Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia

Part of paid clinical trials in Lawrenceville, New Jersey.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07732907
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ozanimod — DRUG
    As per product label

Study Details

This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .

Key Dates

First listed
Jul 29, 2026
Start date
Jun 4, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2041
Completion
Jul 31, 2041

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Ozanimod Cohort
    Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy

Primary Outcome Measure

Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis [ Time Frame: Up to 15 years ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
  • First line of the email MUST contain NCT # and Site #.

Locations (1)

FacilityCityStateZIPSite coordinators
Bristol Myers SquibbLawrencevilleNew Jersey08648-

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