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Completed

NCT Number: NCT04061252

A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Takagi Dermatology clinic, Obihiro, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK4827

Drug

brodalumab 210mg Q2W, SC

Placebo

Drug

Q2W, SC

Primary outcomes

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

    Time frame: Baseline, 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 outcomes

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

    Time frame: Baseline, 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.

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

    Time frame: Week 16

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

    Time frame: Week 16

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

    Time frame: Week 16

  5. 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

  6. 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

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

    Time frame: Baseline, Week 8, 16, 24, 32, 44, 56, 68

    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.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2019
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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