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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

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Trial Profile

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 15 Jul 2024

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At a glance

  • Drugs Teprotumumab (Primary)
  • Indications Graves ophthalmopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms Chronic TED Trial
  • Sponsors Horizon Pharma USA
  • Most Recent Events

    • 26 Apr 2024 According to an Amgen media release, the company announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. The MAA is supported by clinical studies NCT01868997, NCT03298867, NCT04583735, and, jRCT2031210453.
    • 02 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 29 Sep 2023 Results presented in a Horizon Therapeutics plc media release.
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