NCT01902290终止2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 421
- 试验地点
- 162
- 主要终点
- Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
研究概览
简要总结
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
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
- •Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening
- •Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
- •Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
- •Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points
排除标准
- •History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
- •History of allergic bronchopulmonary aspergillosis
- •Respiratory infection within 4 weeks of screening or 1 week of baseline visit
- •Subject has known history of Crohn's disease
- •Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
- •Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
- •Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
- •Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
- •Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
- •Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
结局指标
主要结局
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
时间窗: Baseline and week 24
The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment. The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of \< 1.0 indicates good asthma control.
次要结局
- Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation(Baseline and week 24)
- Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)(Baseline and week 24)
- Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)(Baseline and week 24)
- Asthma Exacerbation Rate(Baseline to week 24)
- Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)(Baseline and week 24)
- Asthma Exacerbation Rate in ICS+LABA Subpopulation(Baseline to week 24)
- Time to First Asthma Exacerbation(From first dose of study drug to week 24)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score(Baseline and week 24)
- Change From Baseline in Variation of Peak Flow(Baseline and week 24)
- Serum Brodalumab Concentration(Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days)
- Change From Baseline in Daily Rescue Short-acting Beta-agonist Use(Baseline and week 24)
- Number of Participants Who Experienced an Asthma Exacerbation(Baseline to week 24)
- Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period(Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24)
研究者
研究点 (162)
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