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

Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2013年1月28日最近更新: 2023年10月17日

研究概览

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•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.

•- 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 IP on psoriasis.
•- Subject has any active 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 UVB therapy within 14 days of the first dose or 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-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-IL17 biologic therapy

发起方

Kyowa Hakko Kirin Co., Ltd.