANDARD_DEVIATION 4.193 • n=5 Participants	3.67 years STANDARD_DEVIATION 4.357 • n=4 Participants
Age at MS Symptom Onset	29.5 years STANDARD_DEVIATION 8.92 • n=5 Participants	29.3 years STANDARD_DEVIATION 9.25 • n=7 Participants	28.4 years STANDARD_DEVIATION 8.42 • n=5 Participants	29.1 years STANDARD_DEVIATION 8.88 • n=4 Participants
Age at MS Diagnosis	32.7 years STANDARD_DEVIATION 9.01 • n=5 Participants	32.7 years STANDARD_DEVIATION 9.49 • n=7 Participants	31.6 years STANDARD_DEVIATION 8.81 • n=5 Participants	32.4 years STANDARD_DEVIATION 9.12 • n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The ITT population consisted of all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period	0.350 relapses/year Interval 0.279 to 0.44	0.241 relapses/year Interval 0.188 to 0.308	0.181 relapses/year Interval 0.14 to 0.236

SECONDARY outcome

Timeframe: 12 month treatment period; MRI scans were assessed at Month 6 and Month 12

Population: ITT population; participants with non-missing MRI results.

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 over treatment period.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=382 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=397 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=388 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months	2.836 T2 lesions/scan Interval 2.331 to 3.451	2.139 T2 lesions/scan Interval 1.777 to 2.575	1.465 T2 lesions/scan Interval 1.203 to 1.784

SECONDARY outcome

Timeframe: Month 12

Population: ITT population; participants with non-missing MRI results.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=382 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=397 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=388 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12	0.433 lesions Interval 0.295 to 0.635	0.287 lesions Interval 0.197 to 0.418	0.160 lesions Interval 0.106 to 0.242

SECONDARY outcome

Timeframe: From first dose to the end of the 12-month treatment period

Population: ITT population

EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present. The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments. Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Time to Onset of Disability Progression Confirmed After 3 Months	NA days Not estimable as there were insufficient disability events	NA days Not estimable as there were insufficient disability events	NA days Not estimable as there were insufficient disability events

SECONDARY outcome

Timeframe: From first dose to the end of the 12-month treatment period

Population: ITT population

EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present. The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments. Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 6 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Time to Onset of Disability Progression Confirmed After 6 Months	NA days Not estimable as there were insufficient disability events	NA days Not estimable as there were insufficient disability events	NA days Not estimable as there were insufficient disability events

SECONDARY outcome

Timeframe: Month 12

Population: The ITT population; Participants who were missing the Month 12 MRI data were considered non-responders; ie, as not being lesion-free (non-responder imputation).

MRI scans were analyzed by blinded centralized reading facility.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12	63.17 percentage of participants Interval 58.7 to 67.64	68.29 percentage of participants Interval 64.0 to 72.59	74.05 percentage of participants Interval 69.99 to 78.11

SECONDARY outcome

Timeframe: Month 12

Population: The ITT population; participants who were missing the Month 12 MRI data were considered non-responders, ie, as not being lesion-free.

MRI scans were analyzed by blinded centralized reading facility.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Percentage of Participants Who Were T2 Lesion-Free at Month 12	23.44 percentage of participants Interval 19.51 to 27.36	26.39 percentage of participants Interval 22.32 to 30.45	27.96 percentage of participants Interval 23.8 to 32.12

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: The ITT population with available MRI data at Baseline and Month 12

Brain volume (a measure of brain atrophy) was analyzed by MRI.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=334 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=347 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=338 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Percent Change From Baseline in Normalized Brain Volume at Month 12	-0.57 percent change Interval -3.7 to 1.1	-0.50 percent change Interval -2.7 to 1.4	-0.39 percent change Interval -2.8 to 2.1

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: The ITT population with available Baseline and Month 12 MSFC z-scores.

The MSFC-LCLA is a battery including the following 4 individual scales: * Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds * 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function * 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, charts are scored according to the number of letters that are identified correctly Z-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A z-score represents the number of standard deviations a patient's test result is higher (z \> 0) or lower (z \< 0) than the average test result (z = 0) of the reference population. A positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=447 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=450 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=447 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test	-0.022 z-score Standard Deviation 0.334	-0.007 z-score Standard Deviation 0.351	0.003 z-score Standard Deviation 0.328

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: ITT population with available Baseline data; missing post-baseline data were imputed using a mixed-effects regression model (random slope and intercept).

The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures. The two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. The physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress. The mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function. Each composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=448 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=451 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=446 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores Physical health composite summary	0.046 units on a scale Standard Deviation 12.578	1.414 units on a scale Standard Deviation 12.343	1.925 units on a scale Standard Deviation 11.870
Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores Mental health composite summary	-0.123 units on a scale Standard Deviation 15.240	0.283 units on a scale Standard Deviation 15.686	0.260 units on a scale Standard Deviation 15.800

SECONDARY outcome

Timeframe: 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.

Population: Safety Population consisted of all participants who received at least 1 dose of randomized study medication, analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.

An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.

Outcome measures

Outcome measures
Measure	Interferon Beta-1a n=445 Participants Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=453 Participants Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=448 Participants Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
Number of Participants With Treatment Emergent Adverse Events Any TEAE	336 Participants	259 Participants	268 Participants
Number of Participants With Treatment Emergent Adverse Events Any Moderate or Severe TEAE	182 Participants	113 Participants	138 Participants
Number of Participants With Treatment Emergent Adverse Events Any Severe TEAE	10 Participants	10 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events Any Suspected TEAE	83 Participants	76 Participants	91 Participants
Number of Participants With Treatment Emergent Adverse Events Any Serious TEAE	11 Participants	16 Participants	13 Participants
Number of Participants With Treatment Emergent Adverse Events Any Suspected Serious TEAE	0 Participants	0 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events Any TEAE Leading to Study Withdrawal	16 Participants	7 Participants	13 Participants
Number of Participants With Treatment Emergent Adverse Events Any Death	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events Any Related TEAE	13 Participants	8 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events Any Related Serious TEAE	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events Any TEAE Leading to Stopping of Study Drug	16 Participants	7 Participants	13 Participants
Number of Participants With Treatment Emergent Adverse Events Any Death related to Study Drug	0 Participants	0 Participants	0 Participants

Adverse Events

Interferon Beta-1a

Serious events: 11 serious events

Other events: 273 other events

Deaths: 0 deaths

Ozanimod 0.5 mg

Serious events: 16 serious events

Other events: 88 other events

Deaths: 0 deaths

Ozanimod 1 mg

Serious events: 13 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Interferon Beta-1a n=445 participants at risk Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.	Ozanimod 0.5 mg n=453 participants at risk Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.	Ozanimod 1 mg n=448 participants at risk Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
General disorders Influenza Like Illness	51.0% 227/445 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	4.0% 18/453 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	3.8% 17/448 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.
General disorders Pyrexia	6.3% 28/445 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	1.1% 5/453 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	1.1% 5/448 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.
Infections and infestations Nasopharyngitis	8.1% 36/445 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	9.7% 44/453 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	6.7% 30/448 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.
Infections and infestations Upper Respiratory Tract Infection	5.4% 24/445 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	6.8% 31/453 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	4.0% 18/448 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.
Nervous system disorders Headache	5.6% 25/445 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	6.0% 27/453 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.	7.6% 34/448 • 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. The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one (1) year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene sixty (60) days prior to submission. Celgene may remove confidential and/or proprietary information before publication
Publication restrictions are in place

Restriction type: OTHER