The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
Specified dose on specified days
Specified dose on specified days
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Time frame: Week 16
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Time frame: Week 16
Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
The Palmoplantar Physician's Global Assessment (pp-PGA) is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The pp-PGA 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Time frame: Week 16
Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16
The Genital Psoriasis Symptoms Scale (GPSS) is a participant-administered questionnaire that contains 8 items regarding GenPs symptoms and has a recall period of 24 hours. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents "no symptom" and 10 represents "worst symptom imaginable". A total score ranging from 0 (no GenPs symptoms) to 80 (worst imaginable GenPs symptoms)
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Local Institution - 0050
Phoenix, Arizona, United States
Local Institution - 0015
Fountain Valley, California, United States
Local Institution - 0009
Los Angeles, California, United States
Local Institution - 0004
Santa Monica, California, United States
Local Institution - 0057
Skokie, Illinois, United States
Local Institution - 0052
Indianapolis, Indiana, United States
Local Institution - 0053
Plainfield, Indiana, United States
Local Institution - 0029
Rockville, Maryland, United States
Local Institution - 0012
Detroit, Michigan, United States
Local Institution - 0005
East Windsor, New Jersey, United States
...and 21 more locations
Time frame: Week 16
Number of Participants With Adverse Events
Adverse Events (AEs) are any new or worsening medical occurrences in participants receiving study treatment, regardless of whether they are related to the treatment. AEs include any unfavorable and unintended sign, symptom, or disease temporally associated with treatment. Serious Adverse Events (SAEs) are defined as events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability, are congenital anomalies/birth defects, or are otherwise medically significant.
Time frame: Week 0 through Week 16
Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results
Blood samples were collected to assess the laboratory parameters. Laboratory toxicities are graded using NCI CTCAE v3.0. Grade 3 and 4 represent severe and life-threatening abnormalities, respectively.
Time frame: Week 0 through Week 16
Number of Participants With Vital Sign Summaries Per Categories
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Heart rate was measured in beats/min and DBP and SBP was measured in mmHG.
Time frame: Week 0 through Week 16