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: 16 Aug 2017

At a glance

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

    • 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.
    • 17 Jun 2017 Results presented at the 18th Annual Congress of the European League Against Rheumatism
    • 10 Jun 2017 Biomarkers information updated
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top