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A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease

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Trial Profile

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs Teprotumumab (Primary)
  • Indications Graves ophthalmopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIC
  • 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.
    • 26 Jun 2023 According to a Horizon Therapeutics media release, based on this trial the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.
    • 18 Jun 2023 Results of pooled analysis from European Study Sites Participating in the Phase 2, OPTIC (Phase 3) and OPTIC-X trials , presented at the 105th Annual Meeting of the Endocrine Society
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