NCT02378688已完成2 期
A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
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
- 78
- 试验地点
- 2
- 主要终点
- Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12)
研究概览
简要总结
The primary objectives of the study are:
- To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
- To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.
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
- Double (Participant, Investigator)
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
- •Diagnosis of CD (involving small intestine and/or colon), confirmed by both endoscopy and histopathology at least 3 months prior to Visit 1
- •Previous use of any type of corticosteroids or immunosuppressants for the treatment of CD
- •Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1
排除标准
- •Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease
- •Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study
- •GI surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study
研究组 & 干预措施
MT-1303
Experimental
干预措施: MT-1303 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12)
时间窗: 14 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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