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An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

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Trial Profile

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

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

Latest Information Update: 17 Jul 2024

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At a glance

  • Drugs Setrusumab (Primary) ; Bisphosphonates
  • Indications Osteogenesis imperfecta
  • Focus Registrational; Therapeutic Use
  • Acronyms Orbit
  • Sponsors Ultragenyx Pharmaceutical

    • Most Recent Events

    • 11 Jun 2024 According to an Ultragenyx Pharmaceutical media release, Phase 3 portion of the study has enrolled an additional 158 patients at 45 sites across 11 countries. patients will transition to an extension period and receive open-label setrusumab after the Phase 3 primary analysis is complete.
    • 11 Jun 2024 According to an Ultragenyx Pharmaceutical Media Release, detailed 14-month data will be presented at a future scientific meeting.
    • 11 Jun 2024 14-month positive phase 2 data presented in an Ultragenyx Pharmaceutical Media Release.
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