NCT00971035已完成2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Change in forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
- •Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
- •Stable asthma
排除标准
- •Asthma exacerbation during screening
- •Known malignancy
- •Known immunodeficiency
- •Pre-existing lung disease other than asthma
- •Uncontrolled clinically significant medical disease
- •Current smoker
- •History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
- •Prior allergic reaction to a monoclonal antibody
- •Patients (men and women) of reproductive potential who are not willing to use contraception
- •Pregnancy
研究组 & 干预措施
A
Experimental
干预措施: lebrikizumab (MILR1444A) (Drug)
B
Experimental
干预措施: lebrikizumab (MILR1444A) (Drug)
C
Experimental
干预措施: lebrikizumab (MILR1444A) (Drug)
D
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in forced expiratory volume in 1 second (FEV1)
时间窗: Baseline to Week 12
次要结局
- Change in pre-bronchodilator FEV1(Baseline to Week 24)
- Rate of asthma exacerbations(During the 24-week treatment period)
- Change in quality of life and symptom scores(Baseline to Week 12)
- Change in peak flow(Baseline to Week 1)
- Change in rescue medication use(From baseline to Week 1)
- Frequency and severity of adverse events(From the first study-specific procedure through the last observation visit)
- Incidence of human anti-therapeutic antibodies (ATA)(Baseline to Week 32)
研究者
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