Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
Recruiting now
Conditions studied: Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
In brief
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 facts
- Study ID
- NCT07732907
- Run by
- Bristol-Myers Squibb
- People needed
- 15
- Starts
- 2026-06-04
- Expected to finish
- 2041-07-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- There are no additional exclusion criteria.
Where it is running
- Bristol Myers Squibb — Lawrenceville, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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