A Phase 2 Multi-center, Randomized, Open-Label, Dose Regimen-Finding Study of AGA2115 in Chinese Adults and Adolescents With Type I, III, or IV Osteogenesis Imperfecta
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:
• Adults (18-75 years) or adolescents (12-17 years) with a confirmed diagnosis of Osteogenesis Imperfecta (OI) Type I, III, or IV with genetic confirmation of pathogenic variants in COL1A1 or COL1A2 genes
• BMD T-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adults) or BMD Z-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adolescents)
• 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
Locations
Other Locations
China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
RECRUITING
Beijing
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING
Shanghai
The University of Hong Kong-Shenzhen Hospital
RECRUITING
Shenzhen
Children's Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Contact Information
Primary
Yolanda Liu
yolanda.liu@angitiabio.com
+86 13911537795
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2029-07
Participants
Target number of participants: 48
Treatments
Experimental: Cohort 1
Adult participants will receive AGA2115 Dose Regimen 1.
Experimental: Cohort 2
Adult participants will receive AGA2115 Dose Regimen 2.
Experimental: Cohort 3
Adult participants will receive AGA2115 Dose Regimen 3.
No_intervention: Cohort 4
Adult participants will only receive AGA2115 Dose Regimen 2 in the second year.
Experimental: Cohort 5
Adolescent participants will receive AGA2115 Dose Regimen 1.
Experimental: Cohort 6
Adolescent participants will receive AGA2115 Dose Regimen 2.
Experimental: Cohort 7
Adolescent participants will receive AGA2115 Dose Regimen 3.
No_intervention: Cohort 8
Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year.
Related Therapeutic Areas
Sponsors
Leads: Angitia Biopharmaceuticals Guangzhou Limited