NCT03870334终止2 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
NImmune Biopharma1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年5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
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Clinical Remission Rate
研究概览
简要总结
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
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
- Triple (Participant, 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
- •Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
- •Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);
- •Key exclusion criteria:
- •Ulcerative colitis;
- •Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
排除标准
- 未提供
研究组 & 干预措施
BT-11 880 mg
Experimental
Oral once daily tablet
干预措施: BT-11 880 mg (Drug)
Placebo
Placebo Comparator
Oral once daily tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Remission Rate
时间窗: 12 weeks
Clinical remission defined by CDAI score \<150.
次要结局
未报告次要终点
研究者
研究点 (1)
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