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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

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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: 13 May 2026

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At a glance

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

Most Recent Events

  • 12 Jan 2026 According to a Ultragenyx media release, data from this trial will be presented at the J.P. Morgan Healthcare Conference.
  • 29 Dec 2025 According to a Mereo BioPharma media release, additional analyses of data from both COSMIC and ORBIT studies are ongoing, including evaluations of other bone health measures and clinical endpoints beyond fractures.
  • 29 Dec 2025 Primary endpoint has not been met (Annualized Rate of all Radiographically-confirmed Fractures, Including Morphometric Vertebral Fractures During the Active-controlled Period) , according to a Mereo BioPharma media releas

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