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An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV

Trial Profile

An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV

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

Latest Information Update: 19 May 2025

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At a glance

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

Most Recent Events

  • 13 May 2025 According to a Ultragenyx Pharmaceutical media release, If Orbit progresses to full study completion in the fourth quarter of 2025, Cosmic will also continue to a data readout, to align with the Orbit readout without spending alpha at the mid-year interim assessment.
  • 13 Feb 2025 According to a Ultragenyx Pharmaceutical media release, study also are continuing to be treated with either setrusumab or intravenous bisphosphonates (IV-BP) therapy and will be evaluated in parallel with the Orbit interim and final analyses.
  • 12 Jan 2025 According to a Ultragenyx Pharmaceutical media release, company expects interim analysis in mid-2025 and a potential final analysis in the fourth quarter 2025.

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