Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05403138
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2022-05-30
Brief Title:
Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders
Sponsor:
Tianjin Medical University General Hospital
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
A Multi-center Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders NMOSD
Status:
RECRUITING
Status Verified Date:
2023-06
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:
DAWN
Brief Summary:
The objectives of this time-to-event study were to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder NMOSD who were anti-aquaporin-4 AQP4 antibody-positive NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord optic nerves and area postrema It is usually mediated by the pathogenic AQP4-IgG Antibody-secreting cells ASCs have been recognized as essential sources of AQP4-IgG CD38 is a glycoprotein that is highly expressed on ASCs Daratumumab a CD38-directed monoclonal antibody has been shown to decrease the levels of autoantibodies in lupus myasthenia gravis or autoimmune encephalitis This randomized controlled study aims to evaluate the therapeutic potential of daratumumab in NMOSD
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?:
None
Is an FDA AA801 Violation?:
None