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A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Primary Purpose

Palmoplantar Pustulosis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

KHK4827

Placebo

About this trial

This is an interventional treatment trial for Palmoplantar Pustulosis focused on measuring Palmoplantar Pustulosis, brodalumab, KHK4827

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Takagi Dermatology clinic
Sapporo Dermatology clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK4827 210mg Q2W SC

Placebo Q2W SC

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16

The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16

The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16

Change from baseline in PPPASI total score at each assessment time point

Change from baseline in PPP-SI total score at each assessment time point

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.

Full Information

NCT ID

NCT04061252

First Posted

July 16, 2019

Last Updated

February 13, 2023

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04061252

Brief Title

A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 10, 2019 (Actual)

Primary Completion Date

August 11, 2021 (Actual)

Study Completion Date

August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Palmoplantar Pustulosis

Keywords

Palmoplantar Pustulosis, brodalumab, KHK4827

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KHK4827 210mg Q2W SC

Arm Type

Experimental

Arm Title

Placebo Q2W SC

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

KHK4827

Intervention Description

brodalumab 210mg Q2W, SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Q2W, SC

Primary Outcome Measure Information:

Title

Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16

Description

Time Frame

Baseline, Week 16

Title

The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16

Time Frame

Week 16

Title

The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16

Time Frame

Week 16

Title

The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16

Time Frame

Week 16

Title

Change from baseline in PPPASI total score at each assessment time point

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68

Title

Change from baseline in PPP-SI total score at each assessment time point

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68

Title

Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point

Description

Time Frame

Baseline, Week 8, 16, 24, 32, 44, 56, 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Takagi Dermatology clinic

City

Obihiro

State/Province

Hokkaido

Country

Japan

Facility Name

Sapporo Dermatology clinic

City

Sapporo

State/Province

Hokkaido

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

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