A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
NCT ID: NCT06396039
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
84 participants
INTERVENTIONAL
2024-05-15
2029-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of BMS-986374
BMS-986374
Specified dose on specified days.
Interventions
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BMS-986374
Specified dose on specified days.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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).
18 Years
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0002
Beijing, Beijing Municipality, China
Local Institution - 0012
Guangzhou, Guangdong, China
Local Institution - 0022
Guangzhou, Guangdong, China
Local Institution - 0008
Shenzhen, Guangdong, China
Local Institution - 0004
Shijiazhuang, Hebei, China
Local Institution - 0006
Harbin, Heilongjiang, China
Local Institution - 0018
Zhengzhou, Henan, China
Local Institution - 0007
Wuhan, Hubei, China
Local Institution - 0003
Nanchang, Jiangxi, China
Local Institution - 0005
Changchun, Jilin, China
Local Institution - 0015
Taiyuan, Shan1xi, China
Local Institution - 0023
Ürümqi, Shan1xi, China
Local Institution - 0016
Shanghai, Shanghai Municipality, China
Local Institution - 0011
Chengdu, Sichuan, China
Local Institution - 0024
Kunming, Yunnan, China
Local Institution - 0019
Hangzhou, Zhejiang, China
Local Institution - 0017
Wenzhou, Zhejiang, China
Local Institution - 0009
Beijing, , China
Local Institution - 0025
Fuzhou, , China
Local Institution - 0010
Guiyang, , China
Local Institution - 0013
Hohhot, , China
Local Institution - 0014
Shanghai, , China
Local Institution - 0021
Shenyang, , China
Local Institution - 0001
Tianjin, , China
Local Institution - 0020
Xianyang, , China
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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IM047-1096
Identifier Type: -
Identifier Source: org_study_id
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