Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180278
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-11-17
Brief Title:
Long-term Open-label Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder NMOSD
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Long-term Open-label Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD N-MOmentum LT
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:
N-MOmentum LT
Brief Summary:
The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins B-cell counts and other safety measures and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment The objectives include
1 To establish the nadir in circulating immunoglobulins Ig during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment
2 To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin Ig levels
3 To assess long-term safety of inebilizumab
4 To assess other long-term effects of inebilizumab
1 To establish the nadir in circulating immunoglobulins Ig during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment
2 To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin Ig levels
3 To assess long-term safety of inebilizumab
4 To assess other long-term effects of inebilizumab
Detailed Description:
This study aims to enroll 30 participants who either participated in the open-label period OLP of the N-MOmentum study CD-IA-MEDI-551-1155 NCT02200770 a global registrational study that determined the safety and efficacy of inebilizumab for treatment of NMOSD or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites
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?:
False
Is an FDA AA801 Violation?:
None