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Trial intelligence / Profile preview
Setrusumab in osteogenesis imperfecta
NL-OMON59648Phase 3Active, not recruiting
- Sponsor
- Ultragenyx Pharmaceutical Inc.
- Start
- Jun 2023
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in osteogenesis imperfecta (OI) comparing Setrusumab with Placebo (2 arms). Primary endpoints: Percent change in serum P1NP from baseline at Month 1 and Annualized rate of radiographically confirmed fractures excluding morphometric vertebral fractures and fractures of the fingers, toes, face, and skull. Started Jun 2023; status: active, not recruiting.
02
Drugs
setrusumab
03
Conditions
osteogenesis imperfecta (OI)
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