NCT02389790已完成2 期
A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study
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
- 46
- 试验地点
- 1
- 主要终点
- Number of Subjects with Adverse Events
研究概览
简要总结
The primary objectives of the study are:
-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.
排除标准
- •Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13
研究组 & 干预措施
MT-1303
Experimental
干预措施: MT-1303 (Drug)
结局指标
主要结局
Number of Subjects with Adverse Events
时间窗: 36 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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