Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Status:
Active, not recruiting
Trial end date:
2022-07-29
Target enrollment:
Participant gender:
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 interleukin-5 (IL-5) is a key cytokine regulating the life-cycle
of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody,
therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921
was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the
subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo
subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care
therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8
weeks to study completion at Week 60. This is a LAP to support provision of open-label
mepolizumab on an individual basis to eligible subjects who participated in clinical study
MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day
(mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under
this LAP within a 6-month period starting from completion of study MEA115921 (that is, at
Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will
initiate mepolizumab at the time point that would have been Week 60 if the subject had
completed the study. Eligible subjects will receive subcutaneously administered mepolizumab
at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab
under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the
relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject
meets any of the withdrawal/stopping criteria.