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

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: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Deucravacitinib; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period	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	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	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	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	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	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	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	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	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	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	Participants were assessed for abnormalities in targeted physical parameters.	Week 25 to Week 52

Secondary Outcome Measures

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	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	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	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

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): January 6, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Deucravacitinib; BMS-986165; IM011134
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID 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