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

Study acronym: N-MOmentum LT
StatusActive, Not Recruiting
PhasePhase 4
SponsorAmgen
Started2024-04-02
View on ClinicalTrials.gov ↗
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

Amendment record

Amended 15 times since 2023-12-20; most recent filed 2025-11-19. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-11-19
Amendment Study Status, Contacts/Locations v15
2025-07-22
Amendment RecruitingActive, Not Recruiting Study Status, Study Design, Contacts/Locations v14
2025-05-21
Amendment Study Status, Contacts/Locations v13
2025-05-13
Amendment Study Status, Contacts/Locations v12
2025-04-23
Amendment Study Status, Contacts/Locations v11
2025-04-16
Amendment Study Status, Contacts/Locations v10
2025-04-02
Amendment Study Status, Contacts/Locations v9
2025-03-14
Amendment Study Status, Contacts/Locations v8
2024-10-30
Amendment Study Status, Contacts/Locations v7
2024-10-15
Amendment Study Status, Contacts/Locations v6
2024-10-04
Amendment Study Status, Contacts/Locations v5
2024-05-10
Amendment Study Status, Contacts/Locations, References v4
2024-04-26
Amendment Study Identification, Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations, IPDSharing v3
2024-04-24
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2024-02-14
Amendment Study Status, Eligibility v1
2023-12-20
Original filing
Trial Details
NCT Number NCT06180278
Lead Sponsor Amgen
Conditions Neuromyelitis Optica Spectrum Disorder
Enrollment 32 participants
Start Date 2024-04-02
Primary Completion 2028-06-26 (estimated)
Study Completion 2028-06-26 (estimated)
Updated on ClinicalTrials.gov 2025-11-21