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Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)

RecruitingPhase 2

Sponsor: Angitia Incorporated Limited

Conditions: Osteogenesis Imperfecta (OI)

Interventions: AGA2115, Placebo

Countries: United States, Argentina, Australia, Canada, Denmark, France, Netherlands, United Kingdom

This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (26)

Phoenix, Arizona, United States
New Haven, Connecticut, United States
Wilmington, Delaware, United States
Indianapolis, Indiana, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Buenos Aires, Argentina
Melbourne, Australia
Parkville, Australia
Saint Leonards, Australia
Westmead, Australia
Toronto, Ontario, Canada
Aarhus, Denmark
Odense, Denmark
Lyon, France
Paris, France
Leiden, Netherlands
Rotterdam, Netherlands
Zwolle, Netherlands
Cambridge, United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
Oxford, United Kingdom