Last updated 49 days ago

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

80 patients around the world

Available in Argentina, United States

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.

Angitia Incorporated Limited

1Research sites

80Patients around the world

This study is for people with

Rare diseases

Imperfect osteogenesis

Requirements for the patient

To 75 Years

All Gender

Medical requirements

: 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.
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).

Sites

IDIM - Sede Centro - CABA

Libertad 836, C1012AAR Cdad. Autónoma de Buenos Aires, Argentina

StudyIDUN

SponsorAngitia Incorporated Limited

Study typeInterventional

Conditions

Imperfect osteogenesis

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07062588