A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
研究概览
简要总结
Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of refractory celiac disease Type II (RCD-II)
- •Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow cytometry
- •On a gluten-free diet for at least 6 months
- •Avoid pregnancy
排除标准
- •Enteropathy-Associated T cell Lymphoma (EATL)
- •Infections
- •Immune suppression
- •Clinically significant co-morbidities
结局指标
主要结局
Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes
时间窗: Baseline and week 12
The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1). Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+).
次要结局
- Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells(Baseline and week 12)
- Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio(Baseline and week 12)
- Percentage of Participants With Improvement in Marsh Score at Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12(Baseline and week 12)
- Number of Weekly Bowel Movements at Baseline and Week 12(Baseline and week 12)
- Percentage of Participants With Diarrhea at Baseline and Week 12(Baseline and week 12)
- Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12(Baseline and week 12)
- Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12(Baseline and week 12)