Healthy VolunteersPhase 4NCT06476834

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

A Phase 4 study testing Deucravacitinib in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Deucravacitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2024to 2 Nov 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations.
Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected.
Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).

Who cannot join

Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study.
Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention.
Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts.
History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Local Institution - 0001
Las Vegas, Nevada, 89113-2246

Other trials in United States

About this study

Official title: A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.

Conditions: Healthy Volunteers
Being tested: Deucravacitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeucravacitinibDrug
Also called BMS-986165, SOTYKTU®
Specified dose on specified days

Study groups in NCT06476834
Study group	Role	What they receive
Deucravacitinib Administration	Experimental	Not described Receives: Drug: Deucravacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk
Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 to day 4 up to 72 hours
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk
Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 to day 4 up to 72 hours
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk
AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 up to 24 hours post dose
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk
AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 to day 4 up to 72 hours
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk
Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 to day 4 up to 72 hours
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk
AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.
Measured: From first dose day 1 up to 24 hours post dose
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk
AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.
Measured: First dose day 1 to day 4 up to 72 hours
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261
M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.
Measured: First dose day 1 to day 4 up to 72 hours
Average Estimated Daily Infant Dose
Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data.
Measured: First dose day 1 to day 4 up to 72 hours
Average Relative Infant Dose
Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data.
Measured: First dose day 1 to day 4 up to 72 hours

Secondary outcomes (11)

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma
Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 to day 4 up to 72 hours
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma
AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 to day 4 up to 72 hours
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma
AUC(0-24) defined as the area under the plasma concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 up to 24 hours post dose
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma
AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 to day 4 up to 72 hours
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma
Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 to day 4 up to 72 hours
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma
Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma.
Measured: First dose day 1 to day 4 up to 72 hours
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood samples were collected to assess the abnormalities in laboratory parameters.
Measured: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: From the dose of study medication through 30 days (assessed for up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 20242 Nov 2024

First posted26 Jun 2024
Study start24 Jun 2024
Primary completion2 Nov 2024
Study completion2 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06476834
Sponsor's protocol ID: IM011-1123
Status last verified: Nov 2025
First submitted: 21 Jun 2024
Last updated: 3 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
ClinicalTrials.gov ID: NCT06476834
Acronym / sponsor ID: IM011-1123
Conditions: Healthy Volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 24 Jun 2024 (actual)
Primary completion: 2 Nov 2024 (actual)
Study completion: 2 Nov 2024 (actual)
First posted: 26 Jun 2024 (actual)
Results: Posted 3 Dec 2025

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 evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Deucravacitinib Administration	Experimental	Drug: Deucravacitinib

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations.
Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected.
Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).

Key exclusion criteria (5 listed)

Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study.
Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention.
Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts.
History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary.
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.

Interventions

Intervention	Type	Arms
DeucravacitinibAlso: BMS-986165, SOTYKTU®Specified dose on specified days	Drug	Deucravacitinib Administration

Primary outcome

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 to day 4 up to 72 hours
Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 to day 4 up to 72 hours
Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 up to 24 hours post dose
AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 to day 4 up to 72 hours
AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk.
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 to day 4 up to 72 hours
Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk
Time frame: From first dose day 1 up to 24 hours post dose
AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk
Time frame: First dose day 1 to day 4 up to 72 hours
AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261
Time frame: First dose day 1 to day 4 up to 72 hours
M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.
Average Estimated Daily Infant Dose
Time frame: First dose day 1 to day 4 up to 72 hours
Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data.
Average Relative Infant Dose
Time frame: First dose day 1 to day 4 up to 72 hours
Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data.

11 secondary outcomes

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 to day 4 up to 72 hours
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 to day 4 up to 72 hours
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 up to 24 hours post dose
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 to day 4 up to 72 hours
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 to day 4 up to 72 hours
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma
Time frame: First dose day 1 to day 4 up to 72 hours
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

Results and safety

Results posted to the registry on 3 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deucravacitinib 9 mg	8	8

Primary outcome: Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk

Time frame: First dose day 1 to day 4 up to 72 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Deucravacitinib 9 mg n = 8
BMS-986165	211.0 (59.5)
BMT-153261	74.09 (55.7)

Population analysed: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.

Primary outcome: Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk

Time frame: First dose day 1 to day 4 up to 72 hours. Median (Full Range). Unit: Hour

Measure	Deucravacitinib 9 mg n = 8
BMS-986165	1.00 (1.00 to 3.00)
BMT-153261	6.00 (3.00 to 6.00)

Population analysed: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.

Primary outcome: Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk

Time frame: First dose day 1 up to 24 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Deucravacitinib 9 mg n = 8
BMS-986165	1656 (54.5)
BMT-153261	1289 (58.7)

Population analysed: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.

Primary outcome: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk

Time frame: First dose day 1 to day 4 up to 72 hours. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Deucravacitinib 9 mg n = 8
BMS-986165	1876 (57.9)
BMT-153261	1767 (61.6)

Population analysed: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for All-Cause Mortality, SAEs and Other AEs from the dose of study medication through 30 days (assessed for up to 30 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deucravacitinib 9 mg	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.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 Deucravacitinib in people with Healthy Volunteers, 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: finished, as of the sponsor's last update on 3 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?

Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk (time frame: First dose day 1 to day 4 up to 72 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476834.

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 3 Dec 2025.