BridgeMD
New treatment option for Osteogenesis Imperfecta (OI)
Official title Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
ClinicalTrials.gov ID: NCT07062588
What this study is testing
What is AGA2115?
AGA2115 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for osteogenesis imperfecta (oi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 27 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
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...
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck
You likely can't join if
- Vitamin D deficiency
- Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, abnormal...
- 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
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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 6 more site(s).
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 study runs about 27 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 20 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.