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

NCT06396039 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: IM047-1096
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate (ARR) over 36 months

  Up to 3 years

Secondary Outcomes (20)

• 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

Study Arms (1)

Administration of BMS-986374

EXPERIMENTAL

Drug: BMS-986374

Interventions

BMS-986374 DRUG

Specified dose on specified days.

Also known as: Ozanimod

Administration of BMS-986374

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants must not have primary progressive MS at screening.
• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (25)

Local Institution - 0002

Beijing, Beijing Municipality, 100070, China

Location

Local Institution - 0012

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0022

Guangzhou, Guangdong, 510260, China

Location

Local Institution - 0008

Shenzhen, Guangdong, 518036, China

Location

Local Institution - 0004

Shijiazhuang, Hebei, 050000, China

Location

Local Institution - 0006

Harbin, Heilongjiang, 150086, China

Location

Local Institution - 0018

Zhengzhou, Henan, 450004, China

Location

Local Institution - 0007

Wuhan, Hubei, 430030, China

Location

Local Institution - 0003

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0005

Changchun, Jilin, 130021, China

Location

Local Institution - 0015

Taiyuan, Shan1xi, 030001, China

Location

Local Institution - 0023

Ürümqi, Shan1xi, 830054, China

Location

Local Institution - 0016

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 0011

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0024

Kunming, Yunnan, 650032, China

Location

Local Institution - 0019

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0017

Wenzhou, Zhejiang, 32500, China

Location

Local Institution - 0009

Beijing, 100034, China

Location

Local Institution - 0025

Fuzhou, 350001, China

Location

Local Institution - 0010

Guiyang, 550000, China

Location

Local Institution - 0013

Hohhot, 10017, China

Location

Local Institution - 0014

Shanghai, 200127, China

Location

Local Institution - 0021

Shenyang, 110004, China

Location

Local Institution - 0001

Tianjin, 300052, China

Location

Local Institution - 0020

Xianyang, 712000, China

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Interventions

ozanimod

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)