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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Rozanolixizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms MycarinG study
  • Sponsors UCB Biopharma

Most Recent Events

  • 03 Apr 2025 According to an UCB media release, data from post-hoc analysis of this study will be presented at American Academy of Neurology (AAN) meeting, San Diego California, April 5- 9, 2025.
  • 02 Apr 2025 According to an UCB media release, injection therapy Rystiggo (rozanolixizumab-noli) has been granted regulatory approval in Canada for adults with generalized myasthenia gravis (gMG) who test positive for antibodies against the acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) proteins. This approval of Rystiggo was supported by data from the Phase 3 MycarinG trial.
  • 31 Jan 2025 According to an UCB media release, CHMP (Committee for Medicinal Products for Human Use) has issued a positive opinion for the self-administration of RYSTIGGO (rozanolixizumab) via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional based on this trial

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