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

• Status: Completed
• Trial end date: 2018-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Korea Co., Ltd.; Kyowa Kirin Korea Co., Ltd.
• Treatments: Brodalumab

Criteria

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"