Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Symptom Severity Reduction
研究概览
简要总结
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.
详细描述
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The PI, CRA and study biostatistician will be masked until database lock.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Latiglutenase
IMGX003
干预措施: Latiglutenase (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Symptom Severity Reduction
时间窗: 6 months
The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.
次要结局
未报告次要终点