NCT03118570

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Osteogenesis Imperfecta, Type I
• Osteogenesis Imperfecta Type III
• Osteogenesis Imperfecta Type IV

Interventions

Type	Name	Description
DRUG	setrusumab	Intravenous infusion
DIETARY_SUPPLEMENT	Calcium	tablets
DIETARY_SUPPLEMENT	Vitamin D	capsules
DRUG	zoledronic acid (optional)	Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.

Timeline

• Start date: 2017-09-11
• Primary completion: 2019-10-01
• Completion: 2020-11-12
• First posted: 2017-04-18
• Last updated: 2023-07-05
• Results posted: 2022-03-02

Locations

25 sites across 5 countries: United States, Canada, Denmark, France, United Kingdom

Regulatory

• FDA-regulated drug study