Osteogenesis Imperfecta Treatment With BPS804 – Phase IV

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

Protocol Description

The purpose of this multi-center study is to determine the best dose of the investigational drug, BPS804 to treat osteogenesis imperfecta, also known as “brittle bone disease.” This will be done by measuring the effects on bones of different doses of BPS804 compared to receiving no drug (placebo).

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, the study accepts pediatric candidates ages 18 and older, who have osteogenesis imperfecta Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, and who have had one or more fractures in the past 24 months.
Males and Females: 18 years and older

Requirements

Following a screening period that will last no more than 28 days for test results, participants will be randomly assigned to receive one of three doses of BPS804 or a placebo. Dosages will be provided intravenously during visits once a month for 12 months. During certain study visits, participants will receive physical examinations and various other tests, such as electrocardiograms, bone scans and hearing exams. When treatment with the study medicine stops, participants will have an end-of-treatment visit and one additional follow-up visit.
Visits: 17
Duration: About 15 months

Status: Open to Enrollment

Source(s) of Support

Mereo BioPharma

Primary Investigator

Gerard Vockley, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Danielle Black, BS
412-692-6893