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NCT03298061 · ClinicalTrials.gov registry record · Phase 3
Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT03298061 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 100 participants.
The verdict
NCT03298061, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study 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.
Interventions
- DRUG Prednisolone
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-04-14 |
| Est. Completion | 2023-02-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03298061
The ClinicalTrials.gov registry entry for NCT03298061 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prednisolone is the first listed.
NCT03298061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03298061 about?
NCT03298061 is a clinical study titled "Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921". 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...
What is the current status of trial NCT03298061?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2015-04-14. Estimated completion is 2023-02-16.
What interventions are being tested in trial NCT03298061?
The interventions under investigation include: Prednisolone (DRUG), Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT03298061?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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