Status:
COMPLETED
Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Lead Sponsor:
GlaxoSmithKline
Conditions:
Churg-Strauss Syndrome
Eosinophilic Granulomatosis With Polyangiitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and inte...
Eligibility Criteria
Inclusion
- Subject participated in study MEA115921.
- Subject has either: a) completed study MEA115921 to Week 60, that is, completion of follow up period, or b) if the subject was withdrawn prematurely from study MEA115921, the subject has reached the date of what would have been the Week 60 if the subject had completed the study, that is, 60 weeks from Baseline (Visit 2).
- At or up to 6 months after the MEA115921 Week 60 time- point the subject requires a dose of prednisolone (or equivalent) of \>=5 mg/day for adequate control of their EGPA.
- The treating physician requesting mepolizumab under this LAP considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
- To be eligible for mepolizumab treatment under this LAP, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.
- The subject consents to receiving treatment with mepolizumab under this LAP.
Exclusion
- A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (that is, basal or squamous cell) of the skin which was resected for cure will not be excluded).
- Subject has other clinically significant medical conditions uncontrolled with standard of care therapy not associated with EGPA, example, unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease requiring systemic treatment.
- Subject is pregnant or breastfeeding. Subjects should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
- Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.
- Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in study MEA115921 which resulted in permanent withdrawal of study treatment.
- Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or intravenous (IV) immunoglobulin therapy without prior agreement from the GSK Medical Monitor.
- Subjects who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to initiation of mepolizumab treatment under this LAP (this also includes investigational formulations of marketed products).
- Subject is currently participating in any other interventional clinical study.
Key Trial Info
Start Date :
April 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03298061
Start Date
April 14 2015
End Date
February 16 2023
Last Update
March 12 2024
Active Locations (32)
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1
GSK Investigational Site
Denver, Colorado, United States, 80206
2
GSK Investigational Site
Bethesda, Maryland, United States, 20892
3
GSK Investigational Site
Boston, Massachusetts, United States, 02118-2307
4
GSK Investigational Site
Boston, Massachusetts, United States, 02215