Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) — N-MOmentum LT  

Neuromyelitis Optica Spectrum Disorder Clinical Trial

Official title: A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

• NCT number: NCT06180278
• Study type: Interventional
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo@amgen.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2, 2024
• Completion date: June 30, 2028