Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Start Date
12/12/2025
Completion Date
2/1/2029
Summary
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Detailed 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 will be evaluated.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
AGA2115
Placebo
Conditions
Locations
Phoenix Children's
Phoenix, Arizona 85016
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware 19803
United States
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
Indianapolis, Indiana 46202
United States
Washington University School of Medicine in St. Louis
St Louis, Missouri 63110
United States
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
Albuquerque, New Mexico 87160
United States
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio 43210
United States
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
Portland, Oregon 97239
United States
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
Nashville, Tennessee 37232
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 M5G 2C4
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
Oxford University Hospitals NHS Foundation Trust
Oxford,
United Kingdom