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 I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV Osteogenesis Imperfecta Brittle Bone Disease BPS804 BPS804 Dose 1 BPS804 Dose 2 BPS804 Dose 3 BPS804 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 Site currently not accepting new patients, but might later
    San Francisco California 94143 United States
  • Mereo Investigator Site accepting new patients
    Portland Oregon 97239 United 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