A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2017

At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAIN
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 13 Sep 2017 According to an Alexion Pharmaceuticals media release, James F. Howard is a lead investigator of the study.
    • 21 Aug 2017 According to an Alexion media release supplemental new drug application in Japan for Soliris as a treatment for patients with anti-AChR antibody-positive refractory gMG have been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW).
    • 21 Aug 2017 According to an Alexion Pharmaceuticals media release, European Commission (EC) has approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
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