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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: 08 May 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

    • 01 May 2024 Status changed from recruiting to active, no longer recruiting.
    • 30 Apr 2024 According to an Ultragenyx Pharmaceutical media release, In the event of a positive interim analysis, the patients will complete a final visit prior to transitioning to the open-label extension study and reporting of topline results.
    • 30 Apr 2024 According to an Ultragenyx Pharmaceutical media release, there are 2 planned interim analyses for this study, and the 1st is anticipated by year-end/ early 2025 based on the timing of enrollment. The 1st analysis will have a stringent threshold of p = 0.001. If the threshold is not met, a 2nd interim analysis will occur a few months after, followed by a final analysis at 18 months. Interim analyses will not be reported to the company by the data monitoring committee unless they are positive.
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