Trial Profile
An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta
Status:
Recruiting
Phase of Trial:
Phase II/III
Latest Information Update: 29 Mar 2024
Price :
$35
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At a glance
- Drugs Setrusumab (Primary) ; Bisphosphonates
- Indications Osteogenesis imperfecta
- Focus Registrational; Therapeutic Use
- Acronyms Orbit
- Sponsors Ultragenyx Pharmaceutical
- 27 Mar 2024 According to an Ultragenyx Pharmaceutical media release, additional data from the Phase 2 portion of the Orbit study are expected in the second half of 2024.
- 07 Jan 2024 According to an Ultragenyx Pharmaceutical media release, longer-term phase 2 data from this study are expected in 2024.
- 07 Jan 2024 According to an Ultragenyx Pharmaceutical media release, phase 3 portion of Orbit study expected to be fully enrolled around the end of the first quarter of 2024.