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A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

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Trial Profile

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

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

Latest Information Update: 29 May 2026

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At a glance

  • Drugs Inebilizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms MINT
  • Sponsors Viela Bio

Most Recent Events

  • 15 May 2026 Planned End Date changed from 29 Nov 2027 to 7 Jun 2029.
  • 12 Feb 2026 According to Amgen media release, the European Commission (EC) has approved UPLIZNA (inebilizumab) as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or antimuscle specific tyrosine kinase (MuSK) antibody positive. The approval supported by data from this trial.
  • 11 Dec 2025 According to Amgen media release, based on the data from this trial- the USFDA has approved inebilizumab-cdon (UPLINZA) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

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