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An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of an Autoinjector for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 204959)

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Trial Profile

An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of an Autoinjector for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 204959)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

  • Drugs Mepolizumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 20 May 2020 Results assessing post-hoc descriptive analysis of a patient experience in those who had previously used mepolizumab and then switched to self-administration using an autoinjector, presented at the 116th International Conference of the American Thoracic Society.
    • 11 Jun 2019 Romania was a planned location.
    • 06 Jun 2019 According to a GlaxoSmithKline media release, based on the data of NCT03099096 & NCT03021304, the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA).

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