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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2025

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At a glance

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

Most Recent Events

  • 19 Sep 2025 According to Johnson & Johnson media release, based on results form this trial, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of nipocalimab as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG).
  • 09 Sep 2025 Number of treatment arms have been increased from 2 to 3 by the addition of Experimental: Nipocalimab Subcutaneous (SC) arm.
  • 23 Jul 2025 Status changed from recruiting to active, no longer recruiting.

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