Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

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.

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.

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.

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).

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.

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.

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 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 including heart rate, systolic blood pressure, and diastolic blood pressure.