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

NCT06476834 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IM011-1123
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  First dose day 1 to day 4 up to 72 hours

Study Arms (1)

Deucravacitinib Administration

EXPERIMENTAL

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165, SOTYKTU®

Deucravacitinib Administration

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Las Vegas, Nevada, 89113-2246, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

deucravacitinib

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 24, 2024
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)