NCT02318914终止3 期
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With 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
- 15
- 主要终点
- Evaluation of treatment-emergent adverse events;
研究概览
简要总结
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
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
- •Individuals who participated in a previous study of gevokizumab in PG
- •A clinical diagnosis of classic 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
Evaluation of treatment-emergent adverse events;
时间窗: Up to 2 years
Changes from baseline vital signs, physical examination results, and laboratory test results
时间窗: Up to 2 years
Changes from baseline concomitant medications use
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
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