A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Ph 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults With Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 79
- 试验地点
- 16
- 主要终点
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils
研究概览
简要总结
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.
详细描述
This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately 80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
- •Documented treatment with an asthma controller regimen requiring treatment with ICS (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
- •Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v
- •At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1>50% and more than 1L.
- •Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).
排除标准
- •History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma.
- •History of anaphylaxis following any biologic therapy.
- •Hepatitis B, C or HIV
- •Pregnant or breastfeeding
- •History of cancer
- •Current tobacco smoking or a history of tobacco smoking for >10 pack-years.
- •Previous receipt of tralokinumab
研究组 & 干预措施
Placebo Dose Regimen
Placebo Subcutaneous Injection
干预措施: Placebo (Other)
Tralokinumab Dose Regimen
Tralokinumab Subcutaneous Injection
干预措施: Tralokinumab (Biological)
结局指标
主要结局
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils
时间窗: Baseline (Week 0) and Week 12
The number of airway submucosal eosinophils per millimetre squared (mm\^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.
次要结局
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations(Baseline (Week 0) and Week 12)
- Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations(Baseline (Week 0) and Week 12)