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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: 08 Apr 2025

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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

  • 15 Mar 2025 Results verifiying the accuracy of timelapse imaging and then using it on longitudinal scans (baseline, 6, 12, 18, and 24 mo) from 78 participants to assess bone formation and resorption induced by an anabolic (setrusumab) and anti-catabolic (zoledronic acid) treatments as part of the ASTEROID trial published in the Journal of Bone and Mineral Research
  • 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.

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