A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Study Overview
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Brief Summary
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Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis

Official Title
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A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis

Conditions
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Palmoplantar Pustulosis

Intervention / Treatment
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* Drug: KHK4827
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent. Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination; Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate Exclusion Criteria: Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx; Subject has an improvement in PPPASI total score of ≥4 points during the screening period; Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion; Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827 210mg Q2W SC<br> | Drug: KHK4827<br>* brodalumab 210mg Q2W, SC<br>|
| Placebo Comparator: Placebo Q2W SC<br> | Drug: Placebo<br>* Q2W, SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 16 | 
| The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16 |  | Week 16 | 
| The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16 |  | Week 16 | 
| The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16 |  | Week 16 | 
| Change from baseline in PPPASI total score at each assessment time point |  | 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 |  | Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 | 
| 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. | Baseline, Week 8, 16, 24, 32, 44, 56, 68 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palmoplantar Pustulosis, brodalumab, KHK4827