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

NCT07732907 | Recruiting FDA Drug

• 1 other identifier: IM047-1132
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 .

Conditions

Multiple Sclerosis; Progressive Multifocal Leukoencephalopathy

Keywords

Multiple Sclerosis; MS; Progressive Multifocal Leukoencephalopathy; PML; Ozanimod; Zeposia

Outcome Measures

Primary Outcomes (1)

• Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis

  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.

  Up to 15 years

Secondary Outcomes (1)

• Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category

  Up to 15 years

Study Arms (1)

Ozanimod Cohort

Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy

Drug: Ozanimod

Interventions

Ozanimod DRUG

As per product label

Ozanimod Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with multiple sclerosis who have been treated with ozanimod and have reported potential progressive multifocal leukoencephalopathy events identified through the Bristol Myers Squibb safety database, spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.

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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol Myers Squibb

Lawrenceville, New Jersey, 08648, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Sclerosis; Leukoencephalopathy, Progressive Multifocal

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Leukoencephalopathies; Neuroinflammatory Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): July 31, 2041
• Study Completion (Estimated): July 31, 2041
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)