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A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)

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Trial Profile

A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Oct 2024

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At a glance

  • Drugs Setrusumab (Primary) ; Zoledronic acid (Primary) ; Calcium; Vitamin D
  • Indications Osteogenesis imperfecta
  • Focus Therapeutic Use
  • Acronyms ASTEROID
  • Sponsors Ultragenyx Pharmaceutical

    • Most Recent Events

    • 07 Oct 2024 According to a Ultragenyx Pharmaceutical media release, based on result from Orbit and ASTEROID study, the company has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for setrusumab (UX143) as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta (OI) Type I, III, or IV in patients 2 years of age and older.
    • 02 Sep 2024 Results evaluating the efficacy and safety of setrusumab published in the Journal of Bone and Mineral Research.
    • 02 Sep 2024 Results assessing the bone matrix material properties in tetracycline-labeled trans iliac biopsies from 3 groups: control: individuals with no metabolic bone disease, OI: individuals with OI and SclAb-OI: individuals with OI after 6 mo of setrusumab treatment (as part of the ASTEROID trial), published in the Journal of Bone and Mineral Research.

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