A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

May 14, 2025 updated by: Bristol-Myers Squibb

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata

The purpose of this study is to evaluate the efficacy of deucravacitinib versus placebo at Week 24 and safety and tolerability of deucravacitinib versus placebo in adults with alopecia areata.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Local Institution - 0003
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Local Institution - 0005
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Local Institution - 0015
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Local Institution - 0021
      • Peterborough, Ontario, Canada, K9J 5K2
        • Local Institution - 0009
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Local Institution - 0010
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Local Institution - 0034
      • Québec, Quebec, Canada, G1V 4X7
        • Local Institution - 0027
  • France
      • Nice, France, 06200
        • Local Institution - 0033
      • Paris, France, 75010
        • Local Institution - 0020
  • Japan
      • Hamamatsu-Shi, Japan, 431-3192
        • Local Institution - 0031
      • Koto-Ku, Japan, 136-0075
        • Local Institution - 0028
      • Mitaka-Shi, Japan, 181-8611
        • Local Institution - 0030
      • Shinjuku-Ku, Japan, 160-0023
        • Local Institution - 0029
  • Poland
      • Warsaw, Poland, 02-962
        • Local Institution - 0025
    • DS
      • Wroclaw, DS, Poland, 50-566
        • Local Institution - 0026
  • United States
    • California
      • Santa Monica, California, United States, 90404-2120
        • Local Institution - 0016
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Local Institution - 0036
    • Florida
      • Tampa, Florida, United States, 33624-2038
        • Local Institution - 0018
    • Michigan
      • Clinton Township, Michigan, United States, 48038-1137
        • Local Institution - 0023
    • New York
      • New York, New York, United States, 10029-6501
        • Local Institution - 0024
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516-4061
        • Local Institution - 0019
    • Oregon
      • Portland, Oregon, United States, 97201-5134
        • Local Institution - 0011
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • Local Institution - 0032
    • Texas
      • Austin, Texas, United States, 78759
        • Local Institution - 0012
      • Houston, Texas, United States, 77004-8098
        • Local Institution - 0013
      • San Antonio, Texas, United States, 78213-2250
        • Local Institution - 0014
    • Utah
      • South Jordan, Utah, United States, 84095
        • Local Institution - 0017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented clinical diagnosis of alopecia areata (AA) for at least 6 months.
  • Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth [> 10%] over the last 6 months)
  • SALT score ≥ 50 at Screening and Day 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included.

Exclusion Criteria:

  • Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc.
  • Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score.
  • Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deucravacitinib Dose 1
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Placebo
Placebo was administered.
Experimental: Deucravacitinib Dose 2
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Placebo
Placebo was administered.
Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Placebo
Placebo was administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
Time Frame: Baseline (Day 1) and Week 24
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region [24%], top region [40%], left region [18%] and, right region [18%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.
Baseline (Day 1) and Week 24
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
Time Frame: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection.
From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
Time Frame: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection.
From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
Time Frame: From first dose (Day 1) through Week 24
Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
From first dose (Day 1) through Week 24
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
Time Frame: From Week 25 to Week 52
Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
From Week 25 to Week 52
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
Time Frame: First dose (Day 1) to Week 24
A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements
First dose (Day 1) to Week 24
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
Time Frame: Week 25 to Week 52
A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements
Week 25 to Week 52
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
Time Frame: First dose (Day 1) to Week 24
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes.
First dose (Day 1) to Week 24
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
Time Frame: Week 25 to Week 52
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes.
Week 25 to Week 52
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Time Frame: First dose (Day 1) to Week 24
Participants were assessed for abnormalities in targeted physical parameters.
First dose (Day 1) to Week 24
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Time Frame: Week 25 to Week 52
Participants were assessed for abnormalities in targeted physical parameters.
Week 25 to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24
Time Frame: Baseline (Day 1) and Week 24
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region [24%], Left Region [18%], Right Region [18%], Top Region [40%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. SALT50 response indicates at least a 50% improvement from baseline in the SALT score at a particular time point, indicating 50% hair regrowth.
Baseline (Day 1) and Week 24
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
Time Frame: Baseline (Day 1) and Week 24
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region [24%], Left Region [18%], Right Region [18%], Top Region [40%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. percentage of participants achieving an absolute SALT score ≤ 20, indicates ≤ 20% scalp hair loss.
Baseline (Day 1) and Week 24
Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 With at Least a 2-Point Change From Baseline
Time Frame: Baseline (Day 1) and week 24
The AA-IGA utilizes a 5-points scale, in which the investigator assesses scalp hair loss based on the SALT assessment. The AA-IGA measures alopecia areata severity at a single point in time(without taking into account the baseline disease condition).The participant's scalp hair loss, as it look at the time of evaluation is scored as none (0) (0% scalp hair loss), limited (1) (1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp hair loss), or very severe (4)(95%-100 % scalp hair loss).
Baseline (Day 1) and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-134
  • U1111-1246-1767 (Registry Identifier: WHO)
  • 2020-000113-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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