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Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-12-12
Completion Date
2029-02
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
AGA2115
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (26)
Phoenix Children's
Phoenix, Arizona, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
Indianapolis, Indiana, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center (UNMC) - Diabetes and Endocrinology Center
Omaha, Nebraska, United States
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
Albuquerque, New Mexico, United States
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, United States
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
Portland, Oregon, United States
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
Nashville, Tennessee, United States
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
Buenos Aires, Argentina
Monash University-Monash Medical Centre (MMC)
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia
Royal North Shore Hospital (RNSH)
Saint Leonards, Australia
Adults Westmead Hospital
Westmead, Australia
University Health Network - Toronto General Hospital - Osteoporosis Clinic
Toronto, Ontario, Canada
Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
Aarhus, Denmark
Odense Universitetshospital
Odense, Denmark
Hopital Edouard Herriot
Lyon, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris, France
Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit
Leiden, Netherlands
Erasmus MC
Rotterdam, Netherlands
Isala ziekenhuizen
Zwolle, Netherlands
Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
Cambridge, United Kingdom
Lothian Health Board, Western General Hospital
Edinburgh, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
London, United Kingdom