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CompletedNCT06476834Updated Dec 3, 2025Results posted

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

A Phase 4 interventional study of Deucravacitinib in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Deucravacitinib Administration

    Drug: Deucravacitinib

Interventions

  • DrugDeucravacitinib

    Specified dose on specified days

    Also known as: BMS-986165, SOTYKTU®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  2. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  3. 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.

    Time frame: First dose day 1 up to 24 hours post dose

  4. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  5. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  6. 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.

    Time frame: From first dose day 1 up to 24 hours post dose

  7. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  8. Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261

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

    Time frame: First dose day 1 to day 4 up to 72 hours

  9. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  10. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

Secondary outcomes

  1. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  2. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  3. 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.

    Time frame: First dose day 1 up to 24 hours post dose

  4. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  5. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  6. 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.

    Time frame: First dose day 1 to day 4 up to 72 hours

  7. 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.

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

  8. Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)

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

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

07

Results

Posted Dec 3, 2025

Participant flow

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

Participant flow — Overall Study
MilestoneDeucravacitinib 9 mg
Started8
Completed8
Not completed0

Outcome measures

PrimaryMaximum 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk
ng/mLDeucravacitinib 9 mg
BMS-986165211.0 ± 59.5
BMT-15326174.09 ± 55.7
PrimaryTime 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Median · Hour
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk
HourDeucravacitinib 9 mg
BMS-9861651.00 (1.00 to 3.00)
BMT-1532616.00 (3.00 to 6.00)
PrimaryArea 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.

Time frame:
First dose day 1 up to 24 hours post dose
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk
h*ng/mLDeucravacitinib 9 mg
BMS-9861651656 ± 54.5
BMT-1532611289 ± 58.7
PrimaryArea 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk
h*ng/mLDeucravacitinib 9 mg
BMS-9861651876 ± 57.9
BMT-1532611767 ± 61.6
PrimaryAverage 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · ng/mL
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk
ng/mLDeucravacitinib 9 mg
BMS-98616578.18 ± 57.9
BMT-15326173.61 ± 61.6
PrimaryAmount 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.

Time frame:
From first dose day 1 up to 24 hours post dose
Reported as:
Geometric mean · mg
Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk
mgDeucravacitinib 9 mg
BMS-9861650.05021 ± 102.8
BMT-1532610.03393 ± 107.1
PrimaryTotal 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · mg
Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk
mgDeucravacitinib 9 mg
BMS-9861650.05395 ± 106.0
BMT-1532610.04230 ± 116.8
PrimaryMilk-plasma Ratio (M/P) of BMS-986165 and BMT-153261

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

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · Ratio
Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261
RatioDeucravacitinib 9 mg
BMS-9861653.241 ± 50.9
BMT-15326115.76 ± 57.7
PrimaryAverage 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · mg/kg/day
Average Estimated Daily Infant Dose
mg/kg/dayDeucravacitinib 9 mg
Average Estimated Daily Infant Dose0.01586 ± 58.8
PrimaryAverage 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · Percentage
Average Relative Infant Dose
PercentageDeucravacitinib 9 mg
Average Relative Infant Dose12.11 ± 53.6
SecondaryMaximum 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma
ng/mLDeucravacitinib 9 mg
BMS-98616562.56 ± 24.5
BMT-1532614.797 ± 36.9
SecondaryArea 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma
h*ng/mLDeucravacitinib 9 mg
BMS-986165587.2 ± 26.6
BMT-153261128.3 ± 36.6
SecondaryArea 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.

Time frame:
First dose day 1 up to 24 hours post dose
Reported as:
Geometric mean · h*ng/mL
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma
h*ng/mLDeucravacitinib 9 mg
BMS-986165511.0 ± 24.4
BMT-15326181.79 ± 39.6
SecondaryArea 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · h*ng/mL
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
h*ng/mLDeucravacitinib 9 mg
BMS-986165575.1 ± 26.9
BMT-153261104.5 ± 52.4
SecondaryTime 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Median · Hour
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma
HourDeucravacitinib 9 mg
BMS-9861652.00 (2.00 to 2.00)
BMT-1532616.00 (6.00 to 10.0)
SecondaryAverage 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.

Time frame:
First dose day 1 to day 4 up to 72 hours
Reported as:
Geometric mean · ng/mL
Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma
ng/mLDeucravacitinib 9 mg
BMS-98616524.47 ± 26.6
BMT-1532615.346 ± 36.6
SecondaryNumber 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.

Time frame:
From the dose of study medication through 30 days (assessed for up to 30 days)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDeucravacitinib 9 mg
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)0
SecondaryNumber of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)

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

Time frame:
From the dose of study medication through 30 days (assessed for up to 30 days)
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDeucravacitinib 9 mg
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)0
SecondaryNumber 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.

Time frame:
From the dose of study medication through 30 days (assessed for up to 30 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDeucravacitinib 9 mg
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)0
SecondaryNumber 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.

Time frame:
From the dose of study medication through 30 days (assessed for up to 30 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDeucravacitinib 9 mg
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)0
SecondaryNumber 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.

Time frame:
From the dose of study medication through 30 days (assessed for up to 30 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDeucravacitinib 9 mg
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)0

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Deucravacitinib 9 mg0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Deucravacitinib 9 mg
Mean30.5 ± 6.12
Sex: Female, Male
Sex: Female, Male(Participants)Deucravacitinib 9 mg
Female8
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Deucravacitinib 9 mg
Hispanic or Latino3
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Deucravacitinib 9 mg
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White5
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Local Institution - 0001
    Las Vegas, Nevada 89113-2246, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 3, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06476834
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 24, 2024
Primary completion
Nov 2, 2024
Completion
Nov 2, 2024
Results posted
Dec 3, 2025
Last update
Dec 3, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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