Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03298061
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2017-09-27
Brief Title:
Long-term Access Program LAP of Mepolizumab for Subjects Who Participated in Study MEA115921
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT00244686
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
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 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 mgday 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 withdrawalstopping criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-003162-25 | EUDRACT_NUMBER | None | None |