Back to resultsA Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Deucravacitinib, IM011134, BMS-986165
Eligibility Criteria
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.
Sites / Locations
- Local Institution - 0016
- Local Institution - 0036
- Local Institution - 0018
- Local Institution - 0023
- Local Institution - 0019
- Local Institution - 0011
- Local Institution - 0012
- Local Institution - 0013
- Local Institution - 0014
- Local Institution - 0017
- Local Institution - 0003
- Local Institution - 0005
- Local Institution - 0015
- Local Institution - 0021
- Local Institution - 0009
- Local Institution - 0010
- Local Institution - 0034
- Local Institution - 0027
- Local Institution - 0033
- Local Institution - 0020
- Local Institution - 0031
- Local Institution - 0028
- Local Institution - 0030
- Local Institution - 0029
- Local Institution - 0026
- Local Institution - 0025
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Deucravacitinib Dose 1
Deucravacitinib Dose 2
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Adverse Events (AEs)
Number of Participants with AEs Leading to Study Discontinuation
Number of Participants with AEs of Interest (AEIs)
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of Participants with Physical Examination Abnormalities
Number of Participants with Vital Sign Abnormalities
Secondary Outcome Measures
Proportion of participants with a ≥ 50% reduction in SALT Score (SALT50 Response) from Baseline at Week 24
Proportion of Participants with a SALT Score ≤ 20 at Week 24
Proportion of Participants with 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
Full Information
NCT ID
NCT05556265
First Posted
September 23, 2022
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05556265
Brief Title
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
September 16, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Deucravacitinib, IM011134, BMS-986165
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deucravacitinib Dose 1
Arm Type
Experimental
Arm Title
Deucravacitinib Dose 2
Arm Type
Experimental
Arm Title
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Other Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Change from Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Time Frame
Baseline, Week 24
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Baseline up to Week 56
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Baseline up to Week 56
Title
Number of Participants with AEs Leading to Study Discontinuation
Time Frame
Baseline up to Week 56
Title
Number of Participants with AEs of Interest (AEIs)
Time Frame
Baseline up to Week 56
Title
Number of Participants with Clinical Laboratory Abnormalities
Time Frame
Baseline up to Week 56
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Baseline up to Week 56
Title
Number of Participants with Physical Examination Abnormalities
Time Frame
Baseline up to Week 56
Title
Number of Participants with Vital Sign Abnormalities
Time Frame
Baseline up to Week 56
Secondary Outcome Measure Information:
Title
Proportion of participants with a ≥ 50% reduction in SALT Score (SALT50 Response) from Baseline at Week 24
Time Frame
Week 24
Title
Proportion of Participants with a SALT Score ≤ 20 at Week 24
Time Frame
Week 24
Title
Proportion of Participants with 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
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0016
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2120
Country
United States
Facility Name
Local Institution - 0036
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Local Institution - 0018
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624-2038
Country
United States
Facility Name
Local Institution - 0023
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038-1137
Country
United States
Facility Name
Local Institution - 0019
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516-4061
Country
United States
Facility Name
Local Institution - 0011
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223-6683
Country
United States
Facility Name
Local Institution - 0012
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Local Institution - 0013
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8098
Country
United States
Facility Name
Local Institution - 0014
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213-2250
Country
United States
Facility Name
Local Institution - 0017
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Local Institution - 0003
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution - 0005
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Local Institution - 0015
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Local Institution - 0021
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Local Institution - 0009
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Local Institution - 0010
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Local Institution - 0034
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Local Institution - 0027
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Local Institution - 0033
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution - 0020
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution - 0031
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
4313192
Country
Japan
Facility Name
Local Institution - 0028
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Local Institution - 0030
City
Mitaka-Shi
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution - 0029
City
Shinjuku-Ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Local Institution - 0026
City
Wroclaw
State/Province
DS
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Local Institution - 0025
City
Warsaw
ZIP/Postal Code
02-962
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
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