Trial Outcomes & Findings for A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants (NCT NCT06476834)

NCT ID: NCT06476834

Last Updated: 2025-12-03

Results Overview

Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

First dose day 1 to day 4 up to 72 hours

Results posted on

2025-12-03

Participant Flow

All participants received study treatment at one site in the United States of America.

Total 8 participants received study medication.

Participant milestones

Participant milestones
Measure	Deucravacitinib 9 mg Participants received Deucravacitinib at a dose of 9 mg once daily
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Age, Continuous	30.5 Years STANDARD_DEVIATION 6.12 • n=3 Participants
Sex: Female, Male Female	8 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants
Race (NIH/OMB) Asian	2 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	1 Participants n=3 Participants
Race (NIH/OMB) White	5 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	211.0 ng/mL Geometric Coefficient of Variation 59.5
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	74.09 ng/mL Geometric Coefficient of Variation 55.7

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	1.00 Hour Interval 1.0 to 3.0
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	6.00 Hour Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: First dose day 1 up to 24 hours post dose

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	1656 h*ng/mL Geometric Coefficient of Variation 54.5
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	1289 h*ng/mL Geometric Coefficient of Variation 58.7

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	1876 h*ng/mL Geometric Coefficient of Variation 57.9
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	1767 h*ng/mL Geometric Coefficient of Variation 61.6

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	78.18 ng/mL Geometric Coefficient of Variation 57.9
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	73.61 ng/mL Geometric Coefficient of Variation 61.6

PRIMARY outcome

Timeframe: From first dose day 1 up to 24 hours post dose

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

AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=6 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	0.05021 mg Geometric Coefficient of Variation 102.8
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	0.03393 mg Geometric Coefficient of Variation 107.1

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=6 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk BMS-986165	0.05395 mg Geometric Coefficient of Variation 106.0
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk BMT-153261	0.04230 mg Geometric Coefficient of Variation 116.8

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 BMS-986165	3.241 Ratio Geometric Coefficient of Variation 50.9
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 BMT-153261	15.76 Ratio Geometric Coefficient of Variation 57.7

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Average Estimated Daily Infant Dose	0.01586 mg/kg/day Geometric Coefficient of Variation 58.8

PRIMARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Average Relative Infant Dose	12.11 Percentage Geometric Coefficient of Variation 53.6

SECONDARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma BMS-986165	62.56 ng/mL Geometric Coefficient of Variation 24.5
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma BMT-153261	4.797 ng/mL Geometric Coefficient of Variation 36.9

SECONDARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma BMS-986165	587.2 h*ng/mL Geometric Coefficient of Variation 26.6
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma BMT-153261	128.3 h*ng/mL Geometric Coefficient of Variation 36.6

SECONDARY outcome

Timeframe: First dose day 1 up to 24 hours post dose

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma BMS-986165	511.0 h*ng/mL Geometric Coefficient of Variation 24.4
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma BMT-153261	81.79 h*ng/mL Geometric Coefficient of Variation 39.6

SECONDARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
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 BMS-986165	575.1 h*ng/mL Geometric Coefficient of Variation 26.9
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 BMT-153261	104.5 h*ng/mL Geometric Coefficient of Variation 52.4

SECONDARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma BMS-986165	2.00 Hour Interval 2.0 to 2.0
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma BMT-153261	6.00 Hour Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: First dose day 1 to day 4 up to 72 hours

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

Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma BMS-986165	24.47 ng/mL Geometric Coefficient of Variation 26.6
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma BMT-153261	5.346 ng/mL Geometric Coefficient of Variation 36.6

SECONDARY outcome

Timeframe: From the dose of study medication through 30 days (assessed for up to 30 days)

Population: All Treated Participants.

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	0 Participants

SECONDARY outcome

Timeframe: From the dose of study medication through 30 days (assessed for up to 30 days)

Population: All Treated Participants.

Blood samples were collected to assess the abnormalities in laboratory parameters.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)	0 Participants

SECONDARY outcome

Timeframe: From the dose of study medication through 30 days (assessed for up to 30 days)

Population: All Treated Participants.

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)	0 Participants

SECONDARY outcome

Timeframe: From the dose of study medication through 30 days (assessed for up to 30 days)

Population: All Treated Participants.

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)	0 Participants

SECONDARY outcome

Timeframe: From the dose of study medication through 30 days (assessed for up to 30 days)

Population: All Treated Participants.

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.

Outcome measures

Outcome measures
Measure	Deucravacitinib 9 mg n=8 Participants Participants received Deucravacitinib at a dose of 9 mg once daily
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)	0 Participants

Adverse Events

Deucravacitinib 9 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER