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
Latest Information Update: 19 May 2025
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.