A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)
Angitia Incorporated Limited
Summary
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Description
This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters w…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol * BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck Exclusion Criteria: * Vitamin D deficiency * Concomitant uncontrolled diseases or conditions that could affec…
Interventions
- DrugAGA2115
Subcutaneous injection
- OtherPlacebo
Subcutaneous injection
Locations (27)
- Phoenix Children'sPhoenix, Arizona
- Yale University School of MedicineNew Haven, Connecticut
- Nemours/Alfred I. duPont Hospital for ChildrenWilmington, Delaware
- Indiana University School of Medicine, Department of Medicine and Pediatrics Division of EndocrinologyIndianapolis, Indiana
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- University of Nebraska Medical Center (UNMC) - Diabetes and Endocrinology CenterOmaha, Nebraska