NCT01882504已完成2 期
An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of 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
- 8
- 主要终点
- Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
研究概览
简要总结
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
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
- •An established diagnosis of pyoderma gangrenosum
- •Currently experiencing an inflammatory episode of pyoderma gangrenosum
- •Contraceptive measures adequate to prevent pregnancy during the study
排除标准
- •Clinical evidence of acutely infected pyoderma gangrenosum
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •History of recurrent or chronic systemic infections
- •Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
gevokizumab
Experimental
Solution for subcutaneous injection
干预措施: gevokizumab (Drug)
结局指标
主要结局
Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
时间窗: Day 1 through Day 84
次要结局
未报告次要终点
研究者
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