Ultragenyx-led ORBIT Study


Ultragenyx, in partnership with Mereo, are leading the Orbit clinical study, which is for individuals living with osteogenesis imperfecta (OI) Types I, III and IV. The purpose of this study is to investigate the efficacy and safety of setrusumab, a monoclonal antibody, for the potential treatment of OI in pediatric and young adult patients. The study aims to understand the potential reduction in fractures as well as other impacts of OI.

This study is now closed to recruitment.

You can find the press release published on the 30th April 2024  here

The interim phase 2 data which was published in Oct 23 can be read here.

Study participants had to be at least 5 but not yet 26 years of age, have a confirmed diagnosis of OI Types I, III, or IV, and willing not to receive bisphosphonate therapy during the study.

For more information, please see clinicaltrials.gov or reach out to trialrecruitment@ultragenyx.com  or OIStudyInfo@ultragenyx.com

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