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Observational Study of PML Risk with Zeposia in Multiple Sclerosis

This study is looking at the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people with multiple sclerosis (MS) who are taking the medication Zeposia (ozanimod). Researchers will review reported cases of PML to understand how often it occurs and what factors might be linked to it, such as age, how long someone has taken Zeposia, and other medical history. The study aims to describe the characteristics of patients who develop PML while on Zeposia. You could be eligible if you have MS and have had a specific adverse event report related to PML or the John Cunningham virus (JCV) between June 2026 and July 2041.

Study design
This is an observational study that plans to include 15 participants. It will collect and review information from reported cases.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the proportion of PML cases for up to 15 years.

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NCT07732907

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

Recruiting
Not specifiedAll AgesObservational
Bristol-Myers Squibb
~15 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Ozanimod

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis
Measured over Up to 15 years

Conditions

Multiple Sclerosis
Progressive Multifocal Leukoencephalopathy

Explore related trials

Multiple SclerosisProgressive Multifocal LeukoencephalopathyJohn Cunningham virus

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adverse event (AE) report with MedDRA Preferred Term of " John Cunningham virus (JCV) cerebrospinal fluid test positive", " JCV granule cell neuronopathy", or "Progressive multifocal leukoencephalopathy (PML)" reported to the Sponsor between 4-Jun-2026 and 31-Jul-2041.
AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.
Diagnosis of multiple sclerosis before the initial AE report.
Exposure to at least one dose of ozanimod before onset of PML symptoms.
PML event assessed as "definite" or "probable" by the adjudication committee.
PML assessed as "related" to ozanimod by the adjudication committee.

What this trial measures

  • Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosisUp to 15 years

    Participant characteristics and potential risk factors evaluated include: age at PML symptom onset, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, lymphopenia at PML diagnosis, duration of lymphopenia, anti-John Cunningham virus (JCV) antibody status within 6 months after ozanimod initiation, anti-JCV antibody status at PML symptom onset, and change in JCV index before PML symptom onset.