Alopecia Areata
Conditions
Keywords
Deucravacitinib, IM011134, BMS-986165
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.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Placebo was administered.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Week 25 to Week 52 | Participants were assessed for abnormalities in targeted physical parameters. |
| Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | First dose (Day 1) to Week 24 | Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes. |
| Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | Week 25 to Week 52 | Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes. |
| Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | First dose (Day 1) to Week 24 | Participants were assessed for abnormalities in targeted physical parameters. |
| Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period | Baseline (Day 1) and Week 24 | The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region \[24%\], top region \[40%\], left region \[18%\] and, right region \[18%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. |
| Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection. |
| Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection. |
| 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 | From first dose (Day 1) through Week 24 | Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. |
| 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 | From Week 25 to Week 52 | Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. |
| Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | First dose (Day 1) to Week 24 | A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements |
| Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | Week 25 to Week 52 | A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | Baseline (Day 1) and Week 24 | The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. percentage of participants achieving an absolute SALT score ≤ 20, indicates ≤ 20% scalp hair loss. |
| 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 | 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). |
| 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 | 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. |
Countries
Australia, Canada, France, Japan, Poland, United States
Participant flow
Recruitment details
Study was terminated due to change in business objectives.
Pre-assignment details
94 participants randomized and treated in Placebo controlled period. the 31 participants in the placebo cohort, were re-randomized into the active treatment cohort.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 31 |
| Placebo Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period. | 31 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Active Treatment (Week 25 to Week 52) | Adverse Event | 1 | 1 | 0 | 1 | 0 |
| Active Treatment (Week 25 to Week 52) | Lack of Efficacy | 1 | 1 | 0 | 1 | 0 |
| Active Treatment (Week 25 to Week 52) | Lost to Follow-up | 0 | 2 | 0 | 0 | 1 |
| Active Treatment (Week 25 to Week 52) | Participant request to discontinue study treatment | 1 | 3 | 0 | 0 | 1 |
| Active Treatment (Week 25 to Week 52) | Study terminated by sponsor | 19 | 12 | 0 | 6 | 9 |
| Active Treatment (Week 25 to Week 52) | Withdrawal by Subject | 2 | 2 | 0 | 3 | 1 |
| Placebo-Controlled (Day 1 to Week 24) | Adverse Event | 0 | 2 | 0 | 0 | 0 |
| Placebo-Controlled (Day 1 to Week 24) | Participant request to discontinue study treatment | 0 | 2 | 0 | 0 | 0 |
| Placebo-Controlled (Day 1 to Week 24) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Deucravacitinib 6 mg QD | Deucravacitinib 6 mg BID | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 13.37 | 43.4 years STANDARD_DEVIATION 13.81 | 38.9 years STANDARD_DEVIATION 14.4 | 39.4 years STANDARD_DEVIATION 14.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 28 Participants | 31 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 10 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 22 Participants | 20 Participants | 19 Participants | 61 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 20 Participants | 64 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 11 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 | 0 / 31 | 0 / 32 | 0 / 26 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 24 / 32 | 26 / 31 | 16 / 31 | 15 / 32 | 14 / 26 | 13 / 16 | 14 / 15 |
| serious Total, serious adverse events | 1 / 32 | 1 / 31 | 0 / 31 | 0 / 32 | 1 / 26 | 0 / 16 | 0 / 15 |
Outcome results
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.
Time frame: Baseline (Day 1) and Week 24
Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period | -5.809 Score on a Scale | Standard Deviation 13.3892 |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period | 1.027 Score on a Scale | Standard Deviation 14.7258 |
| Placebo | Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period | -7.302 Score on a Scale | Standard Deviation 17.8732 |
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.
Time frame: Week 25 to Week 52
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 1 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 1 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 3 Participants |
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.
Time frame: First dose (Day 1) to Week 24
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 4 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period | DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG | 1 Participants |
Primary
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Participants were assessed for abnormalities in targeted physical parameters.
Time frame: Week 25 to Week 52
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Respiratory | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Musculoskeletal | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Lymph Nodes | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Genitourinary | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Abdomen | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Head, Eyes, Ears, Nose, Throat | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Mouth | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Psychiatric | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Other | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Extremities | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Skin | 8 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neurological | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neck | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | General Appearance | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Other | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Mouth | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Abdomen | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Extremities | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | General Appearance | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Genitourinary | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Head, Eyes, Ears, Nose, Throat | 5 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Lymph Nodes | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Musculoskeletal | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neck | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neurological | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Psychiatric | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Respiratory | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Skin | 6 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Lymph Nodes | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Respiratory | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Musculoskeletal | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neck | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Extremities | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Mouth | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neurological | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Other | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Abdomen | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Psychiatric | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Genitourinary | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Head, Eyes, Ears, Nose, Throat | 2 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Skin | 5 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | General Appearance | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Head, Eyes, Ears, Nose, Throat | 2 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Other | 4 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Mouth | 2 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Musculoskeletal | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Extremities | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Respiratory | 2 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Skin | 8 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neck | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | General Appearance | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Psychiatric | 1 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Genitourinary | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Neurological | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Abdomen | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters | Lymph Nodes | 0 Participants |
Primary
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Participants were assessed for abnormalities in targeted physical parameters.
Time frame: First dose (Day 1) to Week 24
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Psychiatric | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Lymph Nodes | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | General Appearance | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neurological | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Mouth | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Extremities | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neck | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Musculoskeletal | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Respiratory | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Genitourinary | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Other | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Abdomen | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Head, Eyes, Ears, Nose, Throat | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Skin | 9 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Psychiatric | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Abdomen | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Extremities | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | General Appearance | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Genitourinary | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Head, Eyes, Ears, Nose, Throat | 6 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Lymph Nodes | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Mouth | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Musculoskeletal | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neck | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neurological | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Respiratory | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Skin | 14 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Other | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Skin | 6 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neurological | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Head, Eyes, Ears, Nose, Throat | 2 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Genitourinary | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Psychiatric | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | General Appearance | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Abdomen | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Respiratory | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Extremities | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Musculoskeletal | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Mouth | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Other | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Neck | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period | Lymph Nodes | 0 Participants |
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
Time frame: Week 25 to Week 52
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | PR INTERVAL >= 200 MSEC | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QRS INTERVAL >= 120 MSEC | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | PR INTERVAL >= 200 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QRS INTERVAL >= 120 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 1 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | PR INTERVAL >= 200 MSEC | 1 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QRS INTERVAL >= 120 MSEC | 1 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF >= 500 MSEC | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QRS INTERVAL >= 120 MSEC | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | PR INTERVAL >= 200 MSEC | 1 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 1 Participants |
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
Time frame: First dose (Day 1) to Week 24
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | PR INTERVAL >= 200 MSEC | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QRS INTERVAL >= 120 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QRS INTERVAL >= 120 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 2 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | PR INTERVAL >= 200 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 480 -< 500 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF >= 500 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QRS INTERVAL >= 120 MSEC | 1 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF CHANGE FROM BASELINE > 60 MSEC | 0 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | QTCF 450 -< 480 MILLISECONDS (MSEC) | 1 Participants |
| Placebo | Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period | PR INTERVAL >= 200 MSEC | 1 Participants |
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.
Time frame: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events | 21 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Serious Treatment Emergent Adverse Events | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Bowen's Disease | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Bowen's Disease | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Serious Treatment Emergent Adverse Events | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events | 17 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Bowen's Disease | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events | 13 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Serious Treatment Emergent Adverse Events | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Serious Treatment Emergent Adverse Events | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | Treatment Emergent Adverse Events | 14 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Bowen's Disease | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
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.
Time frame: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events | 25 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Serious Treatment Emergent Adverse Events | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Herpes Zoster | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Bowen's Disease) | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 3 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Bowen's Disease) | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events | 28 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Serious Treatment Emergent Adverse Events | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events Leading to Discontinuation of Study | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Serious Treatment Emergent Adverse Events | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | Treatment Emergent Adverse Events | 20 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Herpes Zoster | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Opportunistic Infections | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest-Malignancy-Bowen's Disease) | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period | TEAE of Interest - Tuberculosis Infection | 0 Participants |
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.
Time frame: From Week 25 to Week 52
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CREATINE KINASE (CK), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | SODIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | SODIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CALCIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CALCIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CREATINE KINASE (CK), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | SODIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | SODIUM, HIGH | 0 Participants |
| Placebo | 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 | CREATINE KINASE (CK), HIGH | 0 Participants |
| Placebo | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Placebo | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo | 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 | CALCIUM, LOW | 0 Participants |
| Placebo | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo | 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 | SODIUM, LOW | 0 Participants |
| Placebo | 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 | SODIUM, HIGH | 0 Participants |
| Placebo | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | CALCIUM, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | ALBUMIN, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | POTASSIUM, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | PLATELET COUNT, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | SODIUM, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | SODIUM, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | CREATINE KINASE (CK), HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | LEUKOCYTES, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | GLUCOSE, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | CALCIUM, HIGH | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID | 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 | POTASSIUM, LOW | 0 Participants |
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.
Time frame: From first dose (Day 1) through Week 24
Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CREATINE KINASE (CK), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CALCIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | SODIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | SODIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | SODIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CALCIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | CREATINE KINASE (CK), HIGH | 1 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | SODIUM, LOW | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Placebo | 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 | PLATELET COUNT, LOW | 0 Participants |
| Placebo | 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 | GLUCOSE, LOW | 0 Participants |
| Placebo | 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 | BILIRUBIN, TOTAL, HIGH | 0 Participants |
| Placebo | 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 | GLUCOSE FASTING, LOW | 0 Participants |
| Placebo | 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 | POTASSIUM, LOW | 0 Participants |
| Placebo | 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 | ASPARTATE AMINOTRANSFERASE (AST), HIGH | 0 Participants |
| Placebo | 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 | TRIGLYCERIDES, HIGH | 0 Participants |
| Placebo | 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 | POTASSIUM, HIGH | 0 Participants |
| Placebo | 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 | ALKALINE PHOSPHATASE (ALP), HIGH | 0 Participants |
| Placebo | 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 | HEMOGLOBIN, LOW | 0 Participants |
| Placebo | 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 | SODIUM, LOW | 0 Participants |
| Placebo | 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 | ALANINE AMINOTRANSFERASE (ALT), HIGH | 0 Participants |
| Placebo | 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 | CALCIUM, HIGH | 0 Participants |
| Placebo | 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 | CALCIUM, LOW | 0 Participants |
| Placebo | 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 | LEUKOCYTES, LOW | 0 Participants |
| Placebo | 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 | CHOLESTEROL, TOTAL (TC), HIGH | 0 Participants |
| Placebo | 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 | ALBUMIN, LOW | 0 Participants |
| Placebo | 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 | SODIUM, HIGH | 0 Participants |
| Placebo | 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 | CREATINE KINASE (CK), HIGH | 2 Participants |
| Placebo | 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 | CREATININE, ENZYMATIC, HIGH | 0 Participants |
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.
Time frame: Baseline (Day 1) and Week 24
Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24 | 3.1 Percentage of participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24 | 6.5 Percentage of participants |
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).
Time frame: Baseline (Day 1) and week 24
Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | 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 | 3.1 Percentage of participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | 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 | 0 Percentage of participants |
| Placebo | 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 | 0 Percentage of participants |
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.
Time frame: Baseline (Day 1) and Week 24
Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled: Deucravacitinib 6 mg QD | Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | 3.1 Percentage of participants |
| Placebo-Controlled: Deucravacitinib 6 mg BID | Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | 0 Percentage of participants |