Trial Outcomes & Findings for Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis (NCT NCT05478499)
NCT ID: NCT05478499
Last Updated: 2025-10-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2025-10-28
Participant Flow
154 randomized and treated
Participant milestones
| Measure |
Deucravacitinib
Deucravacitinib 6 mg daily (QD)
|
Placebo
Placebo matching Deucravacitinib daily (QD)
|
|---|---|---|
|
Placebo Controlled: Week 0 - 16
STARTED
|
103
|
51
|
|
Placebo Controlled: Week 0 - 16
COMPLETED
|
94
|
45
|
|
Placebo Controlled: Week 0 - 16
NOT COMPLETED
|
9
|
6
|
|
Active Treatment: Week 16 - Week 52
STARTED
|
94
|
45
|
|
Active Treatment: Week 16 - Week 52
COMPLETED
|
80
|
39
|
|
Active Treatment: Week 16 - Week 52
NOT COMPLETED
|
14
|
6
|
Reasons for withdrawal
| Measure |
Deucravacitinib
Deucravacitinib 6 mg daily (QD)
|
Placebo
Placebo matching Deucravacitinib daily (QD)
|
|---|---|---|
|
Placebo Controlled: Week 0 - 16
Adverse Event
|
4
|
2
|
|
Placebo Controlled: Week 0 - 16
Withdrawal by Subject
|
3
|
2
|
|
Active Treatment: Week 16 - Week 52
Withdrawal by Subject
|
4
|
2
|
|
Active Treatment: Week 16 - Week 52
Death
|
1
|
0
|
|
Active Treatment: Week 16 - Week 52
Non-compliance with protocol
|
0
|
1
|
|
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
|
|
Active Treatment: Week 16 - Week 52
Lack of Efficacy
|
4
|
1
|
|
Active Treatment: Week 16 - Week 52
Adverse Event
|
4
|
0
|
|
Active Treatment: Week 16 - Week 52
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Baseline characteristics by cohort
| Measure |
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 15.70 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
42.9 Years
STANDARD_DEVIATION 14.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: All randomized participants
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
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
Interval 5.7 to 26.3
|
48.5 Percentage of responders
Interval 38.6 to 58.6
|
|
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
Interval 4.8 to 25.7
|
50.0 Percentage of responders
Interval 39.6 to 60.4
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: All randomized participants
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
Full Analysis Set
|
2.0 Percentage of responders
Interval to 10.4
Insufficient number of participants with events. Lower limit value is "\< 0.1"
|
38.8 Percentage of responders
Interval 29.4 to 48.9
|
|
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
Interval to 11.3
Insufficient number of participants with events. Lower limit value is "\< 0.1"
|
40.6 Percentage of responders
Interval 30.7 to 51.1
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: All randomized participants
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
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
|
-3.2 Score on a scale
Standard Deviation 2.95
|
|
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
|
-3.3 Score on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: All randomized participants with a s-PGA ≥ 3 at baseline
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).
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=96 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
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
Interval 0.5 to 14.5
|
51.0 Percentage of responders
Interval 40.6 to 61.4
|
SECONDARY outcome
Timeframe: From week 0 through week 16Population: All treated participants
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
|
26 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From week 0 through week 16Population: All treated participants
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: All treated participants with baseline and post-baseline laboratory assessments
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Albumin (g/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Cholesterol (mmol/L) Grade 1
|
0 Participants
|
5 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Creatine Kinase (U/L) Grade 1-4
|
—
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Potassium (mmol/L) Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Sodium (mmol/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Triglycerides (mmol/L) Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Hemoglobin (g/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Hemoglobin (g/L) Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Leukocytes (10^9/L) Grade 1
|
1 Participants
|
8 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Leukocytes (10^9/L) Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Leukocytes (10^9/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Blood Test (10^9/L) Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Blood Test (10^9/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Blood Test (10^9/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Plasma Test (10^9/L) Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Plasma Test (10^9/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lymphocytes Plasma Test (10^9/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Neutrophils (x10^9/L) Grade 1
|
2 Participants
|
5 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Neutrophils (x10^9/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Platelets (10^9/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Alanine Aminotransferase (U/L) Grade 1
|
8 Participants
|
8 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Alanine Aminotransferase (U/L) Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Alanine Aminotransferase (U/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Cholesterol (mmol/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Creatinine (umol/L) Grade 1
|
0 Participants
|
3 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Creatinine (umol/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Creatinine (umol/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Direct Bilirubin (umol/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Glucose (mmol/L) Grade 1
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Glucose (mmol/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Magnesium (mmol/L) Grade 1-4
|
—
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Phosphate (mmol/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Bilirubin (umol/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Bilirubin (umol/L) Grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Calcium (mmol/L) Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Potassium (mmol/L) Grade 1
|
2 Participants
|
6 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Potassium (mmol/L) Grade 2
|
1 Participants
|
8 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Calcium (mmol/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Chloride (mmol/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Lactate Dehydrogenase (U/L) Grade 1-4
|
—
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Alkaline Phosphatase (U/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Aspartate Aminotransferase (U/L) Grade 1
|
5 Participants
|
5 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Aspartate Aminotransferase (U/L) Grade 2-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Bilirubin (umol/L) Grade 1
|
3 Participants
|
5 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Sodium (mmol/L) Grade 1
|
2 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Sodium (mmol/L) Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Triglycerides (mmol/L) Grade 1
|
7 Participants
|
27 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Triglycerides (mmol/L) Grade 2
|
3 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Triglycerides (mmol/L) Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Urate (umol/L) Grade 1-4
|
—
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Alkaline Phosphatase (U/L) Grade 1
|
2 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Potassium (mmol/L) Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Urea Nitrogen (mmol/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Hemoglobin (g/L) Grade 1
|
4 Participants
|
5 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Basophils (10^9/L) Grade 1-4
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Eosinophils (10^9/L) Grade 1
|
2 Participants
|
4 Participants
|
|
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
Eosinophils (10^9/L) Grade 2-4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: All treated participants
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
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
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
ALT or AST > 3 X ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
ALT or AST > 5 X ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
Total Bilirubin > 2 X ULN
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: All treated participants
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo matching Deucravacitinib daily (QD)
|
Deucravacitinib
n=103 Participants
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs
HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM BASELINE > 30
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM BASELINE < -15
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
HEART RATE (BEATS/MIN): NOT REPORTED
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM BASELINE > 20
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM BASELINE < -20
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM BASELINE > 10
|
3 Participants
|
8 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM BASELINE < -10
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo Controlled - Deucravacitinib
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo Controlled - Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Active Treatment - Deucravacitinib - Deucravacitinib
Serious events: 4 serious events
Other events: 42 other events
Deaths: 1 deaths
Active Treatment - Placebo - Deucravacitinib
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Controlled - Deucravacitinib
n=103 participants at risk
Deucravacitinib 6 mg daily (QD)
|
Placebo Controlled - Placebo
n=51 participants at risk
Placebo matching Deucravacitinib daily (QD)
|
Active Treatment - Deucravacitinib - Deucravacitinib
n=94 participants at risk
Deucravacitinib 6 mg daily (QD)
|
Active Treatment - Placebo - Deucravacitinib
n=45 participants at risk
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
2.0%
1/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
1.1%
1/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.97%
1/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
1.1%
1/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
1.1%
1/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
1.1%
1/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
Other adverse events
| Measure |
Placebo Controlled - Deucravacitinib
n=103 participants at risk
Deucravacitinib 6 mg daily (QD)
|
Placebo Controlled - Placebo
n=51 participants at risk
Placebo matching Deucravacitinib daily (QD)
|
Active Treatment - Deucravacitinib - Deucravacitinib
n=94 participants at risk
Deucravacitinib 6 mg daily (QD)
|
Active Treatment - Placebo - Deucravacitinib
n=45 participants at risk
Deucravacitinib 6 mg daily (QD)
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
12/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
3.9%
2/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
11.7%
11/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
6.7%
3/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Infections and infestations
Acne pustular
|
5.8%
6/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
3.2%
3/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Infections and infestations
COVID-19
|
5.8%
6/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
7.8%
4/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
12.8%
12/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
8.9%
4/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Infections and infestations
Nasopharyngitis
|
15.5%
16/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
13.7%
7/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
23.4%
22/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
17.8%
8/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Nervous system disorders
Headache
|
7.8%
8/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
3.9%
2/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
2.1%
2/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
2.2%
1/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.7%
10/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
1.1%
1/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
2.2%
1/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
2/103 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
5.9%
3/51 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
4.3%
4/94 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
0.00%
0/45 • Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER