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Study on Bortezomib for Patients with Severe Autoimmune Encephalitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called bortezomib in patients with a condition known as autoimmune encephalitis. Autoimmune encephalitis is a serious disease where the body's immune system mistakenly attacks the brain, leading to inflammation and various neurological symptoms. The purpose of this study is to evaluate how effective and safe bortezomib is for treating this condition.

Participants in the study will receive either bortezomib or a placebo. Bortezomib is a chemical compound that is administered through the skin. The study will last for a period of 17 weeks, during which participants will be closely monitored. The researchers will assess the participants' health and any changes in their condition at different points throughout the study. This will help determine the impact of bortezomib on the symptoms of autoimmune encephalitis.

Throughout the study, various health indicators will be measured, including the length of hospital stays, changes in antibody levels, and overall brain function. The safety of bortezomib will also be evaluated, with particular attention to any side effects such as nerve damage, liver issues, blood-related problems, digestive issues, and infections. This comprehensive approach aims to provide a clear understanding of how bortezomib can help patients with autoimmune encephalitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of severe autoimmune encephalitis. This includes checking for specific autoantibodies in the cerebrospinal fluid or blood, which must have been detected within the last four weeks.
A review of previous treatments, including rituximab, is performed. Eligibility is confirmed based on age (18 years or older) and a negative pregnancy test for those who are potentially fertile.
Step 2
Randomization and baseline visit
Participants are randomly assigned to receive either the investigational product, bortezomib, or a placebo. This process is double-blinded, meaning neither the participant nor the study team knows which treatment is being administered.
A baseline visit is conducted to assess neurocognitive function and collect samples for antibody titers and immune response analysis.
Step 3
Treatment administration
The investigational product, bortezomib, is administered through the skin (percutaneous use). The specific dosage and frequency are determined by the study protocol.
The treatment period lasts for 17 weeks, during which the participant's health and response to the treatment are closely monitored.
Step 4
Follow-up assessments
Follow-up assessments are conducted at 3, 6, 9, and 13 weeks after the first administration of the investigational product. These assessments include evaluations of the participant's condition using the mRS and GCS scales, which measure disability and consciousness levels, respectively.
Additional assessments include monitoring the length of hospital stay, antibody levels, immune response, and neurocognitive function.
Step 5
Final evaluation
A final evaluation is conducted 17 weeks after the first administration of the investigational product. This includes a comprehensive assessment of the participant's condition, including any adverse events experienced during the trial.
Safety evaluations focus on potential side effects of bortezomib, such as nerve damage, liver enzyme changes, blood toxicity, digestive issues, and infections.

Who can join the trial?

6 criteria

The patient must have been clinically diagnosed with **severe autoimmune encephalitis**. This is a condition where the body's immune system attacks the brain, causing inflammation. The severity is defined by a score of 3 or higher on a specific scale used by doctors.
The patient must have **autoantibodies** against proteins on the surface of nerve cells. These are special proteins made by the immune system that mistakenly target the brain. The presence of these autoantibodies must be confirmed in the fluid around the brain and spine or in the blood, and the test must have been done within the last 4 weeks.
The patient must have been treated with **rituximab** before. Rituximab is a medication used to treat certain autoimmune diseases.
The patient must be **18 years or older**.
The patient must provide **written informed consent**. This means the patient agrees to participate in the study after being fully informed about it. If the patient cannot write due to physical reasons, a witness can help, or a legal or authorized representative can provide consent on their behalf.
If the patient is a woman who could potentially become pregnant (up to 2 years after menopause), she must have a **negative pregnancy test**.

Who cannot join the trial?

4 criteria

Patients who have a different condition than autoimmune encephalitis cannot participate. Autoimmune encephalitis is a condition where the body's defense system mistakenly attacks the brain.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
Patients who do not meet the gender requirements for the study cannot participate. The study includes both male and female participants.
Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that might need special protection or care.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
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Mainz, Germany
Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Goethe University Frankfurt
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Frankfurt, Germany

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Investigated drugs

Bortezomib is a medication being studied for its effectiveness and safety in treating patients with severe autoimmune encephalitis. Autoimmune encephalitis is a condition where the immune system mistakenly attacks the brain, leading to inflammation. Bortezomib is thought to help by reducing the activity of the immune system, potentially decreasing inflammation and improving symptoms in affected patients.

What is already known about the treatment

Bortezomib – Bortezomib is administered as an injection, typically given under the skin or into a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating severe autoimmune encephalitis, a condition where the immune system mistakenly attacks the brain. The medication works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, thereby affecting the survival of certain immune cells. Bortezomib is classified as a proteasome inhibitor and is already used in the treatment of certain types of cancer, such as multiple myeloma.

Investigated diseases

Autoimmune Encephalitis – Autoimmune encephalitis is a condition where the body's immune system mistakenly attacks the brain, leading to inflammation. This can result in a variety of neurological and psychiatric symptoms, such as confusion, memory loss, seizures, and changes in behavior. The disease can progress rapidly, with symptoms worsening over days to weeks. As the inflammation affects different parts of the brain, individuals may experience difficulties with movement, speech, and cognition. The severity and specific symptoms can vary widely among individuals. Early recognition and management are crucial to prevent long-term complications.