Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05346354
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-04-20
Brief Title:
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 23 Open-label Historical-controlled Single-arm Multicenter Study to Evaluate the Efficacy Pharmacokinetics Pharmacodynamics and Safety of Ravulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive AQP4-Ab Neuromyelitis Optica Spectrum Disorder NMOSD
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder NMOSD
Detailed Description:
None
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