A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04061252
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kyowa Kirin Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Palmoplantar Pustulosis
Arms & Interventions

Arms

Experimental: KHK4827 210mg Q2W SC

Placebo Comparator: Placebo Q2W SC

Interventions

Drug: - KHK4827

brodalumab 210mg Q2W, SC

Drug: - Placebo

Q2W, SC

Contact a Trial Team

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International Sites

Takagi Dermatology clinic, Obihiro, Hokkaido, Japan

Status

Recruiting

Address

Takagi Dermatology clinic

Obihiro, Hokkaido,

Sapporo Dermatology clinic, Sapporo, Hokkaido, Japan

Status

Recruiting

Address

Sapporo Dermatology clinic

Sapporo, Hokkaido,

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