A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib Versus Placebo in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 5
- 主要终点
- Severe asthma exacerbation rate
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.
详细描述
Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.
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 (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Masitinib (titration to 6.0 mg/kg/day)
Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control.
干预措施: Masitinib (Drug)
Placebo
Participants receive matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Severe asthma exacerbation rate
时间窗: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
The number of severe asthma exacerbations over time frame of outcome measure
次要结局
- Asthma Control Questionnaire (ACQ)(48 weeks)
- Asthma exacerbation rate(Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months)