Palmoplantar Pustulosis
Conditions
Keywords
Palmoplantar Pustulosis, brodalumab, KHK4827
Brief summary
Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
Interventions
DRUGKHK4827
brodalumab 210mg Q2W, SC
DRUGPlacebo
Q2W, SC
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16 | 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. |
| 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 | 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. |
| 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 | — |
Countries
Japan
Outcome results
None listed