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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: 15 Dec 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

  • 02 Dec 2025 According to Johnson & Johnson media release, the European Commission has approved a Marketing Authorisation for IMAAVY(nipocalimab), as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). supported by the data from Vivacity-MG3 and Vibrance-MG trials.
  • 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.

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