A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 100
- 试验地点
- 26
- 主要终点
- The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8.
研究概览
简要总结
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
详细描述
The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.
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, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
placebo solution injected subcutaneously daily into either thigh or abdomen.
干预措施: placebo (Drug)
teduglutide 0.05
teduglutide 0.05 mg/kg/d injected subcutaneously daily.
干预措施: Teduglutide 0.05 dose (Drug)
teduglutide 0.1
0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
干预措施: teduglutide 0.1 mg dose (Drug)
teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
干预措施: ALX-0600 (Drug)
teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
干预措施: teduglutide 0.05 (Drug)
teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
干预措施: teduglutide 0.2 mg (Drug)
结局指标
主要结局
The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8.
时间窗: 8 weeks of treatment
次要结局
- The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.(8 weeks of treatment)