A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
研究概览
简要总结
The purpose of this study is to determine if AMG 827 is 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
- 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
- •Men or women 18 to 65 years of age
- •Percent of predicted FEV1 ≥ 50% and ≤ 80%
- •At least 12% reversibility over pre-bronchodilator FEV1
- •Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
- •Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points
排除标准
- •Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
- •History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- •Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)
研究组 & 干预措施
Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
干预措施: Placebo (Drug)
AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
干预措施: AMG 827 (Drug)
AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
干预措施: AMG 827 (Drug)
AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
干预措施: AMG 827 (Drug)
结局指标
主要结局
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
时间窗: Baseline and Week 12
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
次要结局
- Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12(Baseline to Week 12)
- Change From Baseline in Daily Asthma Symptom Score to Week 12(Baseline and Week 12)
- Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12(Baseline and Week 12)
- Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline and Week 12)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12(Baseline and Week 12)
- Proportion of Asthma Symptom-free Days(Up to Week 12)
- Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10(Week 8 (days 60 and 64), and pre-dose on Week 10)
- Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10(Week 8 (days 60 and 64), and pre-dose on Week 10)
- Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10(Week 8 (days 60 and 64), and pre-dose on Week 10)