NCT01782937已完成3 期
A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Global Impression (CGI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
KHK4827
Experimental
干预措施: KHK4827 (Drug)
结局指标
主要结局
Clinical Global Impression (CGI)
时间窗: 52 weeks
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
次要结局
- Laboratory values and vital signs(52 weeks)
- Profiles of pharmacokinetics(52 weeks)
- Development of anti-KHK4827 antibody(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)
- 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)
- 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)
- sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)(52 weeks)
研究者
研究点 (1)
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