11
Participants
Start Date
November 15, 2017
Primary Completion Date
July 4, 2022
Study Completion Date
July 4, 2022
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.
Baylor College of Medicine, Houston
Oregon Health Science University, Portland
Genzyme, a Sanofi Company
INDUSTRY
Oregon Health and Science University
OTHER
Baylor College of Medicine
OTHER