A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 226
- 主要终点
- Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment
研究概览
简要总结
The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent is obtained.
- •The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
- •The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
- •The participant has required an inhaled corticosteroid.
- •The participant has required an additional asthma controller medication besides inhaled corticosteroids.
- •The participant has a history of asthma exacerbation.
- •The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- •Additional criteria may apply, please contact the investigator for more information
排除标准
- •The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
- •The participant has another confounding underlying lung disorder
- •The participant has a known hypereosinophilic syndrome.
- •The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- •The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
- •The participant is a current smoker or has a smoking history.
- •The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- •The participant was previously exposed to reslizumab.
- •The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
- •The participant has current or suspected drug and alcohol abuse.
- •The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
- •The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.
- •Additional criteria may apply, please contact the investigator for more information
研究组 & 干预措施
Reslizumab
Reslizumab
干预措施: Reslizumab (Drug)
Placebo
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment
时间窗: Day 1 to Week 52
A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.
次要结局
- Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline, Week 52)
- Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score(Baseline, Week 52)
- Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score(Baseline, Week 32)
- Percentage of Asthma Control Days(Day 1 to Week 52)
- Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52(Day 1 to Week 52)
- Number of Moderate Exacerbations During 52 Weeks of Treatment(Day 1 to Week 52)
- Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score(Baseline, Week 52)
- Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)(Baseline, Week 52)
- Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment(Day 1 to Week 52)