Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
Takagi Dermatology clinic
Obihiro, Hokkaido, Japan
Sapporo Dermatology clinic
Sapporo, Hokkaido, Japan
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula. PPPASI=(E+P+D) Area\*0.2 (RP)+(E+P+D) Area\*0.2 (LP)+ (E+P+D) Area\*0.3 (RS)+(E+P+D) Area\*0.3 (LS).
Time frame: Baseline, Week 16
Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16
(PPP-SI) total score at Week 16. PPP-SI assesses the severity of palmoplantar pustulosis skin lesions and response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Time frame: Baseline, Week 16
The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16
Time frame: Week 16
The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16
Time frame: Week 16
The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16
Time frame: Week 16
Change from baseline in PPPASI total score at each assessment time point
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Change from baseline in PPP-SI total score at each assessment time point
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
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Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point
The DLQI is a skin disease-specific scale that assesses the impact of skin symptoms on QOL during the past 7 days and consists of 10 questions relating to "symptoms and feelings", "daily activities", "leisure", "work and employment", "personal relationship", and "treatment". The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease.
Time frame: Baseline, Week 8, 16, 24, 32, 44, 56, 68