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

NCT05556265 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM011-134U1111-1246-17672020-000113-33
• Study Type: interventional
• Target: 94
• Locations: 6 countries
• Sites: 28

Brief Summary

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.

Conditions

Alopecia Areata

Keywords

Deucravacitinib; IM011134; BMS-986165

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24

  Baseline (Day 1) and Week 24

• Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24

  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

  Baseline (Day 1) and week 24

Study Arms (3)

Deucravacitinib Dose 1

EXPERIMENTAL

Drug: Deucravacitinib; Other: Placebo

Deucravacitinib Dose 2

EXPERIMENTAL

Drug: Deucravacitinib; Other: Placebo

Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Deucravacitinib Dose 1; Deucravacitinib Dose 2; Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

Placebo OTHER

Placebo was administered.

Deucravacitinib Dose 1; Deucravacitinib Dose 2; Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (28)

Local Institution - 0016

Santa Monica, California, 90404-2120, United States

Location

Local Institution - 0036

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0018

Tampa, Florida, 33624-2038, United States

Location

Local Institution - 0023

Clinton Township, Michigan, 48038-1137, United States

Location

Local Institution - 0024

New York, New York, 10029-6501, United States

Location

Local Institution - 0019

Chapel Hill, North Carolina, 27516-4061, United States

Location

Local Institution - 0011

Portland, Oregon, 97201-5134, United States

Location

Local Institution - 0032

Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Local Institution - 0012

Austin, Texas, 78759, United States

Location

Local Institution - 0013

Houston, Texas, 77004-8098, United States

Location

Local Institution - 0014

San Antonio, Texas, 78213-2250, United States

Location

Local Institution - 0017

South Jordan, Utah, 84095, United States

Location

Local Institution - 0003

Kogarah, New South Wales, 2217, Australia

Location

Local Institution - 0005

Carlton, Victoria, 3053, Australia

Location

Local Institution - 0015

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Local Institution - 0021

Markham, Ontario, L3P 1X2, Canada

Location

Local Institution - 0009

Peterborough, Ontario, K9J 5K2, Canada

Location

Local Institution - 0010

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Local Institution - 0034

Montreal, Quebec, H2X 2V1, Canada

Location

Local Institution - 0027

Québec, Quebec, G1V 4X7, Canada

Location

Local Institution - 0033

Nice, 06200, France

Location

Local Institution - 0020

Paris, 75010, France

Location

Local Institution - 0031

Hamamatsu, 431-3192, Japan

Location

Local Institution - 0028

Kōtoku, 136-0075, Japan

Location

Local Institution - 0030

Mitaka-Shi, 181-8611, Japan

Location

Local Institution - 0029

Shinjuku-Ku, 160-0023, Japan

Location

Local Institution - 0026

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Local Institution - 0025

Warsaw, 02-962, Poland

Location

Related Links

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

MeSH Terms

Conditions

Alopecia Areata

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: November 8, 2022
• Primary Completion: January 6, 2024
• Study Completion: May 16, 2024
• Last Updated: May 31, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-05

Data Sharing

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

Locations

JP (4); FR (2); PL (2); US (12); AU (2); CA (6)