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

A Phase 4, Multicenter, Single-arm, Open-label Study to Evaluate the Effectiveness and Safety of Oral Ozanimod for Relapsing Multiple Sclerosis (RMS) in Chinese Participants

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

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: BMS-986374

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Local Institution - 0009
  • Fuzhou, China, 350001
    • Local Institution - 0025
  • Guiyang, China, 550000
    • Local Institution - 0010
  • Hohhot, China, 10017
    • Local Institution - 0013
  • Shanghai, China, 200127
    • Local Institution - 0014
  • Shenyang, China, 110004
    • Local Institution - 0021
  • Tianjin, China, 300052
    • Local Institution - 0001
  • Xianyang, China, 712000
    • Local Institution - 0020
  • Beijing
    • Beijing, Beijing, China, 100070
      • Local Institution - 0002
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0012
    • Guangzhou, Guangdong, China, 510260
      • Local Institution - 0022
    • Shenzhen, Guangdong, China, 518036
      • Local Institution - 0008
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Local Institution - 0004
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Local Institution - 0006
  • Henan
    • Zhengzhou, Henan, China, 450004
      • Local Institution - 0018
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0007
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0003
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution - 0005
  • Shan1xi
    • Taiyuan, Shan1xi, China, 030001
      • Local Institution - 0015
    • Urumqi, Shan1xi, China, 830054
      • Local Institution - 0023
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Local Institution - 0016
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0011
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Local Institution - 0024
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution - 0019
    • Wenzhou, Zhejiang, China, 32500
      • Local Institution - 0017

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of BMS-986374	Drug: BMS-986374; Specified dose on specified days.; Other Names: Ozanimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized relapse rate (ARR) over 36 months	Up to 3 years

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Ozanimod
• Other Study ID Numbers: IM047-1096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes