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

NCT06180278 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-21

No results posted yet for this study

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

Conditions

Interventions

OTHER

Blood tests

Participants will have blood tests done at each scheduled visit (approximately every 6 months).

DRUG

Inebilizumab

Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment at the discretion of their treating physician will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2028-06-26
Completion
2028-06-26
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • Hungary
  • Poland
  • South Korea
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180278 on ClinicalTrials.gov