NCT01842607已完成3 期
A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 651
- 试验地点
- 138
- 主要终点
- Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions
研究概览
简要总结
This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
- •MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA
- •Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids [ICS] or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
- •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.
- •A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.
排除标准
- •Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
- •Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
- •Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]
- •Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
- •Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- •ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) >=450 millisecond (msec) or QTcF >=480 msec for subjects with Bundle Branch Block.
- •Smoking status: Current smokers
- •Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) >=2 x upper limit of normal (ULN); aspartate transaminase (AST) >=2 x ULN; alkaline phosphatase >=2 x ULN; Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%
- •Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1
- •ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575
研究组 & 干预措施
Mepolizumab Arm
Experimental
Subjects will receive 100 mg of Mepolizumab (in polypropylene syringe) injected subcutaneously (SC) once every 4 weeks for 12 months
干预措施: Mepolizumab (Biological)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions
时间窗: From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])
AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.
次要结局
- Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Annualized Rate of Exacerbations Per Year(Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose)
- Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Number of Participants Hospitalized Due to Exacerbations and Adverse Events(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period(From Baseline and up to Week 52)
- Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Change From Baseline in Pulse Rate Assessed at Week 52(Baseline and Week 52)
- Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
- Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52(Baseline and Week 52)
- Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline(From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]))
研究者
研究点 (138)
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