NCT07732907 Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
| NCT ID | NCT07732907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2041-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2026-06-04 with a primary completion date of 2041-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07732907 clinical trial?
This trial is open to participants of all sexes, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07732907 currently recruiting?
Yes, NCT07732907 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07732907 trial being conducted?
This trial is being conducted at Lawrenceville, United States.
Who is sponsoring the NCT07732907 clinical trial?
NCT07732907 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 15 participants.
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