A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Moderate to Severe Plaque Psoriasis

Treatments

Drug: KHK4827

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02982005

4827-KR001

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks

Enrollment

62 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has had stable moderate to severe plaque psoriasis for at least 6 months
Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion criteria

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
Subject scheduled to undergo a surgical intervention during the study period
Subject has any active infection or history of infections as defined in the study protocol
Subject has known history of Crohn's disease
Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
Subject has not stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used any anti-IL-17 biologic therapy
Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Subject has known history of alcohol and/or substance abuse within the last 12 months"