A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
What it measured
Main measures
Annualized relapse rate (ARR) over 36 months
Up to 3 years
Relapses
Other measures (20)
Annualized relapse rate (ARR) over 12 months and 24 months
Up to 2 years
RelapsesThe cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36
Up to 3 years
MRI lesionsThe cumulative number of GdE brain MRI lesions at Months 12, 24, and 36
Up to 3 years
MRI lesionsProportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36
Up to 3 years
MRI lesionsProportion of participants who are GdE lesion-free at Months 12, 24, and 36
Up to 3 years
MRI lesionsProportion of participants with adverse events (AEs)
Up to 40 months
SafetyProportion of participants with serious adverse events (SAEs)
Up to 40 months
SafetyProportion of participants with AEs leading to discontinuation of study treatment
Up to 3 years
Proportion of participants with laboratory abnormalities
Up to 40 months
SafetyProportion of participants with vital sign abnormalities
Up to 40 months
Safety
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria * Participants must have Multiple Sclerosis (MS) as diagnosed by the 2017 revision of the McDonald criteria. * Participants must be exhibiting a relapsing clinical course consistent with Relapsing Multiple Sclerosis (RMS) and history of brain MRI lesions consistent with MS. * Participants must have an EDSS score between 0 and 5.0 (both inclusive) at baseline. Exclusion Criteria * Participants must not have primary progressive MS at screening. * Participants must not be diagnosed with, or suspected to have neuromyelitis optica spectrum disorder (NMOSD) by clinical symptoms, MRI appearance, and/or supportive serologies according to international consensus criteria.28 A positive test for aquaporin-4 (AQP4) by history or at screening is exclusionary. * Participants must not have clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator. * Specific cardiac conditions are excluded, including history or presence of:. i) Recent (within the past 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, New York Heart Association (NYHA) Class III/IV heart failure, or severe untreated sleep apnea. ii) Second-degree (Mobitz type II) atrioventricular (AV) block, third-degree AV block, sick sinus syndrome, or sino-atrial block unless participants have a pacemaker in place. iii) Prolonged corrected QT interval by Fredericia's formula (QTcF; > 450 msec males and > 470 msec females), or participants at additional risk for QT prolongation. * Participants must not have diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 with hemoglobin A1c > 9%, or diabetic participants with significant comorbid conditions such as retinopathy or nephropathy. * Participants must not receive a live vaccine or a live-attenuated vaccine within 4 weeks prior to first dose or planning to receive a live vaccine or a live-attenuated vaccine during the study or within 28 days after discontinuation from study intervention. * Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity). * Other protocol-defined Inclusion/Exclusion criteria apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.
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History
Started
May 2024
Main results due
Dec 2028
Finished
Mar 2029
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