A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.
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
- •Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
- •On a gluten-free diet for at least 12 months
- •Negative celiac serology
- •Avoidance of pregnancy
排除标准
- •Severe complications of celiac disease, such as refractory celiac disease
- •Celiac symptoms
- •Other concomitant autoimmune disease
- •Chronic, active gastrointestinal disease
- •Infections, concomitant diseases
- •Prohibited medications
结局指标
主要结局
Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
时间窗: Baseline and week 12
Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
次要结局
- Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12(Baseline and week 12)
- Number of Participants With Improvement in Marsh Score at Week 12(Baseline and week 12)
- Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12(Baseline and week 12)
- Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12(Baseline and week 12)
- Number of Weekly Bowel Movements at Baseline and Week 12(Baseline and week 12)
- Number of Participants With Diarrhoea at Baseline and Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12(Baseline and 12 weeks)
- Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12(Baseline and 12 weeks)