Psoriasis
Conditions
Keywords
Scalp Psoriasis, BMS-986165, Deucravacitinib, Psoriasis, Psoriasis Special Sites
Brief summary
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator 2. Deemed by the Investigator to be a candidate for phototherapy or systemic therapy 3. Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1 4. ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1 5. Evidence of plaque psoriasis in a non-scalp area 6. Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion criteria
* Target Disease Exceptions: 1. Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | Baseline and Week 16 | ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Baseline and Week 16 | Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing no scalp itch and 10 representing worst scalp itch imaginable.. Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours. |
| Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 | Baseline and Week 16 | s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). |
| Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | From week 0 through week 16 | 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 that does not necessarily have a causal relation with this treatment. |
| Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | Baseline and Week 16 | PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms. |
| Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Week 0 through Week 16 | Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization. |
| Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | Week 0 through Week 16 | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal |
| Number of Participants With Abnormalities in Vital Signs | Week 0 through Week 16 | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. |
| Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) | From week 0 through week 16 | A 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. |
Countries
France, Germany, Poland, United Kingdom, United States
Participant flow
Pre-assignment details
154 randomized and treated
Participants by arm
| Arm | Count |
|---|---|
| Deucravacitinib Deucravacitinib 6 mg daily (QD) | 103 |
| Placebo Placebo matching Deucravacitinib daily (QD) | 51 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Treatment: Week 16 - Week 52 | Adverse Event | 4 | 0 |
| Active Treatment: Week 16 - Week 52 | Death | 1 | 0 |
| Active Treatment: Week 16 - Week 52 | Lack of Efficacy | 4 | 1 |
| Active Treatment: Week 16 - Week 52 | Lost to Follow-up | 1 | 2 |
| Active Treatment: Week 16 - Week 52 | Non-compliance with protocol | 0 | 1 |
| Active Treatment: Week 16 - Week 52 | Withdrawal by Subject | 4 | 2 |
| Placebo Controlled: Week 0 - 16 | Adverse Event | 4 | 2 |
| Placebo Controlled: Week 0 - 16 | Lack of Efficacy | 1 | 0 |
| Placebo Controlled: Week 0 - 16 | Lost to Follow-up | 1 | 0 |
| Placebo Controlled: Week 0 - 16 | Other reasons | 0 | 2 |
| Placebo Controlled: Week 0 - 16 | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Deucravacitinib | Placebo |
|---|---|---|---|
| Age, Continuous | 42.9 Years STANDARD_DEVIATION 14.84 | 42.8 Years STANDARD_DEVIATION 15.7 | 43.2 Years STANDARD_DEVIATION 13.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 95 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 140 Participants | 93 Participants | 47 Participants |
| Sex: Female, Male Female | 65 Participants | 45 Participants | 20 Participants |
| Sex: Female, Male Male | 89 Participants | 58 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 51 | 1 / 94 | 0 / 45 |
| other Total, other adverse events | 47 / 103 | 14 / 51 | 42 / 94 | 16 / 45 |
| serious Total, serious adverse events | 1 / 103 | 1 / 51 | 4 / 94 | 0 / 45 |
Outcome results
Primary
Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.
Time frame: Baseline and Week 16
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deucravacitinib | Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | Full Analysis Set | 48.5 Percentage of responders |
| Deucravacitinib | Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | Patient sub-population (s-PGA ≥ 3) | 50.0 Percentage of responders |
| Placebo | Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | Patient sub-population (s-PGA ≥ 3) | 12.8 Percentage of responders |
| Placebo | Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | Full Analysis Set | 13.7 Percentage of responders |
Comparison: Full Analysis Setp-value: <0.000195% CI: [2.5, 15.3]Cochran-Mantel-Haenszel
Comparison: Patient sub-population (s-PGA ≥ 3)p-value: <0.000195% CI: [2.7, 18.4]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16
Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing no scalp itch and 10 representing worst scalp itch imaginable.. Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours.
Time frame: Baseline and Week 16
Population: All randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set | -3.2 Score on a scale | Standard Deviation 2.95 |
| Deucravacitinib | Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Patient sub-population (s-PGA ≥ 3) | -3.3 Score on a scale | Standard Deviation 2.87 |
| Placebo | Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set | -0.7 Score on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Patient sub-population (s-PGA ≥ 3) | -0.9 Score on a scale | Standard Deviation 2.29 |
Comparison: Full Analysis Setp-value: <0.000195% CI: [-3.3, -1.6]analysis of covariance model
Comparison: Patient sub-population (s-PGA ≥ 3)p-value: <0.000195% CI: [-3.3, -1.5]analysis of covariance model
Secondary
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal
Time frame: Week 0 through Week 16
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 3 X ULN | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 5 X ULN | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | Total Bilirubin > 2 X ULN | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 3 X ULN and total bilirubin > 2 X ULN on the same day | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 3 X ULN and total bilirubin > 2 X ULN on the same day | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 3 X ULN | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | Total Bilirubin > 2 X ULN | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | ALT or AST > 5 X ULN | 0 Participants |
Secondary
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization.
Time frame: Week 0 through Week 16
Population: All treated participants with baseline and post-baseline laboratory assessments
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Neutrophils (x10^9/L) Grade 1 | 5 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Urate (umol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Urea Nitrogen (mmol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Basophils (10^9/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Eosinophils (10^9/L) Grade 1 | 4 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Eosinophils (10^9/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 1 | 5 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 3 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 1 | 8 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 2 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 1 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 1 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Neutrophils (x10^9/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Platelets (10^9/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 1 | 8 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 2 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Albumin (g/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alkaline Phosphatase (U/L) Grade 1 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alkaline Phosphatase (U/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Aspartate Aminotransferase (U/L) Grade 1 | 5 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Aspartate Aminotransferase (U/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 1 | 5 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Calcium (mmol/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Chloride (mmol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Cholesterol (mmol/L) Grade 1 | 5 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Cholesterol (mmol/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatine Kinase (U/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 1 | 3 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Direct Bilirubin (umol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Glucose (mmol/L) Grade 1 | 2 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Glucose (mmol/L) Grade 2-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lactate Dehydrogenase (U/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Magnesium (mmol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Phosphate (mmol/L) Grade 1-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 1 | 6 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 2 | 8 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 3 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 2 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 3-4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 1 | 27 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 2 | 2 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 3 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 4 | 0 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Calcium (mmol/L) Grade 1 | 1 Participants |
| Deucravacitinib | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 1 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 1 | 2 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Aspartate Aminotransferase (U/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Glucose (mmol/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 1 | 3 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 2 | 3 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Basophils (10^9/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Bilirubin (umol/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Eosinophils (10^9/L) Grade 1 | 2 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Eosinophils (10^9/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Calcium (mmol/L) Grade 1 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 1 | 4 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 4 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Calcium (mmol/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Hemoglobin (g/L) Grade 3 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Phosphate (mmol/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 1 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Chloride (mmol/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 2 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Sodium (mmol/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Leukocytes (10^9/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Cholesterol (mmol/L) Grade 1 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 1 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 1 | 2 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Cholesterol (mmol/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Blood Test (10^9/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 3 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 1 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 2 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 1 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Lymphocytes Plasma Test (10^9/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Neutrophils (x10^9/L) Grade 1 | 2 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Triglycerides (mmol/L) Grade 1 | 7 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Neutrophils (x10^9/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 2 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Platelets (10^9/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 3 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 1 | 8 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Creatinine (umol/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 2 | 1 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alanine Aminotransferase (U/L) Grade 3-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Urea Nitrogen (mmol/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Albumin (g/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Direct Bilirubin (umol/L) Grade 1-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alkaline Phosphatase (U/L) Grade 1 | 2 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Potassium (mmol/L) Grade 4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Alkaline Phosphatase (U/L) Grade 2-4 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Glucose (mmol/L) Grade 1 | 0 Participants |
| Placebo | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Aspartate Aminotransferase (U/L) Grade 1 | 5 Participants |
Secondary
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
A 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.
Time frame: From week 0 through week 16
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| Placebo | Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
Secondary
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
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 that does not necessarily have a causal relation with this treatment.
Time frame: From week 0 through week 16
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 73 Participants |
| Placebo | Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 26 Participants |
Secondary
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Time frame: Week 0 through Week 16
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM BASELINE < -15 | 1 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED | 0 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM BASELINE > 20 | 3 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM BASELINE > 10 | 8 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): NOT REPORTED | 0 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM BASELINE < -10 | 0 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM BASELINE < -20 | 0 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED | 0 Participants |
| Deucravacitinib | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM BASELINE > 30 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM BASELINE > 30 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM BASELINE < -15 | 3 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | HEART RATE (BEATS/MIN): NOT REPORTED | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM BASELINE > 20 | 4 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM BASELINE < -20 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | SYSTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM BASELINE > 10 | 3 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM BASELINE < -10 | 2 Participants |
Secondary
Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms.
Time frame: Baseline and Week 16
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deucravacitinib | Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | Full Analysis Set | 38.8 Percentage of responders |
| Deucravacitinib | Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | Patient sub-population (s-PGA ≥ 3) | 40.6 Percentage of responders |
| Placebo | Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | Full Analysis Set | 2.0 Percentage of responders |
| Placebo | Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | Patient sub-population (s-PGA ≥ 3) | 2.1 Percentage of responders |
Comparison: Full Analysis Setp-value: <0.000195% CI: [4.6, 352]Cochran-Mantel-Haenszel
Comparison: Patient sub-population (s-PGA ≥ 3)p-value: <0.000195% CI: [4.4, 317.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16
s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Time frame: Baseline and Week 16
Population: All randomized participants with a s-PGA ≥ 3 at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deucravacitinib | Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 | 51.0 Percentage of responders |
| Placebo | Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 | 4.3 Percentage of responders |
p-value: <0.000195% CI: [5.4, 105.6]Cochran-Mantel-Haenszel