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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of BMS-986374 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986374 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate (ARR) over 36 months | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate (ARR) over 12 months and 24 months | Up to 2 years | |
| The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36 | Up to 3 years |
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Inclusion Criteria
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Beijing | Beijing Municipality | 100070 | China | ||
| Local Institution - 0012 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/disclosure-commitment.html
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| 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 |
| Proportion of participants with electrocardiogram (ECG) abnormalities | Up to 40 months |
| 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 |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| Local Institution - 0022 | Guangzhou | Guangdong | 510260 | China |
| Local Institution - 0008 | Shenzhen | Guangdong | 518036 | China |
| Local Institution - 0004 | Shijiazhuang | Hebei | 050000 | China |
| Local Institution - 0006 | Harbin | Heilongjiang | 150086 | China |
| Local Institution - 0018 | Zhengzhou | Henan | 450004 | China |
| Local Institution - 0007 | Wuhan | Hubei | 430030 | China |
| Local Institution - 0003 | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0005 | Changchun | Jilin | 130021 | China |
| Local Institution - 0015 | Taiyuan | Shan1xi | 030001 | China |
| Local Institution - 0023 | Ürümqi | Shan1xi | 830054 | China |
| Local Institution - 0016 | Shanghai | Shanghai Municipality | 200030 | China |
| Local Institution - 0011 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0024 | Kunming | Yunnan | 650032 | China |
| Local Institution - 0019 | Hangzhou | Zhejiang | 310016 | China |
| Local Institution - 0017 | Wenzhou | Zhejiang | 32500 | China |
| Local Institution - 0009 | Beijing | 100034 | China |
| Local Institution - 0025 | Fuzhou | 350001 | China |
| Local Institution - 0010 | Guiyang | 550000 | China |
| Local Institution - 0013 | Hohhot | 10017 | China |
| Local Institution - 0014 | Shanghai | 200127 | China |
| Local Institution - 0021 | Shenyang | 110004 | China |
| Local Institution - 0001 | Tianjin | 300052 | China |
| Local Institution - 0020 | Xianyang | 712000 | China |
| ID | Term |
|---|---|
| C000607776 | ozanimod |
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