NCT01022970已完成2 期
A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13.
研究概览
简要总结
This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-50 with symptomatic eosinophilic esophagitis
- •Female subjects must be women of non child bearing potential.
- •Elimination diet must have been tried.
- •Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
- •Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
- •Must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Understand and sign the written informed consent.
- •Exclusion criteria:
- •Have received corticosteroids within 3 months before starting the study for any symptoms.
- •Any other eosinophilic disorders.
- •History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
- •Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
- •History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: QAX576 placebo (Drug)
QAX576
Active Comparator
干预措施: QAX576 (Drug)
结局指标
主要结局
The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13.
时间窗: 13 weeks
次要结局
- To investigate the safety and tolerability of QAX576 in patients with EoE.(34 weeks)
- To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.(34 weeks)
- To establish the duration of clinical benefit after a 12 week course of therapy.(34 weeks)
- PK/PD relationship between blood levels of QAX576 and IL- 13 dependent gene expression in esophageal biopsies and soluble biomarkers, inflammatory and fibrotic markers within esophageal biopsies and activation markers expressed on peripheral(34 weeks)
研究者
研究点 (5)
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