A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Palmoplantar Pustulosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061252
• Other study ID #: 4827-009
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2019
• Est. completion date: August 5, 2022

Study information

• Verified date: April 2022
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 5, 2022
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Drug:
• KHK4827
brodalumab 210mg Q2W, SC
• Placebo
Q2W, SC

Locations

Country	Name	City	State
Japan	Takagi Dermatology clinic	Obihiro	Hokkaido
Japan	Sapporo Dermatology clinic	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16		Week 16
Secondary	The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16		Week 16
Secondary	The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16		Week 16
Secondary	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
Secondary	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
Secondary	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