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Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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Trial Profile

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms Vivacity-MG3
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 23 Jun 2025 According to Johnson & Johnson media release, data from this trial was featured at the European Academy of Neurology (EAN) 2025 Congress in Helsinki, Finland, are among the 11 abstracts Johnson & Johnson is presenting.
  • 23 Jun 2025 Results presented in the Johnson & Johnson media release.
  • 30 Apr 2025 According to Johnson & Johnson media release, announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study.

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