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Clinical Trials in China / NCT06396039
Active, not recruiting Phase 4

A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

NCT06396039 · tracked via the Priya Life Science China tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 4
Started
2024-05-15
Last updated
2025-04-16

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

BMS-986374

BMS-986374: Specified dose on specified days.

Study summary

The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Local Institution - 0002 Beijing Beijing Municipality
Local Institution - 0012 Guangzhou Guangdong
Local Institution - 0022 Guangzhou Guangdong
Local Institution - 0008 Shenzhen Guangdong
Local Institution - 0004 Shijiazhuang Hebei
Local Institution - 0006 Harbin Heilongjiang
Local Institution - 0018 Zhengzhou Henan
Local Institution - 0007 Wuhan Hubei
Local Institution - 0003 Nanchang Jiangxi
Local Institution - 0005 Changchun Jilin
Local Institution - 0015 Taiyuan Shan1xi
Local Institution - 0023 Ürümqi Shan1xi
Local Institution - 0016 Shanghai Shanghai Municipality
Local Institution - 0011 Chengdu Sichuan
Local Institution - 0024 Kunming Yunnan
Local Institution - 0019 Hangzhou Zhejiang
Local Institution - 0017 Wenzhou Zhejiang
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

More Bristol-Myers Squibb trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06396039 on ClinicalTrials.gov ↗ ← All trials in China