Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Symptom Severity Reduction
研究概览
简要总结
This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.
详细描述
This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Biopsy confirmed CD diagnosis
- •Seropositive
- •Gluten free diet (12 months minimum)
- •Experienced at least one self reported moderate or greater severity symptom during the last 28 day period
- •Willing to take study treatment daily
- •Must sign informed consent
排除标准
- •Wheat allergy
- •History of peptic ulcer disease, esophagitis, IBS, IBD
- •Active colitis, dermatitis herpetiformis
- •Diagnosed with Type 1 Diabetes
- •Patients with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
- •Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
- •Known refractory celiac disease (RCD1 or RCD2)
- •Inability to give informed consent
研究组 & 干预措施
Latiglutenase
IMGX003
干预措施: Latiglutenase (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Symptom Severity Reduction
时间窗: 6 months
The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.
次要结局
- Health Related Quality of Life(6 months)