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Osteogenesis Imperfecta Trial of AGA2115 for ADUlts with COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
EU CTIS ID: 2025-522951-24-00
What this study is testing
To determine the effect of AGA2115 on BMD at the lumbar spine at Month 12
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Vitamin D deficiency
- 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)
- 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
See the full eligibility 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
- Vitamin D deficiency
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Argentina
- United States
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Argentina; United States; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.