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

NCT ID: NCT02982005

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-08-14

Brief 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

Conditions

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

KHK4827

KHK4827 administered SC

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

Administered KHK4827 by subcutaneous (SC) injection until week 62.

Placebo

Placebo administered SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.

Interventions

KHK4827

Administered KHK4827 by subcutaneous (SC) injection until week 62.

Intervention Type: DRUG

Placebo

Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.

Intervention Type: DRUG

Other Intervention Names

Brodalumab

Eligibility 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"

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Korea Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea, Republic of

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4827-KR001

Identifier Type: -

Identifier Source: org_study_id