A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With ALV003 In Patients With Well-Controlled Celiac Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Efficacy: Intestinal mucosal morphology
研究概览
简要总结
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
详细描述
Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of biopsy-proven celiac disease
- •Adherence to a gluten-free diet
- •TG2 antibody negative
- •Signed informed consent
排除标准
- •Active dermatitis herpetiformis
- •History of IgE-mediated reactions to gluten
- •Use of specific medications 6 months prior to entry
- •History of alcohol abuse or illicit drug use
- •Current untreated or GI disease
- •Positive pregnancy test
- •Received any experimental drug within 14 days of randomization
- •Uncontrolled chronic disease or condition
- •Uncontrolled complications of celiac disease
- •Any medical condition, which could adversely affect participation
结局指标
主要结局
Efficacy: Intestinal mucosal morphology
时间窗: 6 weeks
Safety: Tolerability of ALV003
时间窗: 6 weeks
次要结局
- Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype(6 weeks)
- Efficacy: Change in serological markers of celiac disease(6 weeks)