A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Inclusion Criteria:

• Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing
• One or more fractures in the past 5 years
• Capable of giving signed consent

Exclusion Criteria:

• History of skeletal malignancies or other bone diseases (other than OI)
• History of neural foraminal stenosis (except if due to scoliosis)
• History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack
• History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
• Treatment with bisphosphonates within 3 months of randomisation
• Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation