NCT04183881已完成4 期
An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Incidence and types of adverse events and adverse reactions
研究概览
简要总结
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.
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 voluntarily signed the written informed consent form to participate in this study
- •Subject has completed the study 4827-005 (phase 3)
排除标准
- •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
研究组 & 干预措施
Brodalumab 210mg SC
Experimental
Brodalumab 210mg subcutaneous injection
干预措施: Brodalumab 210mg SC (Drug)
结局指标
主要结局
Incidence and types of adverse events and adverse reactions
时间窗: 28 weeks
Anti-KHK4827 antibody
时间窗: 28 weeks
次要结局
- Change in body surface area involvement (BSA) of lesion(28 weeks)
- Percent improvement in PASI(28 weeks)
- American College of Rheumatology (ACR) 20(28 weeks)
- sPGA of "0 (clear)"(28 weeks)
- 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)
- PASI 50, 75, 90, and 100(28 weeks)
- Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"(28 weeks)
- Clinical Global Impression (CGI)(28 weeks)
- Pustular symptom score(28 weeks)
- Serum KHK4827 concentration(28 weeks)
研究者
研究点 (1)
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