Multiple SclerosisNCT07732907
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
An observational study of Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
- What is being tested?
- Ozanimod
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to 31 Jul 2041
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no additional exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
Bristol Myers Squibb
Lawrenceville, New Jersey, 08648
About this study
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 .
- Being tested
- Ozanimod
- Keywords
- Multiple Sclerosis, MS, Progressive Multifocal Leukoencephalopathy, PML, Ozanimod, Zeposia
- Medical subject headings
- Multiple Sclerosis, Leukoencephalopathy, Progressive Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod Cohort | Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 years
Secondary outcomes (1)
Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category
Incidence rates will be calculated as the number of PML cases divided by estimated person-years of ozanimod exposure and reported as cases per 100,000 person-years with 95% confidence intervals. Incidence rates will be reported overall and by risk factor category, including age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, and anti-John Cunningham virus antibody status within 6 months after ozanimod initiation.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start4 Jun 2026
- Primary completion31 Jul 2041 (estimated)
- Study completion31 Jul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732907
- Sponsor's protocol ID
- IM047-1132
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No