Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

November 15, 2017

Primary Completion Date

July 4, 2022

Study Completion Date

July 4, 2022

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

Fresolimumab

The purpose of this study is to determine if fresolimumab is safe as a treatment for OI. We will evaluate the safety of a single dose of fresolimumab in the 1st stage of the study. We will evaluate the safety of multiple doses of fresolimumab in the 2nd stage of the study. The Investigators will evaluate the effect of the two doses of fresolimumab in Stage 1 on markers of bone turnover and determine the dose that shows the greatest reduction in bone turnover markers compared to no treatment. This dose will be chosen for the repeat dose studies. If there were no significant changes between the bone turnover markers with either dose, the 4 mg/kg dose will be chosen for the repeat dose study.

Trial Locations (2)

77030

Baylor College of Medicine, Houston

97239

Oregon Health Science University, Portland

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

collaborator

Oregon Health and Science University

OTHER

lead

Baylor College of Medicine

OTHER

NCT03064074 - Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta | Biotech Hunter | Biotech Hunter