A safety study for subjects with severe asthma who participated in MEA115575 or MEA115588

• Conditions: Subjects with Severe Asthma; MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001644-21-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-20
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

1. Informed Consent: Prior to commencing any study related activities,
subjects must be able and willing to provide written informed consent.
2. MEA115588 or MEA11575 study completion: Completion of the double
blind investigational product treatment during MEA115588 or
MEA11575.
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 therapy through the end of
MEA115588 or MEA115575. 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 of childbearing
potential at the initial Baseline Visit (Visit 1). In addition, a urine
pregnancy test will be performed for all females of childbearing potential
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 522
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

Exclusion Criteria

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

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
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<br>;Timepoint(s) of evaluation of this end point: Each clinic visit