Relapsing Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.
Interventions
DRUGBMS-986374
Specified dose on specified days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized relapse rate (ARR) over 36 months | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36 | Up to 3 years |
| The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36 | Up to 3 years |
| Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36 | Up to 3 years |
| Proportion of participants who are GdE lesion-free at Months 12, 24, and 36 | Up to 3 years |
| Proportion of participants with adverse events (AEs) | Up to 40 months |
| Proportion of participants with serious adverse events (SAEs) | Up to 40 months |
| Proportion of participants with AEs leading to discontinuation of study treatment | Up to 3 years |
| Proportion of participants with laboratory abnormalities | Up to 40 months |
| Proportion of participants with vital sign abnormalities | Up to 40 months |
| Annualized relapse rate (ARR) over 12 months and 24 months | Up to 2 years |
| Proportion of participants with physical examination abnormalities | Up to 40 months |
| Proportion of participants with serious or opportunistic infections | Up to 40 months |
| Proportion of participants with malignancy | Up to 40 months |
| Proportion of participants with bradycardia and heart condition abnormalities | Up to 40 months |
| Proportion of participants with pulmonary toxicity | Up to 40 months |
| Proportion of participants with macular edema | Up to 40 months |
| Proportion of participants with hepatotoxicity | Up to 40 months |
| Proportion of participants with posterior reversible encephalopathy syndrome | Up to 40 months |
| Proportion of participants with progressive multifocal leukoencephalopathy | Up to 40 months |
| Proportion of participants with electrocardiogram (ECG) abnormalities | Up to 40 months |
Countries
China
Outcome results
None listed