A Phase 4 Clinical Study of Brodalumab

Study Overview
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Brief Summary
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This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.

Official Title
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An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Conditions
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Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma

Intervention / Treatment
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* Drug: Brodalumab 210mg SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has voluntarily signed the written informed consent form to participate in this study Subject has completed the study 4827-005 (phase 3) Exclusion Criteria: Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brodalumab 210mg SC<br>Brodalumab 210mg subcutaneous injection | Drug: Brodalumab 210mg SC<br>* 210 mg, subcutaneous dosing, every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of adverse events and adverse reactions |  | 28 weeks | 
| Anti-KHK4827 antibody |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. |  | 28 weeks | 
| Percent improvement in PASI |  | 28 weeks | 
| PASI 50, 75, 90, and 100 |  | 28 weeks | 
| Static physician's global assessment (sPGA) of 0 (clear) or 1(almost clear) |  | 28 weeks | 
| sPGA of 0 (clear) |  | 28 weeks | 
| Change in body surface area involvement (BSA) of lesion |  | 28 weeks | 
| Clinical Global Impression (CGI) |  | 28 weeks | 
| American College of Rheumatology (ACR) 20 |  | 28 weeks | 
| Pustular symptom score | This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels). | 28 weeks | 
| Serum KHK4827 concentration |  | 28 weeks |