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A Multicenter, Double-Masked, Placebo-Controlled, Efficacy And Safety Study Of RV 001, An Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks (q3W) By Intravenous (IV) Infusion In Patients Suffering From Active Thyroid Eye Disease (TED)

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Trial Profile

A Multicenter, Double-Masked, Placebo-Controlled, Efficacy And Safety Study Of RV 001, An Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks (q3W) By Intravenous (IV) Infusion In Patients Suffering From Active Thyroid Eye Disease (TED)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs Teprotumumab (Primary)
  • Indications Graves ophthalmopathy
  • Focus Therapeutic Use
  • Sponsors Horizon Pharma; River Vision Development Corp

    • 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.
    • 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
    • 01 Jul 2022 Results of post hoc analysis from NCT01868997 and NCT03298867 evaluating variability in the time taken to manifest a clinically significant response to teprotumumab, published in the Eye
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