Lactating WomenPhase 4NCT06181630
A Lactation Study in Women Receiving Treatment With Ozanimod
A Phase 4 study testing Breast milk, plasma, and blood samples in people with Lactating Women and Breastfed Infants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lactating Women, Breastfed Infants
- What is being tested?
- Breast milk, plasma, and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 16 Dec 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
- Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
- Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
- Infant participant has normal weight for gestational age (above tenth percentile) at birth.
Who cannot join
- Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
- Adult participant is not breastfeeding or pumping milk.
- Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
- Infant participant was born less than 37 weeks gestation
- Other protocol-defined criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, 89113-2228
About this study
Official title: A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
- Conditions
- Lactating Women, Breastfed Infants
- Being tested
- Breast milk, plasma, and blood samples
- Keywords
- Ozanimod, BMS-986374
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast milk, plasma, and blood samplesDiagnostic test
Although this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study.
| Study group | Role | What they receive |
|---|---|---|
| Lactating women receiving treatment with Ozanimod and their infants | Experimental | Not described Receives: Diagnostic Test: Breast milk, plasma, and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average concentration at steady state (Css-avg) in breast milk
Measured: Predose; Up to 24 hours post dose
Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk
Measured: Predose; Up to 24 hours post dose
Drug daily infant dose
Measured: Predose; Up to 24 hours post dose
Drug relative infant dose
Measured: Predose; Up to 24 hours post dose
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to approximately 5 months
Number of participants with clinical laboratory abnormalities
Measured: Up to approximately 5 months
Number of participants with vital sign abnormalities
Measured: Up to approximately 5 months
Number of participants with physical examination abnormalities
Measured: Up to approximately 5 months
Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)
Measured: Predose; Up to 12 hours post dose
Maximum observed concentration in breast milk over the dosing interval (Cmax)
Measured: Predose; Up to 24 hours post dose
Minimum observed concentration in breast milk over the dosing interval (Cmin)
Measured: Predose; Up to 24 hours post dose
Time to reach Cmax (Tmax)
Measured: Predose; Up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start15 Nov 2025 (estimated)
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Why it stopped: Replaced with another clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactating WomenStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT06181630
- Sponsor's protocol ID
- IM047-030
- Status last verified
- Nov 2025
- First submitted
- 13 Dec 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
- ClinicalTrials.gov ID
- NCT06181630
- Acronym / sponsor ID
- IM047-030
- Conditions
- Lactating Women, Breastfed Infants
- Keywords
- Ozanimod, BMS-986374
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with another clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 26 Dec 2023 (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 assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating women receiving treatment with Ozanimod and their infants | Experimental | Diagnostic Test: Breast milk, plasma, and blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
- Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
- Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
- Infant participant has normal weight for gestational age (above tenth percentile) at birth.
Key exclusion criteria (5 listed)
- Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
- Adult participant is not breastfeeding or pumping milk.
- Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
- Infant participant was born less than 37 weeks gestation
- Other protocol-defined 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast milk, plasma, and blood samplesAlthough this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study. | Diagnostic test | Lactating women receiving treatment with Ozanimod and their infants |
Primary outcome
Average concentration at steady state (Css-avg) in breast milk
Time frame: Predose; Up to 24 hours post dose
Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk
Time frame: Predose; Up to 24 hours post dose
Drug daily infant dose
Time frame: Predose; Up to 24 hours post dose
Drug relative infant dose
Time frame: Predose; Up to 24 hours post dose
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 5 months
Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 5 months
Number of participants with vital sign abnormalities
Time frame: Up to approximately 5 months
Number of participants with physical examination abnormalities
Time frame: Up to approximately 5 months
Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)
Time frame: Predose; Up to 12 hours post dose
Maximum observed concentration in breast milk over the dosing interval (Cmax)
Time frame: Predose; Up to 24 hours post dose
Minimum observed concentration in breast milk over the dosing interval (Cmin)
Time frame: Predose; Up to 24 hours post dose
Time to reach Cmax (Tmax)
Time frame: Predose; Up to 24 hours post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Breast milk, plasma, and blood samples in people with Lactating Women and Breastfed Infants, run by Bristol-Myers Squibb at 1 site in United States.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average concentration at steady state (Css-avg) in breast milk (time frame: Predose; Up to 24 hours post dose). The study lists 4 primary outcomes in all. 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 2 Dec 2025.