Recruiting

Ozanimod

Sponsor:

Bristol-Myers Squibb

Code:

NCT07732907

Conditions

Multiple Sclerosis

Progressive Multifocal Leukoencephalopathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ozanimod

Study Details

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

Study ID

NCT07732907

Start date

Jun 4, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2041

Anticipated

Primary completion date

Jul 31, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Ozanimod Cohort

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

Interventions

Ozanimod

As per product label

Primary outcome measure

  • Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Bristol Myers Squibb

Recruiting

Lawrenceville, New Jersey, United States, 08648

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-29.