NCT04741087已完成2 期
A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis
Applied Molecular Transport34 个研究点 分布在 10 个国家目标入组 22 人开始时间: 2021年2月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 34
- 主要终点
- Stool Frequency Response
研究概览
简要总结
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
详细描述
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic or recurrent pouchitis
排除标准
- •Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- •History or current evidence of colonic or abdominal abnormalities.
- •Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
研究组 & 干预措施
AMT-101 (Dose A)
Active Comparator
Dose A: AMT-101 Tablet
干预措施: AMT-101 (oral)-Dose A (Drug)
AMT-101 (Dose B)
Active Comparator
Dose B: AMT-101 Tablet
干预措施: AMT-101 (oral)-Dose B (Drug)
结局指标
主要结局
Stool Frequency Response
时间窗: 12 weeks
Histologic Healing
时间窗: 12 weeks
based upon the Geboes scoring system and PDAI
次要结局
- Histologic Response(12 weeks)
- Change in Stool Frequency(12 weeks)
- Change in Endoscopic Score(12 weeks)
研究者
研究点 (34)
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