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NCT Number: NCT06396039

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0002, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986374

Drug

Specified dose on specified days.

Other names: Ozanimod

Primary outcomes

  1. Annualized relapse rate (ARR) over 36 months

    Time frame: Up to 3 years

Secondary outcomes

  1. Annualized relapse rate (ARR) over 12 months and 24 months

    Time frame: Up to 2 years

  2. The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36

    Time frame: Up to 3 years

  3. The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36

    Time frame: Up to 3 years

  4. Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36

    Time frame: Up to 3 years

  5. Proportion of participants who are GdE lesion-free at Months 12, 24, and 36

    Time frame: Up to 3 years

  6. Proportion of participants with adverse events (AEs)

    Time frame: Up to 40 months

  7. Proportion of participants with serious adverse events (SAEs)

    Time frame: Up to 40 months

  8. Proportion of participants with AEs leading to discontinuation of study treatment

    Time frame: Up to 3 years

  9. Proportion of participants with laboratory abnormalities

    Time frame: Up to 40 months

  10. Proportion of participants with vital sign abnormalities

    Time frame: Up to 40 months

  11. Proportion of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 40 months

  12. Proportion of participants with physical examination abnormalities

    Time frame: Up to 40 months

  13. Proportion of participants with serious or opportunistic infections

    Time frame: Up to 40 months

  14. Proportion of participants with malignancy

    Time frame: Up to 40 months

  15. Proportion of participants with bradycardia and heart condition abnormalities

    Time frame: Up to 40 months

  16. Proportion of participants with pulmonary toxicity

    Time frame: Up to 40 months

  17. Proportion of participants with macular edema

    Time frame: Up to 40 months

  18. Proportion of participants with hepatotoxicity

    Time frame: Up to 40 months

  19. Proportion of participants with posterior reversible encephalopathy syndrome

    Time frame: Up to 40 months

  20. Proportion of participants with progressive multifocal leukoencephalopathy

    Time frame: Up to 40 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 2, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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