Trial intelligence / Profile preview

Setrusumab Phase 2/3 study in osteogenesis imperfecta

2024-510919-29-00Phase 3Authorised

Sponsor
Ultragenyx Pharmaceutical Inc.
Start
May 2023
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
11
01

Overview

Phase 3, randomised, double-blind trial of setrusumab in osteogenesis imperfecta (OI) (4 arms), sponsored by Ultragenyx Pharmaceutical Inc. 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. Planned start May 2023; status: authorised.

02

Drugs

setrusumab
03

Conditions

osteogenesis imperfecta (OI)

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