A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy

Trial Profile

A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2017

At a glance

  • Drugs Mepolizumab (Primary)
  • Indications Churg-Strauss syndrome; Granulomatosis
  • Focus Registrational; Therapeutic Use
  • Acronyms MIRRA
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 12 Dec 2017 According to a GlaxoSmithKline media release, the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome. The approval was based on the results of this trial.
    • 08 Nov 2017 Results of a post-hoc analysis assessing oral corticosteroid reduction, and/or relapses, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 28 Jun 2017 According to a GlaxoSmithKline media release, the company has submitted a supplemental Biologics License Application (sBLA) to the US FDA, seeking approval of mepolizumab as an add-on therapy to corticosteroids for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). The regulatory submission was based on the results of this trial.
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