A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
研究概览
简要总结
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.
详细描述
This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
- •Marsh score ≥ II at screening
- •Positive serum anti-tTG antibodies as determined by screening serology
- •Willing to comply with a gluten-free diet for the duration of the study
排除标准
- •Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
- •Has chronic active GI disease other than Celiac Disease
- •Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
- •Has hemoglobin value below 8.5 g/dL
研究组 & 干预措施
Larazotide acetate 4 mg
larazotide acetate capsules 4 mg TID
干预措施: larazotide acetate (Drug)
Larazotide acetate 8 mg
Larazotide acetate capsules 8 mg TID
干预措施: larazotide acetate (Drug)
Placebo
Placebo capsules
干预措施: placebo (Drug)
结局指标
主要结局
Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
时间窗: duodeno-jejunal biopsies were performed at Baseline and Day 56
Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.
次要结局
- To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.(Up to 8 weeks)
- To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.(CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.)
- Assess the safety and tolerability of larazotide acetate(Up to 8 weeks)
- To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects(Blood draws occurred at Visits 1, 2, 3, 4 and 5.)