Trial Outcomes & Findings for Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients (NCT NCT01628393)

Last Updated: 2021-02-11

Results Overview

The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

258 participants

Primary outcome timeframe

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

Results posted on

2021-02-11

Participant Flow

The study was conducted at 55 study centers in 13 countries including the United States, Europe and Russia. Participants with multiple sclerosis (MS) were recruited between September 2012 and October 2013. The study consisted of a 24-week placebo-controlled treatment period and an optional 96-week blinded extension period.

Participants were randomly assigned in a 1:1:1 ratio to receive one of two daily doses of ozanimod (0.5 mg or 1 mg) or matching placebo for 24 weeks. Those who completed 24 weeks could enter a blinded extension phase and continue on their assigned doses of ozanimod, whereas those assigned to placebo were re-randomized in a 1:1 ratio to ozanimod 0.5 mg or 1 mg. In both periods the randomization was stratified by country.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.	Ozanimod 0.5 mg Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks of treatment.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks of treatment.	Placebo / Ozanimod 0.5 mg Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg PO daily during the blinded extension period for 96 weeks.	Placebo / Ozanimod 1 mg Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg PO daily during the blinded extension period for 96 weeks.
Placebo-controlled Treatment Period STARTED	88	87	83	0	0
Placebo-controlled Treatment Period COMPLETED	85	85	82	0	0
Placebo-controlled Treatment Period NOT COMPLETED	3	2	1	0	0
Blinded Active Extension Period STARTED	0	85	81	41	42
Blinded Active Extension Period COMPLETED	0	75	75	37	36
Blinded Active Extension Period NOT COMPLETED	0	10	6	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.	Ozanimod 0.5 mg Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks of treatment.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks of treatment.	Placebo / Ozanimod 0.5 mg Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg PO daily during the blinded extension period for 96 weeks.	Placebo / Ozanimod 1 mg Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg PO daily during the blinded extension period for 96 weeks.
Placebo-controlled Treatment Period Lost to Follow-up	1	0	0	0	0
Placebo-controlled Treatment Period Protocol Violation	0	1	0	0	0
Placebo-controlled Treatment Period Withdrawal by Subject	2	1	1	0	0
Blinded Active Extension Period Adverse Event	0	1	0	2	2
Blinded Active Extension Period Lack of Efficacy	0	0	2	0	2
Blinded Active Extension Period Physician Decision	0	3	0	1	0
Blinded Active Extension Period Protocol Violation	0	0	2	1	0
Blinded Active Extension Period Withdrawal by Subject	0	6	2	0	2

Baseline Characteristics

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=88 Participants Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.	Ozanimod 1 mg n=83 Participants Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.	Total n=258 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 8.67 • n=5 Participants	38.1 years STANDARD_DEVIATION 9.17 • n=7 Participants	38.4 years STANDARD_DEVIATION 9.82 • n=5 Participants	38.5 years STANDARD_DEVIATION 9.19 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	60 Participants n=7 Participants	59 Participants n=5 Participants	181 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	27 Participants n=7 Participants	24 Participants n=5 Participants	77 Participants n=4 Participants
Race/Ethnicity, Customized White	87 Participants n=5 Participants	84 Participants n=7 Participants	83 Participants n=5 Participants	254 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment North America	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Western Europe	6 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment Eastern Europe	78 Participants n=5 Participants	79 Participants n=7 Participants	76 Participants n=5 Participants	233 Participants n=4 Participants
Country of Enrollment Poland	44 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	132 Participants n=4 Participants
Country of Enrollment Serbia	12 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Country of Enrollment Ukraine	9 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Country of Enrollment Russia	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Country of Enrollment United States	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Country of Enrollment Romania	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Country of Enrollment Georgia	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Country of Enrollment Bulgaria	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Country of Enrollment Greece	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Country of Enrollment Spain	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Country of Enrollment Italy	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Country of Enrollment Belgium	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Country of Enrollment Hungary	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age at Multiple Sclerosis Diagnosis	33.9 years STANDARD_DEVIATION 8.30 • n=5 Participants	34.8 years STANDARD_DEVIATION 10.01 • n=7 Participants	34.4 years STANDARD_DEVIATION 9.51 • n=5 Participants	34.4 years STANDARD_DEVIATION 9.27 • n=4 Participants
Time Since Multiple Sclerosis Diagnosis	4.6 years STANDARD_DEVIATION 5.12 • n=5 Participants	2.8 years STANDARD_DEVIATION 4.98 • n=7 Participants	3.6 years STANDARD_DEVIATION 4.43 • n=5 Participants	3.7 years STANDARD_DEVIATION 4.90 • n=4 Participants
Expanded Disability Status Scale (EDSS) Score at Baseline	2.85 units on a scale STANDARD_DEVIATION 1.273 • n=5 Participants	2.94 units on a scale STANDARD_DEVIATION 1.287 • n=7 Participants	2.86 units on a scale STANDARD_DEVIATION 1.213 • n=5 Participants	2.88 units on a scale STANDARD_DEVIATION 1.255 • n=4 Participants
Time Since MS Symptom Onset	8.1 years STANDARD_DEVIATION 6.97 • n=5 Participants	6.0 years STANDARD_DEVIATION 6.41 • n=7 Participants	6.2 years STANDARD_DEVIATION 5.79 • n=5 Participants	6.8 years STANDARD_DEVIATION 6.47 • n=4 Participants
Number of Relapses Within the Last 12 months Prior to Screening	1.3 relapses STANDARD_DEVIATION 0.64 • n=5 Participants	1.5 relapses STANDARD_DEVIATION 1.18 • n=7 Participants	1.3 relapses STANDARD_DEVIATION 0.73 • n=5 Participants	1.4 relapses STANDARD_DEVIATION 0.88 • n=4 Participants
Number of Relapses Within the Last 24 months Prior to Screening	1.8 relapses STANDARD_DEVIATION 1.01 • n=5 Participants	2.0 relapses STANDARD_DEVIATION 1.79 • n=7 Participants	1.9 relapses STANDARD_DEVIATION 1.05 • n=5 Participants	1.9 relapses STANDARD_DEVIATION 1.33 • n=4 Participants
Number of Gadolinium Enhancing (GdE) Lesions	1.4 lesions STANDARD_DEVIATION 3.36 • n=5 Participants	0.9 lesions STANDARD_DEVIATION 1.42 • n=7 Participants	1.3 lesions STANDARD_DEVIATION 2.75 • n=5 Participants	1.2 lesions STANDARD_DEVIATION 2.64 • n=4 Participants

PRIMARY outcome

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

Population: The ITT population is defined as all randomized participants who received at least 1 dose of study drug. Missing data were imputed using the last valid non-missing, post-baseline observation which was carried forward if the participant was only missing 1 or 2 consecutive post-baseline scans. If there were no post-baseline data or the participant was missing \> 2 consecutive scans, the mean number of lesions from participants in the same treatment group and visit was used as the imputed value.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=88 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=83 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24	11.1 lesions Standard Deviation 29.87	1.9 lesions Standard Deviation 4.77	1.5 lesions Standard Deviation 3.44	—

SECONDARY outcome

Timeframe: Week 24

Population: The ITT population is defined as all randomized participants who received at least 1 dose of study drug. Missing GdE data values were imputed using the mean number of lesions from participants in the same treatment group at the same visit.

MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=88 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=83 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24	3.2 lesions Standard Deviation 9.81	0.4 lesions Standard Deviation 1.27	0.2 lesions Standard Deviation 0.59	—

SECONDARY outcome

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

Population: The ITT population is defined as all randomized participants who received at least 1 dose of study drug. Missing new or enlarging T2 data values were imputed using the mean from participants of the same treatment group at the same visit.

The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=88 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=83 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24	9.0 lesions Standard Deviation 20.87	1.4 lesions Standard Deviation 3.21	0.8 lesions Standard Deviation 1.86	—

SECONDARY outcome

Timeframe: Week 24

Population: The ITT population is defined as all randomized participants who received at least 1 dose of study drug.

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 confirmed relapses divided by the total number of days in the study \* 365. ARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=88 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=83 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Adjusted Annualized Relapse Rate (ARR) at Week 24	0.50 relapses/year Interval 0.22 to 1.15	0.35 relapses/year Interval 0.15 to 0.82	0.24 relapses/year Interval 0.09 to 0.61	—

SECONDARY outcome

Timeframe: 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.

Population: Safety population was defined as all participants who received at least one dose of study drug.

An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes. The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=88 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=87 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=83 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any TEAE	52 Participants	57 Participants	47 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any moderate or severe TEAE	23 Participants	23 Participants	13 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any severe TEAE	1 Participants	2 Participants	1 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any TEAE related to study drug	1 Participants	1 Participants	0 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any serious TEAE	0 Participants	3 Participants	0 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any serious TEAE related to study drug	0 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any TEAE leading to discontinuation of study drug	0 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period Any death related to study drug	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 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 each treatment group respectively.

Population: Safety population was defined as all participants who received at least one dose of study drug in the blinded extension phase

AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes. The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=41 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=85 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=42 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg n=81 Participants Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any TEAE	26 Participants	73 Participants	32 Participants	61 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any moderate or severe TEAE	17 Participants	42 Participants	18 Participants	35 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any severe TEAE	2 Participants	4 Participants	1 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any TEAE related to study drug	2 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any serious TEAE	2 Participants	10 Participants	3 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any serious TEAE related to study drug	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any TEAE leading to discontinuation of study drug	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure Any death related to study drug	0 Participants	0 Participants	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Weeks 24, 48, 72, and 120

Population: Participants who entered the blinded extension period, received at least 1 dose of study drug, and had any post-baseline assessment in the blinded extension period. Includes participants with non-missing MRI results at each time point.

MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=41 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=85 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=42 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg n=81 Participants Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Number of Gadolinium-Enhancing (GdE) Lesions During the Extension Period Week 120	0.1 lesions Standard Deviation 0.46	0.4 lesions Standard Deviation 1.49	0.1 lesions Standard Deviation 0.37	0.2 lesions Standard Deviation 0.51
Number of Gadolinium-Enhancing (GdE) Lesions During the Extension Period Week 24 (start of extension period)	4.5 lesions Standard Deviation 13.02	0.4 lesions Standard Deviation 1.28	1.9 lesions Standard Deviation 5.93	0.2 lesions Standard Deviation 0.60
Number of Gadolinium-Enhancing (GdE) Lesions During the Extension Period Week 48	0.6 lesions Standard Deviation 2.63	0.4 lesions Standard Deviation 1.30	0.4 lesions Standard Deviation 1.35	0.2 lesions Standard Deviation 0.56
Number of Gadolinium-Enhancing (GdE) Lesions During the Extension Period Week 72	0.4 lesions Standard Deviation 1.95	0.4 lesions Standard Deviation 1.41	0.1 lesions Standard Deviation 0.28	0.2 lesions Standard Deviation 0.56

POST_HOC outcome

Timeframe: Weeks 12 to 24 of the placebo-controlled period and Week 24 to 72 (first year) and Week 72 - 120 (second year) in the extension period

The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24 in the placebo controlled period (reference) and during the first and second years of the extension period. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Outcome measures

Outcome measures
Measure	Placebo / Ozanimod 0.5 mg n=41 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 0.5 mg n=85 Participants Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.	Placebo / Ozanimod 1 mg n=42 Participants Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.	Ozanimod 1 mg n=81 Participants Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.
Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions In the Extension Period Week 12 to 24	10.8 lesions Standard Error 3.58	1.4 lesions Standard Error 0.35	7.3 lesions Standard Error 3.07	0.9 lesions Standard Error 0.21
Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions In the Extension Period Week 24 to 72	4.3 lesions Standard Error 1.99	2.8 lesions Standard Error 0.72	1.5 lesions Standard Error 0.39	1.9 lesions Standard Error 0.84
Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions In the Extension Period Week 72 to 120	3.2 lesions Standard Error 1.31	2.3 lesions Standard Error 0.61	1.9 lesions Standard Error 0.48	0.7 lesions Standard Error 0.16

Adverse Events

Placebo-Controlled Period: Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo-Controlled Period: Ozanimod 0.5 mg

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo-Controlled Period: Ozanimod 1.0 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Extension Period: Ozanimod 0.5 mg

Serious events: 10 serious events

Other events: 52 other events

Deaths: 0 deaths

Extension Period: Ozanimod 1.0 mg

Serious events: 9 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-Controlled Period: Placebo n=88 participants at risk Participants received placebo capsules PO daily during the 24-week placebo-controlled period.	Placebo-Controlled Period: Ozanimod 0.5 mg n=87 participants at risk Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled period.	Placebo-Controlled Period: Ozanimod 1.0 mg n=83 participants at risk Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled period.	Extension Period: Ozanimod 0.5 mg n=126 participants at risk Participants received ozanimod 0.5 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).	Extension Period: Ozanimod 1.0 mg n=123 participants at risk Participants received ozanimod 1 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Gastrointestinal disorders Irritable Bowel Syndrome	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Hepatobiliary disorders Hepatitis	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Infections and infestations Proctitis Infectious	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Injury, poisoning and procedural complications Concussion	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Injury, poisoning and procedural complications Injury	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Nervous system disorders Cauda Equina Syndrome	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Nervous system disorders Headache	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Nervous system disorders Intracranial Aneurysm	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Nervous system disorders Optic Neuritis	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	1.1% 1/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Psychiatric disorders Depression	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Psychiatric disorders Somatoform Disorder	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	1.1% 1/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Renal and urinary disorders Urethral Stenosis	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Reproductive system and breast disorders Uterine Cervical Squamous Metaplasia	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	1.1% 1/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Reproductive system and breast disorders Uterine Haemorrhage	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Skin and subcutaneous tissue disorders Stasis Dermatitis	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.81% 1/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Vascular disorders Hypertension	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.79% 1/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	0.00% 0/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.

Other adverse events

Other adverse events
Measure	Placebo-Controlled Period: Placebo n=88 participants at risk Participants received placebo capsules PO daily during the 24-week placebo-controlled period.	Placebo-Controlled Period: Ozanimod 0.5 mg n=87 participants at risk Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled period.	Placebo-Controlled Period: Ozanimod 1.0 mg n=83 participants at risk Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled period.	Extension Period: Ozanimod 0.5 mg n=126 participants at risk Participants received ozanimod 0.5 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).	Extension Period: Ozanimod 1.0 mg n=123 participants at risk Participants received ozanimod 1 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).
Infections and infestations Nasopharyngitis	13.6% 12/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	12.6% 11/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	6.0% 5/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	13.5% 17/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	13.8% 17/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Infections and infestations Upper Respiratory Tract Infection	3.4% 3/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	4.6% 4/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	3.6% 3/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	15.9% 20/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	8.9% 11/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Infections and infestations Urinary Tract Infection	2.3% 2/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	6.9% 6/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	2.4% 2/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	5.6% 7/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	3.3% 4/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Investigations Alanine Aminotransferase Increased	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	3.4% 3/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	4.8% 4/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	7.9% 10/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	9.8% 12/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	2.3% 2/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	6.0% 5/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	8.7% 11/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	6.5% 8/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Musculoskeletal and connective tissue disorders Back Pain	10.2% 9/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	5.7% 5/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	2.4% 2/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	4.0% 5/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	5.7% 7/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Nervous system disorders Headache	9.1% 8/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	5.7% 5/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	3.6% 3/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	5.6% 7/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	7.3% 9/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.
Vascular disorders Hypertension	1.1% 1/88 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	1.1% 1/87 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	2.4% 2/83 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	6.3% 8/126 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.	1.6% 2/123 • Placebo-controlled 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. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
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Restriction type: OTHER