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

Study Overview
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Brief Summary
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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

Official Title
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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: KHK4827
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827<br>KHK4827 administered SC | Drug: KHK4827<br>* Administered KHK4827 by subcutaneous (SC) injection until week 62.<br>* Other names: Brodalumab;|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis area and severity index (PASI) 75 response |  | at week 12 | 
| Static physician's global assessment (sPGA) of 0 (clear) or 1 (almost clear) |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI 50/75/90/100 response by visit |  | Baseline to week 64 | 
| sPGA of 0 (clear) or 1 (almost clear) by visit |  | Baseline to week 64 | 
| Body surface area (BSA) involvement of lesion |  | Baseline to week 64 | 
| Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline) |  | Baseline to week 64 | 
| Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline) |  | Baseline to week 64 | 
| Dermatology life quality index (DLQI) |  | Baseline to week 64 | 
| Treatment-emergent adverse events (TEAEs) or drug-related TEAEs |  | Baseline to week 64 | 
| Laboratory values |  | Baseline to week 64 | 
| Vital signs |  | Baseline to week 64 | 
| Anti-KHK4827 antibodies |  | Baseline, Week 12, Week 24, Week 48, Week 64 | 
| Serum KHK4827 concentration |  | Baseline, Week 8, Week 10, Week 12, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KHK4827 (brodalumab)