Study on the Effects and Safety of Inebilizumab for Patients with Anti-NMDA Receptor Encephalitis

2 1 1

What is this study about?

This clinical trial is focused on studying a condition called anti-NMDA receptor encephalitis, which is a type of brain inflammation caused by the immune system attacking certain brain receptors. The study aims to evaluate the effectiveness and safety of a treatment called inebilizumab. Inebilizumab is an investigational medication, meaning it is still being studied and is not yet approved for general use. Participants in the study will receive either inebilizumab or a placebo, in addition to standard care, to see how well the treatment works compared to no active treatment.

During the study, participants will be monitored over a period of several weeks. The main goal is to assess any changes in the level of disability caused by the disease, using a scale called the mRS scale, which measures the degree of disability or dependence in daily activities. The study will also look at the safety of inebilizumab by tracking any side effects that occur during the treatment period. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein.

In addition to inebilizumab, some participants may receive other medications as part of their standard care. These include methylprednisolone, a corticosteroid used to reduce inflammation, and human normal immunoglobulin (IVIg), which is a blood-derived product used to support the immune system. Other medications like cyclophosphamide, cetirizine, and paracetamol may also be used as needed for specific purposes such as rescue therapy, premedication, or to manage symptoms like fever. The study will help determine the best approach to treating anti-NMDA receptor encephalitis and improve understanding of the disease.

1 randomization and initial treatment

Upon joining the study, the participant is randomly assigned to receive either inebilizumab or a placebo. Both groups receive standard care.

The participant must have already received at least three days of methylprednisolone 1000 mg intravenously within 30 days prior to this step. Additionally, the participant must have received either intravenous immunoglobulin (IVIg) at a dose range between 1.2 and 2 g/kg or undergone plasma exchange or plasmapheresis with a minimum of five treatments.

2 treatment administration

The participant receives the assigned treatment intravenously. The specific medication administered is either inebilizumab or a placebo, which is a saline solution without active substances.

The treatment is administered according to the study protocol, which includes regular monitoring and assessments to ensure safety and effectiveness.

3 monitoring and assessments

Throughout the study, the participant undergoes regular assessments to monitor changes in disability using the modified Rankin Scale (mRS) and other health indicators.

Safety is evaluated by tracking any adverse events or serious adverse events that occur from the start of the treatment until 24 weeks.

4 follow-up and evaluation

At 16 weeks, the primary endpoint is assessed by measuring the change in the mRS score to determine the treatment’s impact on disability.

Secondary endpoints include evaluating the time to achieve an mRS score of 2 or less, cognitive outcomes, and overall survival, among other measures.

5 completion of study participation

The participant completes the study after 24 weeks of follow-up, during which all necessary data and health outcomes are collected and analyzed.

The study aims to provide insights into the safety and effectiveness of inebilizumab in treating anti-NMDA receptor encephalitis.

Who Can Join the Study?

Must have a diagnosis of NMDAR encephalitis, which is a condition where the body’s immune system attacks the brain, causing changes in mental status. This diagnosis should be confirmed by a specific test showing the presence of certain antibodies in the fluid around the brain and spinal cord.
Must be willing to stop using other treatments that affect the immune system for NMDAR encephalitis during the study.
Must have a score of 3 or higher on the mRS scale, which means having at least moderate disability. The mRS scale is a way to measure how much a disease affects daily activities.
Must have received at least 3 days of a high dose of a steroid called methylprednisolone or a similar medication within 30 days before starting the study. Additionally, must have received either a treatment called IVIg (a type of therapy using antibodies) or a procedure called plasma exchange or plasmapheresis (a process that removes certain substances from the blood) with at least 5 sessions.
Must be between the ages of 18 and 65 years old.
Both males and females can participate.

Who Cannot Join the Study?

Patients who have a different condition than anti-N-methyl-D-aspartate receptor encephalitis (also known as anti-NMDAR encephalitis) cannot participate. This is a specific type of brain inflammation.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Patients who are not able to follow the study procedures or who have other health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of certain medical conditions or treatments that could affect the study results cannot participate.
Patients who are unable to give informed consent, which means they cannot understand the study and agree to participate, cannot be included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Eukxcdg Uxxmvdnxxzwy Mfjsffa Cgaqphj Rxkrplfqr (aeqdnbi Meo	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2023
The Netherlands	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Inebilizumab is a medication being studied for its potential to help patients with anti-NMDA receptor encephalitis. This condition is a type of brain inflammation that can cause various neurological symptoms. Inebilizumab works by targeting specific cells in the immune system that may be involved in causing this inflammation. The goal of using inebilizumab in this trial is to see if it can reduce the disability caused by the disease and improve patient outcomes.

Anti-N-methyl-D-aspartate receptor encephalitis – This is a rare autoimmune disease where the body’s immune system mistakenly attacks NMDA receptors in the brain. It often begins with flu-like symptoms, followed by psychiatric symptoms such as confusion, hallucinations, or memory loss. As the disease progresses, patients may experience seizures, abnormal movements, and decreased levels of consciousness. The condition can also lead to autonomic instability, affecting heart rate and blood pressure. It is more common in young adults and children, and early recognition is crucial for management. The disease can have a relapsing course, with symptoms reappearing after initial improvement.

Trial ID:

2023-504686-23-00

Protocol code:

ExTINGUISH

NCT ID:

NCT04372615

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects and Safety of Inebilizumab for Patients with Anti-NMDA Receptor Encephalitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?