A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Response to gluten
研究概览
简要总结
This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease
详细描述
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.
Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
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)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
- •Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
- •BMI between 18.5 and 38, inclusive.
- •Exclusion Criteria
- •Has chronic active GI disease other than celiac disease
- •Has diabetes (Type 1 or Type 2).
- •Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
- •Has hemoglobin value below 8.5 g/dL
排除标准
- 未提供
研究组 & 干预措施
Larazotide acetate 1 mg
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: Larazotide acetate (Drug)
Larazotide acetate 1 mg
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: Gluten 900 mg (Dietary Supplement)
Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: Placebo (Drug)
Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: Gluten 900 mg (Dietary Supplement)
结局指标
主要结局
Response to gluten
时间窗: 6 weeks
次要结局
- Anti-transglutaminase(6 weeks)