Ongoing Clinical Trials for Autoimmune Encephalitis
Currently, there are 3 ongoing clinical trials exploring new treatments for autoimmune encephalitis, a serious condition where the immune system mistakenly attacks the brain. These trials are investigating different medications that may help reduce brain inflammation and improve patient outcomes. The studies are being conducted across multiple European countries and include patients with various forms of the disease, including NMDAR and LGI1 encephalitis.
Clinical trial locations
- Austria
- Czechia
- Denmark
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
Study on Bortezomib for Patients with Severe Autoimmune Encephalitis
This trial is investigating bortezomib, a medication that works by reducing immune system activity, for patients with severe forms of the disease. The study aims to determine whether bortezomib can help decrease brain inflammation and improve neurological symptoms.
Who can participate: Patients aged 18 years or older with a confirmed diagnosis of severe disease, defined by a score of 3 or higher on a specific disability scale. Participants must have autoantibodies against nerve cell surface proteins detected in their cerebrospinal fluid or blood within the last four weeks. Additionally, patients must have previously received treatment with rituximab. Women of childbearing potential must have a negative pregnancy test.
Who cannot participate: The trial excludes patients who have a different neurological condition, those outside the specified age range, or individuals who do not meet other specific medical criteria for the study.
Study focus: The trial will monitor participants over 17 weeks, administering bortezomib through the skin. Researchers will assess changes in disability levels, hospital stay duration, antibody levels, and overall brain function. Safety evaluations will focus on potential side effects including nerve damage, liver problems, blood-related issues, digestive complications, and infections.
Study on the Effects and Safety of Inebilizumab for Patients with Anti-NMDA Receptor Encephalitis
This trial focuses specifically on anti-NMDA receptor encephalitis, a form of the disease where the immune system attacks NMDA receptors in the brain. The study is testing inebilizumab, a medication designed to target specific immune cells that may contribute to brain inflammation.
Who can participate: Patients between 18 and 65 years old with confirmed anti-NMDA receptor encephalitis and a disability score of 3 or higher on the mRS scale. Participants must have received at least three days of high-dose methylprednisolone within 30 days before joining the study, plus either intravenous immunoglobulin therapy or plasma exchange with at least five sessions. Patients must be willing to stop other immune-suppressing treatments during the trial.
Who cannot participate: The trial excludes pregnant or breastfeeding women, those who have recently participated in other clinical trials, patients with other significant medical conditions that might interfere with study results, and individuals unable to provide informed consent.
Study focus: Participants will receive either inebilizumab or placebo in addition to standard care, administered through intravenous infusion. The primary goal is to assess changes in disability levels at 16 weeks using the mRS scale. The study will also evaluate time to improvement, cognitive outcomes, overall survival, and safety through tracking of adverse events over 24 weeks.
Study on the Effects of Satralizumab for Patients with Autoimmune Encephalitis (NMDAR or LGI1)
This study is examining satralizumab for patients with two specific types of the disease: NMDAR encephalitis and LGI1 encephalitis. Satralizumab is a medication that blocks a specific inflammatory pathway in the body by targeting the interleukin-6 receptor.
Who can participate: The trial accepts both male and female patients who have been diagnosed with either NMDAR or LGI1 encephalitis, with symptom onset within the past nine months. Patients must meet the definition of either “new onset” (recently diagnosed) or “incomplete responder” (not fully responding to previous treatment). A thorough evaluation to exclude tumors must be completed before joining the study.
Who cannot participate: Pregnant or breastfeeding women, patients with recent infections or serious health conditions that could affect study results, those currently participating in another trial, individuals with a history of severe allergic reactions to medications, recent drug or alcohol abuse, planned surgery during the study period, or certain mental health conditions are not eligible.
Study focus: Participants will receive satralizumab or placebo through injections under the skin at regular intervals. The study will evaluate effectiveness over 24 weeks by measuring improvements in disability scores without the need for additional rescue therapy. Researchers will also assess seizure cessation, cognitive function, and overall health status, while monitoring long-term safety and tolerability of the treatment.
Summary
These three clinical trials represent important research efforts to find effective treatments for different forms of this challenging condition. The trials are testing three distinct medications—bortezomib, inebilizumab, and satralizumab—each working through different mechanisms to reduce immune system attacks on the brain.
Geographically, the research shows a strong concentration in Western Europe, with the satralizumab trial spanning the widest network across eight countries including Denmark, Poland, Spain, Austria, Netherlands, Italy, France, and Czechia. The Netherlands is particularly active, hosting two of the three trials. Germany and Spain each host two trials, demonstrating their commitment to advancing treatment options.
The trials address different patient populations and disease severities. The bortezomib study specifically targets severe cases in patients who have already tried rituximab therapy. The inebilizumab trial focuses exclusively on anti-NMDA receptor encephalitis with specific pre-treatment requirements. The satralizumab study takes the broadest approach, including both NMDAR and LGI1 encephalitis patients with varying response levels to previous treatments.
All three trials share common goals of reducing disability, improving neurological function, and carefully monitoring safety. Each study uses different administration methods—bortezomib through the skin, inebilizumab and satralizumab through injections—and varying treatment durations, reflecting the complexity of finding optimal therapeutic approaches for these conditions.
