Inebilizumab for Neuromyelitis Optica
(N-MOmentum LT Trial)
Trial Summary
What is the purpose of this trial?
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
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is inebilizumab safe for humans?
Inebilizumab, also known as Uplizna, has been generally well tolerated in clinical trials for neuromyelitis optica spectrum disorder (NMOSD), with common side effects including urinary tract infections and joint pain. It has been used safely in humans for over four years in studies, with the most frequent side effects being infusion reactions and respiratory infections.12345
How does the drug inebilizumab work for neuromyelitis optica?
Inebilizumab is unique because it targets and depletes B cells that express a specific marker called CD19, which helps reduce attacks in neuromyelitis optica. It is given as an intravenous infusion and has been shown to lower the risk of attacks and hospitalizations in patients with this condition.12467
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
This trial is for adults over 18 with Neuromyelitis Optica Spectrum Disorders who have been treated with inebilizumab for at least two years or are starting treatment. Participants must use effective contraception and give informed consent.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive long-term treatment with inebilizumab to monitor safety and effects on immunoglobulins and B-cell counts
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation, focusing on repletion of immunoglobulins and B-cell counts
Treatment Details
Interventions
- Inebilizumab
Inebilizumab is already approved in United States, European Union, Canada for the following indications:
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Horizon Therapeutics Ireland DAC
Lead Sponsor