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An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Trial Profile

An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 23 Feb 2026

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Myasthenia gravis
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms Vibrance-MG
  • Sponsors Janssen Research & Development

Most Recent Events

  • 17 Feb 2026 Planned End Date changed from 26 Jun 2026 to 2 Jul 2029.
  • 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.
  • 29 Oct 2025 According to the Johnson and Johnson Media Release, long-term extension (LTE) data will present at the 2025 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting.

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