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Phase 4 N=8 Treatment

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

Healthy Volunteers

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk — 211.0; 74.09 ng/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Deucravacitinib (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Bristol-Myers Squibb
Primary completion
Nov 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk
211.0; 74.09
PRIMARY
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk
1.00; 6.00
PRIMARY
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk
1656; 1289
PRIMARY
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk
1876; 1767
PRIMARY
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk
78.18; 73.61
PRIMARY
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk
0.05021; 0.03393
PRIMARY
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk
0.05395; 0.04230
PRIMARY
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261
3.241; 15.76
PRIMARY
Average Estimated Daily Infant Dose
0.01586
PRIMARY
Average Relative Infant Dose
12.11
SECONDARY
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma
62.56; 4.797
SECONDARY
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma
587.2; 128.3
SECONDARY
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma
511.0; 81.79
SECONDARY
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
575.1; 104.5
SECONDARY
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma
2.00; 6.00
SECONDARY
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma
24.47; 5.346
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
SECONDARY
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
SECONDARY
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
SECONDARY
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)
SECONDARY
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06476834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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