KHK4827
Drugbrodalumab 210mg Q2W, SC
NCT Number: NCT04061252
Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Takagi Dermatology clinic, Obihiro, Hokkaido, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
brodalumab 210mg Q2W, SC
Q2W, SC
Time frame: Baseline, 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
(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: Week 16
Time frame: Week 16
Time frame: Week 16
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
Time frame: Baseline, Week 8, 16, 24, 32, 44, 56, 68
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.
Kyowa Kirin Co., Ltd.
Industry
A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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