Inebilizumab for Neuromyelitis Optica

(N-MOmentum LT Trial)

Recruiting at 29 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amgen

Must be taking: Inebilizumab

Must not be taking: Rituximab, B-cell depleting agents

Disqualifiers: Severe infection, Tuberculosis, PML, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 42 months

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how long-term treatment with inebilizumab, a medication targeting specific immune cells, affects individuals with neuromyelitis optica spectrum disorder (NMOSD). This condition causes inflammation in the nerves of the eyes and spinal cord. Researchers aim to observe the drug's impact on immune system components, such as immunoglobulins (proteins that fight infections) and B-cells (a type of white blood cell), over time and after discontinuing treatment. The trial also focuses on assessing the safety of long-term inebilizumab use. This study may suit individuals who have completed at least two years in the N-MOmentum study or are beginning inebilizumab treatment and have NMOSD. As a Phase 4 trial, this research highlights that inebilizumab is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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.

What is the safety track record for inebilizumab?

Research has shown that inebilizumab is generally well-tolerated by people with neuromyelitis optica spectrum disorder (NMOSD). In one study, urinary tract infections were the most common side effect, affecting at least 10% of patients. This indicates that while some experienced this side effect, most did not.

Long-term safety data indicate that although potential risks exist, serious infections are rare, suggesting the treatment is relatively safe over time.

Inebilizumab has received FDA approval for NMOSD, reflecting a strong safety record based on previous research. However, like any treatment, it may cause side effects, so discussing these with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Inebilizumab is unique because it specifically targets and depletes B cells, which play a crucial role in the autoimmune attacks associated with neuromyelitis optica spectrum disorder (NMOSD). Unlike standard treatments like rituximab, which also targets B cells but is used off-label, or eculizumab, which inhibits the complement system, inebilizumab directly reduces the population of B cells by targeting the CD19 antigen. Researchers are excited about inebilizumab because its targeted action could offer a more focused approach to managing NMOSD, potentially reducing the frequency and severity of attacks while minimizing side effects.

What is the effectiveness track record for inebilizumab in treating NMOSD?

Research shows that inebilizumab, the treatment under study in this trial, effectively treats neuromyelitis optica spectrum disorder (NMOSD). Studies have found that it greatly lowers the risk of NMOSD attacks, which can cause lasting disabilities. Data from the N-MOmentum trial demonstrated that long-term use of inebilizumab provides ongoing benefits for people with NMOSD. This medication targets and reduces B-cells, which are involved in the disease. Overall, inebilizumab offers significant benefits for individuals with NMOSD. ^{1 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Inebilizumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Participants with NMOSD exposed to inebilizumab Experimental Treatment 2 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

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

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

Trials

21

Recruited

2,500+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder. Nie, T., Blair, HA.[2023]

Inebilizumab effectively depletes B cells in patients with neuromyelitis optica spectrum disorders (NMOSD) with a 300 mg intravenous dose administered on Day 1 and Day 15, followed by every 6 months, demonstrating its mechanism of action against this B cell-driven disease.

The study found that variations in drug exposure levels among patients did not significantly impact clinical outcomes, such as the risk of NMOSD attacks or disability progression, indicating consistent efficacy across different patient responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic modelling and exposure-response assessment of inebilizumab in subjects with neuromyelitis optica spectrum disorders. Yan, L., Wang, B., She, D., et al.[2022]

Inebilizumab effectively induces rapid and durable depletion of B cells in adults with neuromyelitis optica spectrum disorder (NMOSD), showing significant clinical benefits over a follow-up period of at least 2.5 years.

Patients who achieved deeper B-cell depletion after the first 6 months of treatment experienced lower annual attack rates and fewer new MRI lesions, indicating that the extent of B-cell depletion is linked to improved disease stability and reduced activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bennett, JL., Aktas, O., Rees, WA., et al.[2022]

Inebilizumab is a humanized anti-CD19 monoclonal antibody that effectively targets and depletes CD19-expressing B cells, which is crucial for treating autoimmune diseases.

In June 2020, inebilizumab received its first approval in the USA for treating neuromyelitis optica spectrum disorder (NMOSD) in adults who are positive for AQP4-IgG, marking a significant milestone in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inebilizumab: First Approval. Frampton, JE.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inebilizumab in AQP4-Ab-positive neuromyelitis optica spectrum disorder. Siebert, N., Duchow, A., Paul, F., et al.[2021]

In a long-term study of 75 adults with neuromyelitis optica spectrum disorder treated with inebilizumab for over 4 years, the annualized attack rate was very low at 0.052 attacks per person per year, indicating strong efficacy in preventing attacks.

Inebilizumab was well tolerated with only 2.7% of participants experiencing serious adverse events, and no deaths reported, suggesting it is a safe treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rensel, M., Zabeti, A., Mealy, MA., et al.[2022]

Citations

1. uplizna.com uplizna.com/nmosd/about-uplizna/results

NMOSD Results & Attack Reduction In the study, UPLIZNA proved to be an effective treatment to reduce the risk of NMOSD attacks that can lead to permanent disabilities.

2. upliznahcp.com upliznahcp.com/nmosd/mechanism-of-action/efficacy-nmosd-treatment

Efficacy in NMOSD Treatment Efficacy data is provided in patients treated for NMOSD with UPLIZNA® (inebilizumab-cdon). See safety info.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38760098/

end-of-study results from the open-label period of the N- ... Interpretation: Data from the end-of-study analysis of the N-MOmentum trial showed continued and sustained clinical benefits of long-term inebilizumab treatment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02200770

NCT02200770 | N-MOmentum: A Clinical Research Study ... The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD. This is ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442224000772

Safety and efficacy of inebilizumab for the treatment ... Data from the end-of-study analysis of the N-MOmentum trial showed continued and sustained clinical benefits of long-term inebilizumab treatment in individuals ...

6. upliznahcp.com upliznahcp.com/nmosd/mechanism-of-action/safety-adverse-events

Safety and Side Effects | UPLIZNA® (inebilizumab-cdon) ... The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02200770

Study Details | NCT02200770 | N-MOmentum: A ... The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD.

8. uplizna.com uplizna.com/nmosd

NMOSD Treatment *77% relative reduction in attacks; in a clinical study, 11% of 161 patients on UPLIZNA had an attack through the first 28 weeks of treatment vs 42% of 52 ...

9. neurology.org neurology.org/doi/10.1212/WNL.96.15_supplement.2283

Long Term Safety Outcomes with Inebilizumab Treatment ... Owing to the expected volume of EoS data, only safety data will be presented here, including TEAE/TESAE profiles, severe and opportunistic infections, IRRs, ...