30 Participants Needed

Inebilizumab for Neuromyelitis Optica

(N-MOmentum LT Trial)

Recruiting at 21 trial locations
MM
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Amgen
Must be taking: Inebilizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

M

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

I am over 18 and can sign the consent form.
I am using, and will continue to use, effective birth control for 6 months after treatment.
I have been part of the N-MOmentum study for 2 years or am starting inebilizumab treatment.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive long-term treatment with inebilizumab to monitor safety and effects on immunoglobulins and B-cell counts

42 months
Regular visits for blood sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation, focusing on repletion of immunoglobulins and B-cell counts

6 months

Treatment Details

Interventions

  • Inebilizumab
Trial OverviewThe study tests the long-term safety of inebilizumab, monitoring its effects on immune system components like B-cells and immunoglobulins during and after treatment in NMOSD patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants with NMOSD exposed to inebilizumabExperimental Treatment2 Interventions
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 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.

Inebilizumab is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Uplizna for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
🇪🇺
Approved in European Union as Uplizna for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
🇨🇦
Approved in Canada as Uplizna for:
  • 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

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

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

Trials
21
Recruited
2,500+

Findings from Research

Inebilizumab-cdon (Uplizna™) is an FDA-approved treatment for neuromyelitis optica spectrum disorder (NMOSD), demonstrating a safe and effective profile in clinical trials.
The drug works by depleting CD19+ B cells through mechanisms like antibody-dependent cell cytotoxicity (ADCC) and phagocytosis, which are crucial for its therapeutic action.
Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder).Ali, F., Sharma, K., Anjum, V., et al.[2022]
Inebilizumab is an effective monoclonal antibody treatment for adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 antibodies, significantly reducing the risk of NMOSD attacks and disability worsening over a period of at least 4 years.
The treatment was generally well tolerated, with common side effects including urinary tract infections and joint pain, indicating a favorable safety profile for patients.
Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder.Nie, T., Blair, HA.[2023]
Inebilizumab, a monoclonal antibody that targets CD19 on B cells, has been approved for treating aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorders (NMOSD) and has shown significant efficacy in prolonging the time to relapse in patients compared to placebo in the N-MOmentum study.
The treatment involves initial intravenous doses of 300 mg every 2 weeks, followed by maintenance infusions every 6 months, with common side effects including infusion reactions and infections, indicating a manageable safety profile.
Inebilizumab in AQP4-Ab-positive neuromyelitis optica spectrum disorder.Siebert, N., Duchow, A., Paul, F., et al.[2021]

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder). [2022]
Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder. [2023]
Inebilizumab in AQP4-Ab-positive neuromyelitis optica spectrum disorder. [2021]
Inebilizumab: First Approval. [2021]
Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial. [2022]
Pharmacodynamic modelling and exposure-response assessment of inebilizumab in subjects with neuromyelitis optica spectrum disorders. [2022]
Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial. [2022]