A Study to Evaluate Efficacy and Safety of Deucravacitini... | NCT05556265 | Trialant
NCT05556265
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
May 31, 2025Actual
Enrollment
94Actual
Phase
Phase 2
Conditions
Alopecia Areata
Interventions
Deucravacitinib
Placebo
Countries
United States
Australia
Canada
France
Japan
Poland
Protocol Section
Identification Module
NCT ID
NCT05556265
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-134
Secondary IDs
ID
Type
Description
Link
U1111-1246-1767
Registry Identifier
WHO
2020-000113-33
EudraCT Number
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
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business objectives have changed
Expanded Access Info
No
Start Date
Nov 8, 2022Actual
Primary Completion Date
Jan 6, 2024Actual
Completion Date
May 16, 2024Actual
First Submitted Date
Sep 23, 2022
First Submission Date that Met QC Criteria
Sep 23, 2022
First Posted Date
Sep 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2024
Results First Submitted that Met QC Criteria
Feb 8, 2025
Results First Posted Date
Feb 28, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2025
Last Update Posted Date
May 31, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia Areata
Keywords
Deucravacitinib
IM011134
BMS-986165
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
94Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Name
Type
Description
Arm Group Labels
Other Names
Deucravacitinib
Drug
Specified dose on specified days
Deucravacitinib Dose 1
Deucravacitinib Dose 2
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Outcomes Module
Primary Outcomes
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.
Secondary Outcomes
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.
Other Outcomes
Not provided
Eligibility Module
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.
94 participants randomized and treated in Placebo controlled period. the 31 participants in the placebo cohort, were re-randomized into the active treatment cohort.
Recruitment Details
Study was terminated due to change in business objectives.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
FG001
Deucravacitinib 6 mg BID
Periods
Title
Milestones
Reasons Not Completed
Placebo-Controlled (Day 1 to Week 24)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 29, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantCare Provider
BMS-986165
Placebo
Other
Placebo was administered.
Deucravacitinib Dose 1
Deucravacitinib Dose 2
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
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
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).
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
FG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
FG003
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
FG004
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
FG00032 subjects
FG00131 subjects
FG00231 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00032 subjects
FG00126 subjects
FG00231 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0000 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Participant request to discontinue study treatment
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Active Treatment (Week 25 to Week 52)
Type
Comment
Milestone Data
STARTED
FG00032 subjects
FG00126 subjects
FG0020 subjects
FG00316 subjects16 out of 31 participants from Placebo arm (Placebo-controlled Period) re-randomized to this arm in Active Treatment period.
FG00415 subjects15 out of 31 participants from Placebo arm (Placebo-controlled Period) re-randomized to this arm in Active Treatment Period.
COMPLETED
FG0008 subjects
FG0015 subjects
FG0020 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG00024 subjects
FG00121 subjects
FG0020 subjects
FG00311 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
BG001
Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
BG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00131
BG00231
BG00394
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.1± 13.37
BG00143.4± 13.81
BG00238.9± 14.40
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00122
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (Day 1) and Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG000-5.809± 13.3892
OG0011.027± 14.7258
OG002-7.302± 17.8732
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
ID
Title
Description
OG000
Active Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in placebo-controlled period continued on their assigned dosage in Active Treatment Period till Week 52.
OG001
Active Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From first dose (Day 1) through Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
From Week 25 to Week 52
ID
Title
Description
OG000
Active Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG001
Active Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG002
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Primary
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
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with ECG measurements at specified timepoints are included in the analysis.
Posted
Count of Participants
Participants
First dose (Day 1) to Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Primary
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
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with ECG measurements at specified timepoints are included in the analysis.
Posted
Count of Participants
Participants
Week 25 to Week 52
ID
Title
Description
OG000
Active Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG001
Active Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG002
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with vital sign measurements at specified timepoints are included in the analysis.
Posted
Count of Participants
Participants
First dose (Day 1) to Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Primary
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.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with vital sign measurements at specified timepoints are included in the analysis.
Posted
Count of Participants
Participants
Week 25 to Week 52
ID
Title
Description
OG000
Active Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG001
Active Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG002
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Secondary
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.
Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
Posted
Number
Percentage of participants
Baseline (Day 1) and Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Secondary
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.
Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
Posted
Number
Percentage of participants
Baseline (Day 1) and Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Secondary
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).
Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
Posted
Number
Percentage of participants
Baseline (Day 1) and week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Primary
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Participants were assessed for abnormalities in targeted physical parameters.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
First dose (Day 1) to Week 24
ID
Title
Description
OG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
OG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Primary
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Participants were assessed for abnormalities in targeted physical parameters.
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Week 25 to Week 52
ID
Title
Description
OG000
Active Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG001
Active Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
OG002
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
Time Frame
All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Description
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo-Controlled: Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
0
32
1
32
24
32
EG001
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
0
31
1
31
26
31
EG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
0
31
0
31
16
31
EG003
Active-Treatment Period: Deucravacitinib 6 mg QD
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
0
32
0
32
15
32
EG004
Active-Treatment Period: Deucravacitinib 6 mg BID
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
0
26
1
26
14
26
EG005
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib QD tablet orally till Week 52 in Active Treatment Period.
0
16
0
16
13
16
EG006
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
0
15
0
15
14
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Viral upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG0030 affected32 at risk
EG004
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Nodular lymphocyte predominant Hodgkin Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG0030 affected32 at risk
EG0040 affected26 at risk
EG0051 affected16 at risk
EG0060 affected15 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Amalgam tattoo
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected32 at risk
EG0014 affected31 at risk
EG0021 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0014 affected31 at risk
EG0020 affected31 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Mass
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected31 at risk
EG0022 affected31 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0005 affected32 at risk
EG0016 affected31 at risk
EG0021 affected31 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Nail infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0005 affected32 at risk
EG0018 affected31 at risk
EG0020 affected31 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected31 at risk
EG0022 affected31 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0014 affected31 at risk
EG0024 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 affected31 at risk
EG0020 affected31 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected31 at risk
EG0021 affected31 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected31 at risk
EG0020 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected32 at risk
EG0013 affected31 at risk
EG0023 affected31 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected31 at risk
EG0021 affected31 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0005 affected32 at risk
EG0014 affected31 at risk
EG0023 affected31 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected31 at risk
EG0020 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected31 at risk
EG0021 affected31 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected31 at risk
EG0022 affected31 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected31 at risk
EG0020 affected31 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Participant request to discontinue study treatment
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Study terminated by sponsor
FG00019 subjects
FG00112 subjects
FG0020 subjects
FG0036 subjects
FG0049 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
39.4
± 14.04
20
BG00364
Male
BG00010
BG0019
BG00211
BG00330
0
BG0034
Not Hispanic or Latino
BG00031
BG00128
BG00231
BG00390
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
0
BG0030
Asian
BG0008
BG0016
BG00210
BG00324
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0001
BG0014
BG0022
BG0037
White
BG00022
BG00120
BG00219
BG00361
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0001
BG0011
BG0020
BG0032
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Treatment Emergent Adverse Events
Title
Measurements
OG00025
OG00128
OG00220
Serious Treatment Emergent Adverse Events
Title
Measurements
OG0001
OG0011
OG0020
Treatment Emergent Adverse Events Leading to Discontinuation of Study
Title
Measurements
OG0001
OG0013
OG0020
TEAE of Interest-Herpes Zoster
Title
Measurements
OG0001
OG0010
OG0020
TEAE of Interest-Malignancy-Bowen's Disease)
Title
Measurements
OG0000
OG0011
OG0020
TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma
Title
Measurements
OG0000
OG0011
OG0020
TEAE of Interest - Opportunistic Infections
Title
Measurements
OG0000
OG0010
OG0020
TEAE of Interest - Tuberculosis Infection
Title
Measurements
OG0000
OG0010
OG0020
OG002
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
OG003
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
Units
Counts
Participants
OG00032
OG00126
OG00216
OG00315
Title
Denominators
Categories
Treatment Emergent Adverse Events
Title
Measurements
OG00021
OG00117
OG00213
OG00314
Serious Treatment Emergent Adverse Events
Title
Measurements
OG0000
OG0011
OG0020
OG003
Treatment Emergent Adverse Events Leading to Discontinuation of Study
Title
Measurements
OG0001
OG0010
OG0021
OG003
TEAE of Interest-Herpes Zoster
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAE of Interest-Malignancy-Bowen's Disease
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAE of Interest - Opportunistic Infections
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAE of Interest - Tuberculosis Infection
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
HEMOGLOBIN, LOW
Title
Measurements
OG0000
OG0010
OG0020
PLATELET COUNT, LOW
Title
Measurements
OG0000
OG0010
OG0020
LEUKOCYTES, LOW
Title
Measurements
OG0000
OG0010
OG0020
ALANINE AMINOTRANSFERASE (ALT), HIGH
Title
Measurements
OG0000
OG0010
OG0020
ALKALINE PHOSPHATASE (ALP), HIGH
Title
Measurements
OG0000
OG0010
OG0020
ASPARTATE AMINOTRANSFERASE (AST), HIGH
Title
Measurements
OG0000
OG0010
OG0020
BILIRUBIN, TOTAL, HIGH
Title
Measurements
OG0000
OG0010
OG0020
CREATININE, ENZYMATIC, HIGH
Title
Measurements
OG0000
OG0010
OG0020
ALBUMIN, LOW
Title
Measurements
OG0000
OG0010
OG0020
CALCIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
CALCIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
CHOLESTEROL, TOTAL (TC), HIGH
Title
Measurements
OG0000
OG0010
OG0020
CREATINE KINASE (CK), HIGH
Title
Measurements
OG0000
OG0011
OG0022
GLUCOSE, LOW
Title
Measurements
OG0000
OG0010
OG0020
POTASSIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
POTASSIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
SODIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
SODIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
TRIGLYCERIDES, HIGH
Title
Measurements
OG0000
OG0010
OG0020
GLUCOSE FASTING, LOW
Title
Measurements
OG0000
OG0010
OG0020
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
OG003
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
Units
Counts
Participants
OG00032
OG00126
OG00216
OG00315
Title
Denominators
Categories
HEMOGLOBIN, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG0030
PLATELET COUNT, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
LEUKOCYTES, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALANINE AMINOTRANSFERASE (ALT), HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALKALINE PHOSPHATASE (ALP), HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
ASPARTATE AMINOTRANSFERASE (AST), HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
BILIRUBIN, TOTAL, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREATININE, ENZYMATIC, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALBUMIN, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
CALCIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
CALCIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
CHOLESTEROL, TOTAL (TC), HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREATINE KINASE (CK), HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
GLUCOSE, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
POTASSIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
POTASSIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
SODIUM, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
SODIUM, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
TRIGLYCERIDES, HIGH
Title
Measurements
OG0000
OG0010
OG0020
OG003
GLUCOSE FASTING, LOW
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00032
OG00129
OG00231
Title
Denominators
Categories
QTCF 450 -< 480 MILLISECONDS (MSEC)
Title
Measurements
OG0000
OG0012
OG0021
QTCF 480 -< 500 MSEC
Title
Measurements
OG0000
OG0010
OG0020
QTCF >= 500 MSEC
Title
Measurements
OG0000
OG0010
OG0020
QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
Title
Measurements
OG0000
OG0011
OG0020
QTCF CHANGE FROM BASELINE > 60 MSEC
Title
Measurements
OG0000
OG0010
OG0020
PR INTERVAL >= 200 MSEC
Title
Measurements
OG0002
OG0010
OG0021
QRS INTERVAL >= 120 MSEC
Title
Measurements
OG0000
OG0010
OG0021
OG003
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
Units
Counts
Participants
OG00028
OG00119
OG00214
OG00314
Title
Denominators
Categories
QTCF 450 -< 480 MILLISECONDS (MSEC)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
QTCF 480 -< 500 MSEC
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF >= 500 MSEC
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
Title
Measurements
OG0001
OG0011
OG0021
OG003
QTCF CHANGE FROM BASELINE > 60 MSEC
Title
Measurements
OG0000
OG0010
OG0020
OG003
PR INTERVAL >= 200 MSEC
Title
Measurements
OG0001
OG0010
OG0021
OG003
QRS INTERVAL >= 120 MSEC
Title
Measurements
OG0001
OG0010
OG0021
OG003
Units
Counts
Participants
OG00032
OG00130
OG00231
Title
Denominators
Categories
HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM
Title
Measurements
OG0000
OG0011
OG0020
HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM
Title
Measurements
OG0001
OG0010
OG0020
SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG
Title
Measurements
OG0001
OG0014
OG0021
SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG
Title
Measurements
OG0000
OG0010
OG0021
DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG
Title
Measurements
OG0003
OG0010
OG0021
DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG
Title
Measurements
OG0000
OG0010
OG0021
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
OG003
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
Units
Counts
Participants
OG00032
OG00126
OG00216
OG00315
Title
Denominators
Categories
HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM
Title
Measurements
OG0000
OG0010
OG0020
OG0031
HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM
Title
Measurements
OG0001
OG0011
OG0020
OG003
SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG
Title
Measurements
OG0001
OG0011
OG0020
OG003
SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG
Title
Measurements
OG0000
OG0010
OG0020
OG003
DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG
Title
Measurements
OG0000
OG0011
OG0020
OG003
DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG
Title
Measurements
OG0001
OG0010
OG0021
OG003
Placebo-Controlled: Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG0003.1
OG0010
OG0026.5
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG0003.1
OG0010
OG0020
OG002
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG0003.1
OG0010
OG0020
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Abdomen
Title
Measurements
OG0000
OG0010
OG0021
Extremities
Title
Measurements
OG0000
OG0011
OG0021
General Appearance
Title
Measurements
OG0001
OG0011
OG0020
Genitourinary
Title
Measurements
OG0001
OG0010
OG0020
Head, Eyes, Ears, Nose, Throat
Title
Measurements
OG0003
OG0016
OG0022
Lymph Nodes
Title
Measurements
OG0000
OG0010
OG0020
Mouth
Title
Measurements
OG0003
OG0010
OG0020
Musculoskeletal
Title
Measurements
OG0001
OG0011
OG0020
Neck
Title
Measurements
OG0000
OG0010
OG0020
Neurological
Title
Measurements
OG0002
OG0010
OG0021
Psychiatric
Title
Measurements
OG0001
OG0010
OG0021
Respiratory
Title
Measurements
OG0000
OG0011
OG0021
Skin
Title
Measurements
OG0009
OG00114
OG0026
Other
Title
Measurements
OG0001
OG0011
OG0020
OG003
Active Treatment Period: Placebo Followed bDeucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.