NCT02054130已完成2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma
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
- 584
- 试验地点
- 1
- 主要终点
- Annualized Asthma Exacerbation Rate (AER) Through Week 52
研究概览
简要总结
The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, 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
- Double (Participant, Investigator)
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 through 75
- •Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg
- •Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
排除标准
- •Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
- •Current smokers or subjects with a smoking history of ≥ 10 pack years
- •Former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.
- •Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).
- •Evidence of active liver disease.
- •History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)
- •History of anaphylaxis to any biologic therapy
- •Positive medical history for hepatitis B or C
- •Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
干预措施: Placebo (Drug)
MEDI9929 70 mg
Experimental
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
干预措施: MEDI9929 70 mg (Drug)
MEDI9929 210 mg
Experimental
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
干预措施: MEDI9929 210 mg (Drug)
MEDI9929 280 mg
Experimental
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
干预措施: MEDI9929 280 mg (Drug)
结局指标
主要结局
Annualized Asthma Exacerbation Rate (AER) Through Week 52
时间窗: Week 0 (Day 1) up to Week 52
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
次要结局
- Reduction in AER on Subpopulations at Week 52(Week 52)
- Rate of Severe Asthma Exacerbation Through Week 52(Week 0 (Day 1) up to Week 52)
- Time to First Asthma Exacerbation Through Week 52(Week 0 (Day 1) through Week 52)
- Time to First Severe Asthma Exacerbation Through Week 52(Week 0 (Day 1) through Week 52)
- Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52(Week 0 (Day 1) through Week 52)
- Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52(Baseline (Week 0 [Day 1]) and Week 52)
- Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52(Baseline (Week 0 [Day 1]) to Week 52)
- Change From Baseline in FEV1 on Subpopulations at Week 52(Baseline and up to Week 52)
- Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52(Baseline (Week 0 [Day 1]) to Week 52)
- Number of Participants With at Least One Asthma Exacerbations Through Week 52(Week 0 (Day 1) through Week 52)
- Number of Participants With TEAEs Related to Electrocardiogram Evaluations(From the start of study drug administration upto Week 64)
- Mean Serum Concentrations of MEDI9929(Week 0 (Day 1) to Week 64)
- Number of Participants With Positive Antibodies to MEDI9929(Week 0 (Day 1) to Week 64)
- Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52(Baseline and up to Week 52)
- Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52(Baseline (Week 0 [Day 1]) and Week 52)
- Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52(Baseline (Week 0 [Day 1]) and Week 52)
- Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52(Baseline (Week 0 [Day 1]) and Week 52)
- Total Amount of Study Drug Exposure(Week 0 (Day 1) through Week 52)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Day 1 upto Week 64)
- Number of Participants With TEAEs Related to Vital Sign Parameters(Day 1 upto Week 64)
- Number of Participants With TEAEs Related to Clinical Laboratory Evaluation(Day 1 upto Week 64)
研究者
研究点 (1)
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