A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 8
- 主要终点
- Severe asthma exacerbation rate
研究概览
简要总结
The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.
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. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.
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 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 as add-on to oral corticosteroids
Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
干预措施: Masitinib (Drug)
Placebo as add-on to oral corticosteroids
Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
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
- ACQ Score(36 weeks)
- Asthma exacerbation rate(Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months)