NCT02104674已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 82
- 主要终点
- Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 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)
盲法说明
Participants and investigators will remain blinded to the lebrikizumab and placebo arms only. Montelukast will be administered in tablet form and given in an open-label fashion.
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 18-75 years old at study start
- •Asthma diagnosis for >/= 12 months prior to study start
- •Bronchodilator response at screening
- •Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3
- •No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan
- •Stable and symptomatic asthma during the screening period
- •Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose
排除标准
- •Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
- •Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event
- •Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start
- •Documented prior treatment failure with Montelukast
- •Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study
- •Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start
- •Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
- •History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
- •History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
- •Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
- •Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab
- •Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- •Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening
- •Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
- •Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening
- •Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening
- •Pregnancy or breast feeding
- •Body mass index > 38 kg/m2
- •Body weight < 40 kg
- •History of bronchial thermoplasty
研究组 & 干预措施
Singulair (montelukast)
Active Comparator
干预措施: montelukast [Singulair] (Drug)
lebrikizumab
Experimental
干预措施: lebrikizumab (Drug)
结局指标
主要结局
Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
时间窗: From Baseline to Week 12
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
时间窗: Baseline through Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the second for the montelukast vs. placebo sensitivity comparison.
次要结局
- Relative change in morning pre-bronchodilator peak expiratory flow (PEF)(From Baseline to Week 12)
- Time to treatment failure(From Baseline to Week 12)
- Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax)(Week 1)
- Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S))(From Baseline to Week 12)
- Change in asthma rescue medication use(From Baseline to Week 12)
- Incidence of adverse events(Approximately 20 weeks)
- Pharmacodynamics: Change in blood eosinophil count(From Baseline to Week 12)
- Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO)(From Baseline to Week 12)
- Change From Baseline in C-C Motif Chemokine Ligand 13 (CCL-13) Levels at Week 12(Baseline, Week 12)
- Change From Baseline in CCL-17 Levels at Week 12(Baseline, Week 12)
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels at Week 12(Baseline, Week 12)
- Change From Baseline in Serum Periostin at Week 12(Baseline, Week 12)
- Change From Baseline in Total Immunoglobulin E (IgE) Levels at Week 12(Baseline, Week 12)
- Lebrikizumab vs. Placebo: Change From Baseline in Asthma Reliever Medication Use at Week 12(Baseline through Week 12)
- Lebrikizumab vs. Placebo: Change From Baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Week 12(Baseline through Week 12)
- Montelukast vs. Placebo: Change Fom Baseline in Morning Pre-bronchodilator Peak Expiratory Flow (PEF) at Week 12(Baseline through Week 12)
- Lebrikizumab vs. Placebo: Change From Baseline in Morning Pre-bronchodilator PEF at Week 12(Baseline through Week 12)
- Lebrikizumab vs. Placebo: Number of Participants With Treatment Failure(Baseline up to Week 12)
- Lebrikizumab vs. Placebo: Time to Treatment Failure(Basleine up to Week 12)
- Change From Baseline in Blood Eosinophil Count at Week 12(Baseline, Week 12)
- Maximum Serum Lebrikizumab Concentration (Cmax) After the First Dose(Predose on Day 0 and post-Day 1 dose on Day 7)
- Time to Reach Maximum Lebrikizumab Concentration After the First Dose (Tmax)(Post-Day 1 dose on Day 7)
- Elimination Half-Life (t1/2) of Lebrikizumab(Predose on Days 0, 28, and 56, and on Days 7, 84, 112, and 140)
- Predose Serum Lebrikizumab Concentration (Cmin) at Week 4(Predose on Day 28 (Week 4))
- Serum Lebrikizumab Concentration at Week 12(On Day 84 (Week 12))
研究者
研究点 (82)
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