Adults 18 to 55, any sex, with Relapsing Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24Primary· From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
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.
Group
Value
95% CI
Placebo
11.1
± 29.87
Ozanimod 0.5 mg
1.9
± 4.77
Ozanimod 1 mg
1.5
± 3.44
The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24Secondary· Week 24
MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Group
Value
95% CI
Placebo
3.2
± 9.81
Ozanimod 0.5 mg
0.4
± 1.27
Ozanimod 1 mg
0.2
± 0.59
The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24Secondary· Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
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.
Group
Value
95% CI
Placebo
9.0
± 20.87
Ozanimod 0.5 mg
1.4
± 3.21
Ozanimod 1 mg
0.8
± 1.86
Adjusted Annualized Relapse Rate (ARR) at Week 24Secondary· Week 24
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 syst
Group
Value
95% CI
Placebo
0.50
0.22 – 1.15
Ozanimod 0.5 mg
0.35
0.15 – 0.82
Ozanimod 1 mg
0.24
0.09 – 0.61
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment PeriodSecondary· 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.
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
Any TEAE
Group
Value
95% CI
Placebo
52
Ozanimod 0.5 mg
57
Ozanimod 1 mg
47
Any moderate or severe TEAE
Group
Value
95% CI
Placebo
23
Ozanimod 0.5 mg
23
Ozanimod 1 mg
13
Any severe TEAE
Group
Value
95% CI
Placebo
1
Ozanimod 0.5 mg
2
Ozanimod 1 mg
1
Any TEAE related to study drug
Group
Value
95% CI
Placebo
1
Ozanimod 0.5 mg
1
Ozanimod 1 mg
0
Any serious TEAE
Group
Value
95% CI
Placebo
0
Ozanimod 0.5 mg
3
Ozanimod 1 mg
0
Any serious TEAE related to study drug
Group
Value
95% CI
Placebo
0
Ozanimod 0.5 mg
0
Ozanimod 1 mg
0
Any TEAE leading to discontinuation of study drug
Group
Value
95% CI
Placebo
0
Ozanimod 0.5 mg
0
Ozanimod 1 mg
0
Any death related to study drug
Group
Value
95% CI
Placebo
0
Ozanimod 0.5 mg
0
Ozanimod 1 mg
0
Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod ExposureSecondary· 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.
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 assess
Any TEAE
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
26
Ozanimod 0.5 mg
73
Placebo / Ozanimod 1 mg
32
Ozanimod 1 mg
61
Any moderate or severe TEAE
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
17
Ozanimod 0.5 mg
42
Placebo / Ozanimod 1 mg
18
Ozanimod 1 mg
35
Any severe TEAE
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
2
Ozanimod 0.5 mg
4
Placebo / Ozanimod 1 mg
1
Ozanimod 1 mg
2
Any TEAE related to study drug
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
2
Ozanimod 0.5 mg
3
Placebo / Ozanimod 1 mg
1
Ozanimod 1 mg
3
Any serious TEAE
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
2
Ozanimod 0.5 mg
10
Placebo / Ozanimod 1 mg
3
Ozanimod 1 mg
6
Any serious TEAE related to study drug
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
0
Ozanimod 0.5 mg
0
Placebo / Ozanimod 1 mg
0
Ozanimod 1 mg
0
Any TEAE leading to discontinuation of study drug
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
2
Ozanimod 0.5 mg
1
Placebo / Ozanimod 1 mg
1
Ozanimod 1 mg
0
Any death related to study drug
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
0
Ozanimod 0.5 mg
0
Placebo / Ozanimod 1 mg
0
Ozanimod 1 mg
0
Number of Gadolinium-Enhancing (GdE) Lesions During the Extension PeriodSecondary· Weeks 24, 48, 72, and 120
MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Week 24 (start of extension period)
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
4.5
± 13.02
Ozanimod 0.5 mg
0.4
± 1.28
Placebo / Ozanimod 1 mg
1.9
± 5.93
Ozanimod 1 mg
0.2
± 0.60
Week 48
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
0.6
± 2.63
Ozanimod 0.5 mg
0.4
± 1.30
Placebo / Ozanimod 1 mg
0.4
± 1.35
Ozanimod 1 mg
0.2
± 0.56
Week 72
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
0.4
± 1.95
Ozanimod 0.5 mg
0.4
± 1.41
Placebo / Ozanimod 1 mg
0.1
± 0.28
Ozanimod 1 mg
0.2
± 0.56
Week 120
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
0.1
± 0.46
Ozanimod 0.5 mg
0.4
± 1.49
Placebo / Ozanimod 1 mg
0.1
± 0.37
Ozanimod 1 mg
0.2
± 0.51
Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions In the Extension PeriodSecondary· 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.
Week 12 to 24
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
10.8
± 3.58
Ozanimod 0.5 mg
1.4
± 0.35
Placebo / Ozanimod 1 mg
7.3
± 3.07
Ozanimod 1 mg
0.9
± 0.21
Week 24 to 72
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
4.3
± 1.99
Ozanimod 0.5 mg
2.8
± 0.72
Placebo / Ozanimod 1 mg
1.5
± 0.39
Ozanimod 1 mg
1.9
± 0.84
Week 72 to 120
Group
Value
95% CI
Placebo / Ozanimod 0.5 mg
3.2
± 1.31
Ozanimod 0.5 mg
2.3
± 0.61
Placebo / Ozanimod 1 mg
1.9
± 0.48
Ozanimod 1 mg
0.7
± 0.16
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).
The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07271069 — Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
· recruiting
NCT06862960 — Ozanimod in Patients With Alzheimer's Disease
· Phase 2
· not yet recruiting
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap
· Phase 3
· recruiting
NCT06126835 — A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
· active not recruiting
NCT06529406 — Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 11 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01628393.