Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Setrusumab in Pediatric Japanese Subjects with Osteogenesis Imperfecta
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase 3 Study of Setrusumab in Pediatric Japanese Subjects with Osteogenesis Imperfecta Type I III or IV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate including morphometric vertebral fractures
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Extension Period All participants will receive setrusumab until it becomes commercially available in Japan consent is withdrawn or the study is otherwise discontinued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None