Checks rare brain infection risk in multiple sclerosis patients taking ozanimod
Looks at a rare brain infection, PML, in people with multiple sclerosis taking ozanimod.
Plain-language title generated from the registry record
Registry title: Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
Key facts
- Where
- Lawrenceville, United StatesSee the site
Where in United States
- Bristol Myers SquibbLawrenceville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07732907
- Record updated
- 29 July 2026
- Original description
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 .Read full original descriptionShow less
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
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 .
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.
Exclusion: There are no additional exclusion criteria.