NCT02326740终止3 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
研究概览
简要总结
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A clinical diagnosis of classic pyoderma gangrenosum
- •An active pyoderma gangrenosum ulcer
- •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 (Part 1, Group B)
干预措施: gevokizumab (Drug)
Placebo
Placebo Comparator
Solution for subcutaneous injection (Part 1, Group A)
干预措施: Placebo (Drug)
gevokizumab open-label
Experimental
Solution for subcutaneous injection (Part 2, Open-label)
干预措施: gevokizumab open-label (Drug)
结局指标
主要结局
The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
时间窗: Day 126
次要结局
- The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.(Day 126)
研究者
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