A safety study for subjects with severe asthma who participated in MEA115575 or MEA115588
- Conditions
- Subjects with Severe Asthma.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 15.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855
- Registration Number
- EUCTR2012-001644-21-ES
- Lead Sponsor
- GlaxoSmithKline, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
2. MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
3. Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., 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.
4. Male or eligible female subjects:
5. 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 (Appendix 2) for the duration of the trial and for 4 months after the last study drug administration.
6. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 620
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. 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.
2. 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.
3. 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]
4. Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
5. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
6. ECG: Baseline ECG which has a clinically significant abnormality or which shows QTcF <=450msec or QTcF <=480msec for subjects with Bundle Branch Block.
7. Smoking status: Current smokers Subjects should also be excluded if any of the following are met:
1. Liver Function: Liver Function Tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 :
- ALT >=2 x ULN (upper limit of normal)
- AST >=2 x ULN
- Alk Phos >=2 x ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety profile of mepolizumab in subjects receiving long-term treatment;Secondary Objective: To evaluate the effects of mepolizumab on a range of clinical markers of asthma control;Primary end point(s): Adverse Events;Timepoint(s) of evaluation of this end point: Each clinic visit.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Each clinic visit;Secondary end point(s): - Frequency of positive anti-mepolizumab binding antibodies and neutralising antibodies.<br>- Annualized rate of exacerbations<br>- ACQ score<br>- FEV1<br>- # of withdrawals due to lack of efficacy<br>- # of withdrawals due to adverse events<br>- # of hospitalisations due to adverse events including asthma exacerbations<br>- Frequency of both systemic (i.e. allergic/IgE-mediated and non-allergic) and local site reactions<br>- 12-lead ECG parameters<br>- Vital signs<br>- Clinical Laboratory Parameters