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

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting

Phase 4

Conditions

Relapsing Multiple Sclerosis

Treatments

Drug: BMS-986374

Study type

Interventional

Funder types

Industry

Identifiers

NCT06396039

IM047-1096

Details and patient eligibility

About

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

Enrollment

84 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.