clinical trial · NCT06636071
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfectasetrusumab
brief summary
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate, including morphometric vertebral fractures.
started
Oct 25, 2024
primary completion
Jan 1, 2027
completion
Jan 1, 2028
last updated
Mar 13, 2026
detailed description
This study will be conducted in Japan only and consists of a screening period, an open-label treatment period, and an open-label extension period. Participants will receive setrusumab for up to 24 months during the open-label Treatment Period followed by continued setrusumab treatment during the open-label Extension Period. All participants will receive setrusumab until it becomes commercially available in Japan, consent is withdrawn, or the study is otherwise discontinued.
official title
An Open-label Phase 3 Study of Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta Type I, III, or IV
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol