An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

Study Overview
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Brief Summary
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This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

Official Title
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A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: KHK4827


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed voluntarily the written informed consent form to participate in this study. Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma. Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator. Exclusion Criteria: Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline. Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis. Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis. Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose. Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively. Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy Subject has used live vaccine within 3 months of the first dose Subject has previously used an anti-IL-17 biologic therapy

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: KHK4827<br> | Drug: KHK4827<br>* 140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) | CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) |  | 52 weeks | 
| American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) |  | 52 weeks | 
| Pustular symptom score (only in subjects with pustular psoriasis) |  | 52 weeks | 
| Static physician's global assessment (sPGA) of clear or almost clear (0 or 1) at Week 12 (only in subjects with psoriatic erythroderma) |  | 52 weeks | 
| sPGA of clear (0) at Week 12 (only in subjects with psoriatic erythroderma) |  | 52 weeks | 
| Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) |  | 52 weeks | 
| Incidence and types of adverse events and adverse reactions |  | 52 weeks | 
| Laboratory values and vital signs |  | 52 weeks | 
| Profiles of pharmacokinetics | Concentration of KHK4827 in serum | 52 weeks | 
| Development of anti-KHK4827 antibody |  | 52 weeks |