Summary

for people ages 18 years and up (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 comparing it with a dummy treatment and measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 1 year.

Official Title

A Phase 2b Study, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With 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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 24 months
  • Capable of giving signed consent

You CAN'T join if...

  • History of skeletal malignancies or other bone diseases (other than OI)
  • 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
  • Mereo Investigator Site accepting new patients
    Albuquerque New Mexico 87106 United States
  • Mereo Investigator Site accepting new patients
    Houston Texas 77030 United States
  • Mereo Investigator Site accepting new patients
    Saint Paul Minnesota 55101 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mereo BioPharma
Links
Study Website
ID
NCT03118570
Phase
Phase 2
Lead Scientist
Andrew Burghardt
Study Type
Interventional
Last Updated
February 2, 2018