临床试验/NCT02098473

NCT02098473已完成2 期

A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis

Celgene30 个研究点分布在 3 个国家目标入组 100 人开始时间: 2014年8月31日最近更新: 2017年5月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Celgene
入组人数: 100
试验地点: 30
主要终点: Mean Eosinophil Count

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologic evidence of EoE
•Clinical symptoms of EoE including dysphagia

排除标准

•Primary causes of esophageal eosinophilia other than EoE

研究组 & 干预措施

RPC4046 Low Dose

Experimental

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose

干预措施: RPC4046 (Drug)

RPC4046 High Dose

Experimental

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose

干预措施: RPC4046 (Drug)

Placebo

Placebo Comparator

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Mean Eosinophil Count

时间窗: Week 16

次要结局

未报告次要终点

研究者

发起方

Celgene

申办方类型

Industry

责任方

Sponsor

研究点 (30)

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