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

NCT07732907 — Recruiting, 15 participants, Bristol-Myers Squibb

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Registry	NCT07732907
Status	Recruiting
Study type	Observational
Enrollment	15 (Estimated)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
Interventions	Ozanimod (Drug)
Dates	start 2026-06-04, primary completion 2041-07-31 (estimated), completion 2041-07-31 (estimated), first posted 2026-07-29, last updated 2026-07-29
Locations	1 site in United States

-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 .

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+Arms and interventions

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

Ozanimod (Drug): As per product label

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category [Up to 15 years]: Incidence rates will be calculated as the number of PML cases divided by estimated person-years of ozanimod exposure and reported as cases per 100,000 person-years with 95% confidence intervals. Incidence rates will be reported overall and by risk factor category, including age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, and anti-John Cunningham virus antibody status within 6 months after ozanimod initiation.

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Bristol Myers Squibb	Lawrenceville, New Jersey	United States	Recruiting

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb