NCT01965613已完成2 期
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Physician's Wound Assessment & Patient's Global Assessment
研究概览
简要总结
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.
详细描述
XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.
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
- •History of pyoderma gangrenosum with or without other systemic disease.
排除标准
- •Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- •Treatment with corticosteroids or cyclosporine within the last 2 weeks.
研究组 & 干预措施
open label-Xilonix
Experimental
Open label-Xilonix
干预措施: Xilonix (Biological)
结局指标
主要结局
Change in Physician's Wound Assessment & Patient's Global Assessment
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
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