Mepolizumab for the treatment of severe asthma

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 347

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
2. MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
3. MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio in the opinion of the investigator.
4. Current Anti-Asthma Therapy: Asthma is currently being treated with a controller 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.
5. 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 (see Appendix 2 of protocol) 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 Screening Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to Visit 2, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Immunogenicity: Positive neutralizing antibody status based on the last sample obtained during the MEA 112997 study.
2. Hypersensitivity: Report of a hypersensitivity reaction assessed as related to mepolizumab that led to patient withdrawal. Subjects who experienced a localized injection-site reaction do not need to be excluded.
3. Health Status: Clinically significant change in health status since completing participation in the MEA112997 trial which in the opinion of the investigator would make the subject unsuitable for participation in this long term study.
4. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to:
· known ejection fraction of <30% OR
· severe heart failure meeting New York Heart Association Class IV (see Appendix 6) classification OR
· hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III (see Appendix 6) OR
· angina diagnosed less than 3 months prior to Visit 1 or at Visit 1
5. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (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]
6. Prior SAE: For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator
7. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
8. ECG: Screening ECG which has a clinically significant abnormality or which shows QTcF > 450msec or QTcF >480msec for subjects with Bundle Branch Block.
9. Xolair: Received Xolair (omalizumab) within the past 130 days
10. Clinical trial: 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.
11. Smoking status: Current smokers

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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