NCT00967590撤回2 期
A Multi-center, Randomized, Double-Blind, Multiple-Dose, Placebo-controlled Asthma Control Study Evaluating the Efficacy, Safety, and Tolerability of RO5036505 in Subjects With Moderate-to-Severe Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age
- •moderate to severe asthma for >/=2 years
- •ACQ score >/= 1.5
- •ICS and LABA regimen at moderate to high dose
- •non-smokers
排除标准
- •oral corticosteroid use within 4 weeks prior to screening
- •current escalating immunotherapy
- •acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection
- •pulmonary disease other than asthma
- •therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening
- •previous exposure to investigational monoclonal antibodies or biologics
研究组 & 干预措施
1
Experimental
干预措施: RO5036505 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
时间窗: assessed every week, laboratory parameters every 3-4 weeks, up to day 95
ACQ questionnaire, spirometry assessments, PEFR
时间窗: every week up to day 95
次要结局
- Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance(sampling every week up to day 95)
研究者
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