Multiple SclerosisNCT05170126
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
An observational study of Multiple Sclerosis, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,182 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Jul 2022to 30 Jun 2032
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Child, Adult, Older adult
Study population: The study population will include pregnant women of any age who reside in the United States, Canada or Germany.
Who may be able to join
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
Who cannot join
- Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain the NCT# and Site #. contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Evidera INC.
Bethesda, Maryland, 20814
Marielle Bassel, Site 0003
- Recruiting
Evidera
Bethesda, Maryland, 20814
Marielle Bassel, Site 0001
Germany1 site, 1 recruiting
- Recruiting
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Herne, 44625
Kerstin Hellwig, Site 0002, +49 (0)234 509-3920
About this study
Official title: ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Ozanimod, Pregnancy, Outcomes, Obstetric, Infant
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod-exposed participants | Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window. | |
| Comparator-exposed participants | Women with a diagnosis of MS who are not exposed to ozanimod or other sphingosine 1-phosphate (S1P) therapies during the exposure window but who are exposed to other products approved to treat MS during the exposure window. | |
| Unexposed participants | Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major congenital malformations
Measured: Up to first year of life
Secondary outcomes (14)
Minor congenital malformations
Measured: Up to first year of life
Pre-eclampsia
Measured: Through pregnancy
Eclampsia
Measured: Through pregnancy
Spontaneous abortion
Measured: Through pregnancy
Stillbirth
Measured: Through pregnancy
Elective termination
Measured: Through pregnancy
Preterm birth
Measured: Through pregnancy
Small for gestational age
Measured: Up to first year of life
Postnatal growth deficiency
Measured: Up to first year of life
Infant developmental deficiency
Measured: Up to first year of life
Perinatal death
Measured: Up to first year of life
Neonatal death
Measured: Up to first year of life
Infant death
Measured: Up to first year of life
Serious or opportunistic infant infection (SOI)
Measured: Up to first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start15 Jul 2022
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (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
- 1,182 participants (estimated)
- Target duration
- 12 Months
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
- NCT05170126
- Sponsor's protocol ID
- IM047-003
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT05170126
- Acronym / sponsor ID
- IM047-003
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Ozanimod, Pregnancy, Outcomes, Obstetric, Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,182 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozanimod-exposed participants | – | –Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window. |
| Comparator-exposed participants | – | –Women with a diagnosis of MS who are not exposed to ozanimod or other sphingosine 1-phosphate (S1P) therapies during the exposure window but who are exposed to other products approved to treat MS during the exposure window. |
| Unexposed participants | – | –Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women of any age who reside in the United States, Canada or Germany.
Key inclusion criteria (3 listed)
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
Key exclusion criteria (2 listed)
- Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major congenital malformations
Time frame: Up to first year of life
14 secondary outcomes
Minor congenital malformations
Time frame: Up to first year of life
Pre-eclampsia
Time frame: Through pregnancy
Eclampsia
Time frame: Through pregnancy
Spontaneous abortion
Time frame: Through pregnancy
Stillbirth
Time frame: Through pregnancy
Elective termination
Time frame: Through pregnancy
Preterm birth
Time frame: Through pregnancy
Small for gestational age
Time frame: Up to first year of life
Postnatal growth deficiency
Time frame: Up to first year of life
Infant developmental deficiency
Time frame: Up to first year of life
Perinatal death
Time frame: Up to first year of life
Neonatal death
Time frame: Up to first year of life
Infant death
Time frame: Up to first year of life
Serious or opportunistic infant infection (SOI)
Time frame: Up to first year of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of the email MUST contain the NCT# and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bristol-Myers Squibb at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformations (time frame: Up to first year of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.