A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

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

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

Study Overview

• Status: Completed
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Drug: KHK4827; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Obihiro, Hokkaido, Japan
      • Takagi Dermatology Clinic
    • Sapporo, Hokkaido, Japan
      • Sapporo Dermatology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: KHK4827 210mg Q2W SC	Drug: KHK4827; brodalumab 210mg Q2W, SC
PLACEBO_COMPARATOR: Placebo Q2W SC	Drug: Placebo; Q2W, SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 16
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 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
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	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.	Baseline, Week 8, 16, 24, 32, 44, 56, 68

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2019
• Primary Completion (ACTUAL): August 11, 2021
• Study Completion (ACTUAL): August 5, 2022

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: brodalumab; Palmoplantar Pustulosis; KHK4827
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No