A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
- Registration Number
- NCT06396039
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of BMS-986374 BMS-986374 -
- Primary Outcome Measures
Name Time Method Annualized relapse rate (ARR) over 36 months Up to 3 years
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (25)
Local Institution - 0008
🇨🇳Shenzhen, Guangdong, China
Local Institution - 0002
🇨🇳Beijing, Beijing, China
Local Institution - 0012
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0022
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0004
🇨🇳Shijiazhuang, Hebei, 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
🇨🇳Urumqi, Shan1xi, China
Local Institution - 0011
🇨🇳Chengdu, Sichuan, China
Local Institution - 0024
🇨🇳Kunming, Yunnan, China
Local Institution - 0017
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 0009
🇨🇳Beijing, China
Local Institution - 0010
🇨🇳Guiyang, China
Local Institution - 0013
🇨🇳Hohhot, China
Local Institution - 0001
🇨🇳Tianjin, China
Local Institution - 0020
🇨🇳Xianyang, China
Local Institution - 0006
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0016
🇨🇳Shanghai, Shanghai, China
Local Institution - 0019
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0025
🇨🇳Fuzhou, China
Local Institution - 0014
🇨🇳Shanghai, China
Local Institution - 0021
🇨🇳Shenyang, China