Summary

for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Andrew Burghardt

Description

Summary

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.

Official Title

Protocol Title: 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).

Keywords

Osteogenesis Imperfecta, Type IOsteogenesis Imperfecta Type IIIOsteogenesis Imperfecta Type IVOsteogenesis ImperfectaBrittle Bone DiseaseBPS804BPS804 Dose 1BPS804 Dose 2BPS804 Dose 3BPS804 Dose 4

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation

Locations

  • Mereo Investigator Sitecurrently not accepting new patients, but might later
    San FranciscoCalifornia94143United States
  • Mereo Investigator Siteaccepting new patients
    PortlandOregon97239United States

Lead Scientist

  • Andrew Burghardt
    Andrew Burghardt is a Research Specialist in the Department of Radiology and Biomedical Imaging at University of California, San Francisco where he serves as the Technical Director of the Quantitative Micro-Imaging Facility (QMIF). His area of expertise is high-resolution imaging computational analysis of musculoskeletal tissues.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mereo BioPharma
Links
Study Website
ID
NCT03118570
Phase
Phase 2
Study Type
Interventional
Last Updated