MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)
研究概览
简要总结
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent.
- •MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
- •MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio.
- •Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.
- •Male or Eligible Female Subjects. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.
排除标准
- •Hypersensitivity related to mepolizumab.
- •Clinically significant change in health status since completing participation in the MEA112997 trial.
- •A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- •For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.
- •Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- •Screening ECG which has a clinically significant abnormality.
- •Received Xolair (omalizumab) within the past 130 days.
- •Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit, whichever is longer.
- •Current smokers.
研究组 & 干预措施
Mepolizumab
Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
干预措施: Mepolizumab (Drug)
结局指标
主要结局
Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)
时间窗: Baseline (Week 0) to Week 240
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.
次要结局
- Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)(Baseline (Week 0) to Week 240)
- Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])(Baseline (Week 0) to Week 240)
- Number of Participants With Clinical Chemistry Data of Potential Clinical Concern(Baseline (Week 0) to Week 240)
- Number of Participants Who Withdrew Due to Lack of Efficacy(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])(Baseline (Week 0) to Week 240)
- Number of Participants With Hematology Data of Potential Clinical Concern(Baseline (Week 0) to Week 240)
- Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in Vital Signs-Sitting Pulse Rate(Baseline (Week 0) to Week 240)
- Annualized Rate of On-treatment Exacerbations(Baseline (Week 0) to Week 240)
- Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score(Baseline (Week 0) to Week 240)
- Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline (Week 0) to Week 240)
- Number of Participants Who Withdrew Due to AE(Baseline (Week 0) to Week 240)