NCT01917630Unknown2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 500
- 主要终点
- Efficacy: Intestinal mucosal morphometry
研究概览
简要总结
To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 80 years
- •Physician diagnosed celiac disease
- •Adherence to a gluten-free diet
- •Experiencing symptoms of celiac disease over a 1-month period
- •Willing to take study medication for 12 weeks
- •Willing to comply with all study procedures
- •Sign informed consent
排除标准
- •Active inflammatory bowel disease
- •Active dermatitis herpetiformis
- •Use of certain specific medications prior to entry
- •History of alcohol or illicit drug abuse in previous 6 months
- •Pregnant or lactating
- •Received any experimental drug within 30 days of enrollment
- •Uncontrolled chronic disease or condition
研究组 & 干预措施
ALV003
Experimental
干预措施: ALV003 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Efficacy: Intestinal mucosal morphometry
时间窗: 12 weeks
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
次要结局
- Efficacy: Intestinal intraepithelial lymphocyte density(12 weeks)
- Safety: safety and tolerability of ALV003(12 weeks)
研究者
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