This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).
This Phase 2 study will evaluate the safety and efficacy of AGA2115 in three different dosing regimens in Chinese adults and adolescents with Type I, III, or IV OI. Participants will be in the study for 24 or 27 months depending on their assigned cohort. During the first 12 months of the study, adult and adolescent participants will be randomized separately in a 1:1:1:1 ratio to one of three AGA2115 dosing regimens or control cohort. During months 12 to 24 or 27, all participants will receive AGA2115 and attend visits for the evaluation of safety and efficacy parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Participants will receive AGA2115 administered by subcutaneous injection
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to Month 27 (Cohorts 1 and 5); Baseline to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8)
Percent change from Baseline at Month 3, 6, 9 and 12 in Bone Mineral Density (BMD) at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adults and adolescents.
Time frame: Months 3, 6, 9, and 12
Change from Baseline at Month 3, 6, 9, and 12 in BMD Z-score at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adolescents.
Time frame: Month 3, 6, 9, and 12
Percent Change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in bone turnover markers CTX-1 and P1NP
Time frame: Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures between Baseline and Month 12
Time frame: Baseline to Month 12
Annualized fracture rate for incident fractures occurring between Baseline and Month 12
Time frame: Baseline to Month 12
AGA2115 observed concentration for the treatment groups
Time frame: Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).
Serum anti-AGA2115 antibodies
Time frame: Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).
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