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Study on Imlifidase for Treating Acute Inflammation in Patients with Neuromyelitis Optica Spectrum Disorder

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What is this study about?

This clinical trial is focused on studying a condition known as Neuromyelitis Optica Spectrum Disorder (NMOSD), which is sometimes referred to as Devic disease. This is a rare autoimmune disease that primarily affects the optic nerves and spinal cord, leading to symptoms such as vision loss and muscle weakness. The trial will investigate the effects of a treatment called Imlifidase, which is administered as a solution through an intravenous infusion. Imlifidase is designed to target and reduce specific antibodies in the blood that are believed to contribute to the inflammation seen in NMOSD.

The purpose of the study is to evaluate how effective Imlifidase is in reducing these harmful antibodies in patients experiencing severe symptoms of NMOSD, such as optic neuritis (inflammation of the optic nerve) and myelitis (inflammation of the spinal cord). Participants in the study will receive the treatment and will be monitored to see if the levels of these antibodies decrease within six hours after receiving Imlifidase. Some participants may receive a placebo instead of the actual treatment to help compare the effects.

Throughout the study, participants will be closely observed to assess the impact of the treatment on their condition. The trial aims to provide valuable insights into whether Imlifidase can effectively manage acute inflammation in NMOSD, potentially offering a new therapeutic option for those affected by this challenging disease.

1 joining the study

Upon joining the study, the participant must provide a signed informed consent. This indicates understanding and agreement to participate in the trial.

The participant must be willing and able to follow the study protocol.

2 eligibility confirmation

The participant must be at least 18 years old and have a diagnosis of neuromyelitis optica spectrum disorder (NMOSD) according to specific criteria.

A positive test for anti-AQP4 lgG antibodies is required, either at the time of joining or in the medical history.

The participant must have experienced a recent onset of symptoms, such as weakness or loss of visual acuity, within 14 days prior to treatment.

3 treatment administration

The participant will receive a treatment with imlifidase, administered as an intravenous infusion. The product used is called Idefirix 11 mg powder for concentrate for solution for infusion.

The goal is to reduce the levels of specific antibodies in the blood within 6 hours after treatment.

4 monitoring and follow-up

The participant’s response to the treatment will be monitored, focusing on the reduction of specific antibodies in the blood.

The primary endpoint is the proportion of participants achieving a reduction in antibody levels below detection limits within 6 hours after treatment.

5 completion of the study

The study is expected to conclude by December 1, 2025.

Participants will be monitored throughout the study duration to assess the effectiveness and safety of the treatment.

Who Can Join the Study?

  • The patient must have signed an informed consent form before any study-related procedures begin. This means they agree to participate after understanding the study details.
  • The patient must be willing and able to follow the study’s rules and procedures.
  • The patient must be at least 18 years old at the time of screening.
  • The patient must have been diagnosed with neuromyelitis optica spectrum disorder (NMOSD), also known as Devic disease, according to specific criteria. They must have a positive test for anti-AQP4 IgG antibodies, which are proteins in the blood related to the condition.
  • The patient must have experienced a worsening of symptoms, such as weakness or loss of vision, due to NMOSD within the last 14 days before receiving the study treatment.
  • If the patient has worsening myelitis (inflammation of the spinal cord), it must cause a noticeable increase in difficulty moving and require help to walk. If they have worsening optic neuritis (inflammation of the eye nerve), it must cause a noticeable decrease in vision, with vision ranging from 20/60 to 20/99 or worse.
  • The patient must need immediate treatment with steroids, which are medications that reduce inflammation.
  • The patient can be newly diagnosed or already receiving ongoing treatments like azathioprine, mycophenolate mofetil, or rituximab, or they may not be on any maintenance treatment.
  • The patient must test negative for infections like hepatitis B, hepatitis C, and HIV.
  • Women who can have children must agree to use a highly effective birth control method from the day of treatment until at least 6 months after receiving the study medication, unless they are not sexually active.
  • Men must agree to use two forms of birth control from the day of treatment until at least 2 months after receiving the study medication, unless they are not sexually active.

Who Cannot Join the Study?

  • Individuals who do not have a diagnosis of neuromyelitis optica spectrum disorder (also known as Devic disease) cannot participate. This is a condition that affects the eyes and spinal cord.
  • Participants must be within a specific age range, which is not specified here, but generally means that very young children or older adults might not be eligible.
  • Both males and females can participate, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population, such as those unable to give consent or those with certain disabilities, are not eligible.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Eihsobm Uzvpulkgwzsj Mguqnop Celivfe Rbrvtelsh (rvvjphz Mfc Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.12.2023

Trial locations

Investigated drugs:

Imlifidase is a medication being studied for its ability to reduce inflammation in patients with a condition called neuromyelitis optica spectrum disorder (NMOSD). This condition is associated with the presence of harmful antibodies in the body. The trial aims to see if imlifidase can lower the levels of these antibodies to undetectable levels within 6 hours of treatment. This could potentially help in managing severe symptoms like optic neuritis and myelitis, which are common in NMOSD.

Investigated diseases:

Neuromyelitis Optica Spectrum Disorder – This is a rare autoimmune disease that primarily affects the optic nerves and spinal cord. It leads to inflammation and damage in these areas, causing symptoms such as vision loss, weakness, and paralysis. The disease can progress with episodes of attacks, which may result in further neurological damage. These attacks can vary in frequency and severity, potentially leading to cumulative disability over time. The condition is associated with the presence of specific antibodies, such as anti-AQP4 IgG, which target and damage the body’s own cells.

Trial ID:
2024-517176-38-00
Protocol code:
NL80681.078.22
Trial Phase:
Therapeutic exploratory (Phase II)

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