Clinical trial NCT04061252: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Palmoplantar Pustulosis
Keywords: Palmoplantar Pustulosis
brodalumab
KHK4827
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis


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

Primary outcomes:
measure: Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16
timeFrame: Baseline, Week 16
measure: The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16
timeFrame: Week 16
measure: The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16
timeFrame: Week 16
measure: The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Change from baseline in PPPASI total score at each assessment time point
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
measure: Change from baseline in PPP-SI total score at each assessment time point
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point
timeFrame: Baseline, Week 8, 16, 24, 32, 44, 56, 68
Other outcomes:
Locations:
city: Obihiro
country: Japan
facility: Takagi Dermatology clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Dermatology clinic
state: Hokkaido
Study officials:
References: