NCT01402986已完成2 期
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 689
- 试验地点
- 90
- 主要终点
- Annual Asthma Exacerbation Rate (AER)
研究概览
简要总结
The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.
详细描述
Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.
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
- •Age 18-75 years
- •Body mass index (BMI) between 16-40 kilogram per square meter (kg/m^2) at Visit 1
- •Uncontrolled severe asthma
- •A chest x-ray with no abnormality
- •Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
- •Non-sterilized males or sterilized males who are less than or equal to (=<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception
排除标准
- •Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
- •Pregnant or breastfeeding women
- •Any other respiratory disease
- •Previously taken tralokinumab (the study drug)
- •Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
- •Known immune deficiency
- •History of cancer
- •Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
- •Any disease which may cause complications whilst taking the study drug.
结局指标
主要结局
Annual Asthma Exacerbation Rate (AER)
时间窗: Week 1 up to Week 53
Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.
次要结局
- Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53(Baseline and Week 53)
- Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53(Baseline and Week 53)
- Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53(Baseline and Week 53)
- Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53(Baseline and Week 53)
- Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53(Baseline and Week 53)
- Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home(Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53))
- Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home(Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53))
- Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53(Baseline and Week 53)
- Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53(Baseline and Week 53)
- Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53(Week 53)
- Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53(Baseline and Week 53)
- Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53(Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53))
- Change From Baseline in Rescue Medication Use at Week 53(Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)(Baseline and Week 75)
- Observed Serum Tralokinumab Concentration at Week 53(Week 53)
- Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab(Baseline and Week 75)
- Severe Annual Asthma Exacerbation Rate (AER)(Week 1 up to Week 53)
- Time to First Exacerbation Through Week 53(Week 1 up to Week 53)
- Time to First Severe Exacerbation Through Week 53(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year(Week 1 up to Week 53)
- Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin(Week 1 up to Week 53)
- Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility(Week 1 up to Week 53)
- Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status(Week 1 up to Week 53)
- Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count(Week 1 up to Week 53)
- Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups(Week 1 up to Week 53)
- Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups(Week 1 up to Week 53)
- Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status(Week 1 up to Week 53)
- Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use(Week 1 up to Week 53)
- Change From Baseline in Percentage of Nighttime Awakening at Week 53(Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53))
- Change From Baseline in Overall Activity Limitations at Week 53(Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53))
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53(Baseline and Week 53)
- Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53(Baseline and Week 53)
- Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53(Baseline and Week 53)
- Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53(Baseline and Week 53)
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home(Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53))
- Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home(Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53))
研究者
研究点 (90)
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