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
- 171
- 试验地点
- 1
- 主要终点
- Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
研究概览
简要总结
This study was conducted to evaluate the efficacy of multiple doses 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 was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were 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
Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: 900 mg gluten (Dietary Supplement)
Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: placebo (Drug)
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: 900 mg gluten (Dietary Supplement)
Larazotide acetate 4 mg
larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: larazotide acetate (Drug)
Larazotide acetate 4 mg
larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: 900 mg gluten (Dietary Supplement)
Larazotide acetate 8 mg
larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: larazotide acetate (Drug)
Larazotide acetate 8 mg
larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
干预措施: 900 mg gluten (Dietary Supplement)
结局指标
主要结局
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
时间窗: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
次要结局
- Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals(Up to 6 weeks)
- To prospectively validate a composite, weighted index of celiac disease activity(GSRS was completed weekly throughout the study.)