A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Palmoplantar Pustulosis

Treatments

Drug: Placebo

Drug: KHK4827

Study type

Interventional

Funder types

Industry

Identifiers

4827-009

Details and patient eligibility

About

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis

Enrollment

126 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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