Status:
COMPLETED
A Study of KHK4827 in Subjects With Palmoplantar Pustulosis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04061252
Start Date
August 10 2019
End Date
August 5 2022
Last Update
February 14 2023
Active Locations (2)
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1
Takagi Dermatology clinic
Obihiro, Hokkaido, Japan
2
Sapporo Dermatology clinic
Sapporo, Hokkaido, Japan