NCT01508936已完成3 期
A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe 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
- 511
- 试验地点
- 65
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set
研究概览
简要总结
The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- •The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
- •The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
- •The patient has known hypereosinophilic syndrome (HES).
- •The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
- •The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
- •The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
- •The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
- •The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease).
- •The patient has participated in any investigative drug or device study within 30 days prior to screening.
- •The patient has participated in any investigative biologics study within 90 days prior to screening.
- •The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
- •The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- •The patient has a current infection or disease that may preclude assessment of asthma.
- •The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency).
- •The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- •The patient has presence of or suspected parasitic infestation/infection.
- •Patients may not have received any live attenuated vaccine within the 12-week period before study entry.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo intravenous injection every 4 weeks for a total of 4 doses.
干预措施: Placebo (Drug)
Reslizumab 3.0 mg/kg
Experimental
Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
干预措施: Reslizumab (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set
时间窗: Baseline (Day 1), Week 16
FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10\^9/liter) by treatment group.
次要结局
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures(Baseline (Day 1), Weeks 4, 8, 12, 16)
- Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures(Baseline (Day 1), Weeks 4, 8, 12, 16)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation(Baseline (Day 1), Week 16)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16(Baseline (Day 1), Weeks 4, 8, 12, and 16)
- Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint(Baseline (Day 1), Weeks 4, 8, 12, and 16)
- Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16(Baseline (Day 1), Weeks 4, 8, 12, and 16)
- Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16(Baseline (Day 1), Weeks 4, 8, 12, and 16)
- Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16(Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16)
- Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint(Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28))
- Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16(Baseline (Day 1), Weeks 4, 8, 12 and 16)
- Participants With Treatment-Emergent Adverse Events(Day 1 to Week 28)
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values(Week 4 to Week 16)
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values(Week 4 to Week 28)
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities(Week 16 or endpoint)
- Participants With a Positive Anti-Reslizumab Antibody Status During Study(Screening (Week -3), Weeks 8 and 16)
研究者
研究点 (65)
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