NCT00274703已完成2 期
A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Provide a Preliminary Evaluation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Intravenous Anti-human Interleukin-5 (Mepolizumab, 750mg and 1500mg) in the Treatment of Eosinophilic Oesophagitis in Adults
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
研究概览
简要总结
Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.
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
- Double
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
- •Document evidence/presence of Oesophagitis prior to commencing trial drug.
- •a)Histological evidence of Oesophagitis: greater than 20x eosinophils per high power field (X400) on histology of esophageal mucosal biopsy
- •b. at least one episode of dysphagia per week
- •c.Inadequate response to routine EE treatment
- •D. No other known causes of oesophagitis, or esophageal or generalized eosinophilia
- •Not pregnant or nursing
排除标准
- •History of seasonal worsening of EE symptoms or requirement of Esophageal dilation.
- •Churg-Strauss Syndrome
- •Wegener's Granulomatosis
- •Lymphoma, hematological malignancy, advanced and metastatic solid tumors
- •Active H. pylori infection.
- •Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.
结局指标
主要结局
1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
次要结局
- 1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood.
研究者
研究点 (2)
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