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Clinical trial Recruiting at 1 site Observational

PML risk in people with MS treated with ozanimod

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

Run by Bristol-Myers Squibb · NCT07732907 · Data updated 2026-11-12

This study looks at whether people with MS who take ozanimod develop PML and how often it happens.

Quick facts

Study typeObservational
SexAll
Enrollment15 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations1 site (Lawrenceville, New Jersey)
StatusRecruiting
StartedJune 4, 2026
Main results expectedJuly 31, 2041
Study endsJuly 31, 2041
Registry record updatedJuly 29, 2026
Trial IDNCT07732907 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with multiple sclerosis who have had an AE report suggesting PML or JC virus–related findings after ozanimod exposure.

Probably not a fit

Patients without PML or without ozanimod exposure or related signals may not benefit from this study’s findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects reported cases of progressive multifocal leukoencephalopathy (PML) in MS patients treated with ozanimod (Ozanimod). It analyzes patient characteristics, exposure duration, prior immunosuppressant use, lymphopenia, and JC virus status to describe and estimate the PML risk. Data come from spontaneous post-marketing reports, observational studies with primary data collection, or patient support programs. An adjudication committee determines PML-relatedness to ozanimod and classifies cases as definite or probable.

Why it matters

Potential benefit: If successful, the study could clarify the real-world PML risk associated with ozanimod to inform safer prescribing and monitoring.

How similar studies have gone: Prior work has described PML cases in MS, but this study uses a focused, ozanimod-specific post-marketing dataset to estimate risk more directly.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Bristol Myers Squibb
    Lawrenceville, New Jersey, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Multiple Sclerosis 473Progressive Multifocal Leukoencephalopathy 5Bristol-Myers Squibb 102
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.