A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2022-08-05

Brief Summary

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

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Detailed Description

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Conditions

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Palmoplantar Pustulosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KHK4827 210mg Q2W SC

Group Type EXPERIMENTAL

KHK4827

Intervention Type DRUG

brodalumab 210mg Q2W, SC

Placebo Q2W SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Q2W, SC

Interventions

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KHK4827

brodalumab 210mg Q2W, SC

Intervention Type DRUG

Placebo

Q2W, SC

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No