Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05549258
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-07-22
Brief Title:
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-Label Multicenter Study to Evaluate the Pharmacokinetics Pharmacodynamics and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 open-label multicenter study to evaluate the pharmacokinetics PK pharmacodynamics PD and safety of inebilizumab in eligible pediatric participants 2 to 18 years of age with recently active neuromyelitis optica spectrum disorder NMOSD who are seropositive for autoantibodies against aquaporin-4 AQP4-immunoglobulin IgG
Detailed Description:
Approximately 15 subjects to be enrolled and receive Inebilizumab administered intravenously over 28 weeks The maximum trial duration per participant is approximately 80 weeks including up to 4 week screening period 9 visits during a 28 week open-label treatment period and approximately 4 visits during a 52 week follow-up period Safety evaluations will be performed regularly throughout the course of the study
Acquired from Horizon in 2024
Acquired from Horizon in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None