A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 342
- 主要终点
- Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
研究概览
简要总结
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
详细描述
This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.
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 biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
- •measurable serology at screening
- •CeD GSRS score of ≥ 2.0 prior to randomization
- •experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
- •willing to maintain current diet gluten-free diet throughout the duration of the study.
排除标准
- •refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
- •chronic active GI disease other than celiac disease
- •diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
- •hemoglobin value < 8.5 g/dL
研究组 & 干预措施
Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
干预措施: Larazotide Acetate (Drug)
Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
干预措施: Larazotide Acetate (Drug)
Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
干预措施: Larazotide Acetate (Drug)
Placebo
placebo capsules TID
干预措施: placebo (Drug)
结局指标
主要结局
Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
时间窗: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
次要结局
- Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease(Up to 12 weeks)
- Validate a CeD PRO diary instrument in subjects with celiac disease(The CeD PRO was administered daily throughout the study.)
- Compare various efficacy endpoints during 12 weeks of double-blind treatment(GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.)