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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2023

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAIN
  • Sponsors Alexion AstraZeneca Rare Disease; Alexion Pharmaceuticals

    • Most Recent Events

    • 13 Jun 2023 According to an Alexion AstraZeneca Rare Disease, based on comprehensive results from this study Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
    • 18 May 2022 Results assessing comparative clinical efficacy and cost-effectiveness in patients with myasthenia gravis using data from three clinical studies: ADAPT, REGAIN and GTI1408 presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 04 Mar 2021 According to an Alexion Pharmaceuticals media release, data from this trial will be presented at 73rd annual meeting of the American Academy of Neurology (AAN)
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