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Clinical Trials in the USA / NCT07732907
Recruiting Observational

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

NCT07732907 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2026-06-04
Last updated
2026-07-29

Condition(s) studied

Multiple SclerosisProgressive Multifocal Leukoencephalopathy

Investigational drug(s) / intervention(s)

Ozanimod →

Ozanimod: As per product label

Study summary

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 .

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: • There are no additional exclusion criteria.

Primary outcome measure(s)

  • Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis — Up 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.

Trial sites (1)

FacilityCityRegionStatus
Bristol Myers Squibb Lawrenceville New Jersey Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732907 on ClinicalTrials.gov ↗ ← All trials in the USA