Clinical Trials in France / NCT07062588
Recruiting
Phase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
NCT07062588 · tracked via the Priya Life Science France tracker
Condition(s) studied
Osteogenesis Imperfecta (OI)
Investigational drug(s) / intervention(s)
AGA2115 →Placebo
AGA2115: Subcutaneous injection
Placebo: Subcutaneous injection
Study summary
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Eligibility
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 affect bone metabolism such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders
* Current hyper- or hypocalcemia
* History of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
* Treatment with bisphosphonates within the past 6 months
* Treatment with teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months
* Treatment with denosumab (or denosumab biosimilars) within the past 2 years
* Treatment with anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time
* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months
* Malignancy within the last 5 years
* Pregnant or breastfeeding women, or women planning to become pregnant during the study
* Participation in any clinical study within the past 12 months during which the participant was administered any IP (participant must also agree not to enroll in any other clinical study concurrently in which IP is administered)
Primary outcome measure(s)
- Percent change from Baseline at Month 12 in lumbar spine BMD — 12 months
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's | Phoenix | Arizona | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | Recruiting |
| Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology | Indianapolis | Indiana | Recruiting |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | Not Yet Recruiting |
| New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC) | Albuquerque | New Mexico | Recruiting |
| The Ohio State University Wexner Medical Center (OSUWMC) | Columbus | Ohio | Not Yet Recruiting |
| Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic | Portland | Oregon | Recruiting |
| Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic | Nashville | Tennessee | Not Yet Recruiting |
| Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro | Buenos Aires | Argentina | Recruiting |
| Monash University-Monash Medical Centre (MMC) | Melbourne | Australia | Recruiting |
| Royal Melbourne Hospital | Parkville | Australia | Recruiting |
| Royal North Shore Hospital (RNSH) | Saint Leonards | Australia | Recruiting |
| Adults Westmead Hospital | Westmead | Australia | Not Yet Recruiting |
| University Health Network - Toronto General Hospital - Osteoporosis Clinic | Toronto | Ontario | Recruiting |
| Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade | Aarhus | Denmark | Not Yet Recruiting |
| Odense Universitetshospital | Odense | Denmark | Not Yet Recruiting |
| Hopital Edouard Herriot | Lyon | France | Not Yet Recruiting |
| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere | Paris | France | Not Yet Recruiting |
| Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit | Leiden | Netherlands | Not Yet Recruiting |
| Erasmus MC | Rotterdam | Netherlands | Not Yet Recruiting |
| Isala ziekenhuizen | Zwolle | Netherlands | Not Yet Recruiting |
| Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital | Cambridge | United Kingdom | Not Yet Recruiting |
| Lothian Health Board, Western General Hospital | Edinburgh | United Kingdom | Recruiting |
| Royal National Orthopaedic Hospital NHS Trust | London | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom | Not Yet Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07062588 on ClinicalTrials.gov ↗ ← All trials in France