Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-16
Brief Title:
FcRn Antagonists Efgartigimod for Acute NMOSD Attack
Sponsor:
Tianjin Medical University General Hospital
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
FcRn Antagonists Efgartigimod for Acute Neuromyelitis Optica Spectrum Disorders NMOSD Attack a Phase 2 Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
FACT
Brief Summary:
NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves The objectives of this study are to assess the efficacy and safety of FcRn antagonists efgartigmod for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 AQP4 antibody-positive The potential of efgartigimod an IgG1 Fc fragment that competes with IgG for FcRn binding thereby lowering IgG levels warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None