Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Satralizumab for Patients with Autoimmune Encephalitis (NMDAR or LGI1)

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a condition known as autoimmune encephalitis, which is a type of brain inflammation caused by the immune system mistakenly attacking healthy brain cells. Specifically, the study is looking at two forms of this condition: NMDAR encephalitis and LGI1 encephalitis. The treatment being tested is called Satralizumab, which is given as a solution for injection. Satralizumab is being compared to a placebo to see how effective it is in reducing the symptoms and severity of these conditions.

The purpose of the study is to evaluate how well Satralizumab works in improving the condition of patients with autoimmune encephalitis and to assess its safety over a longer period. Participants in the study will receive either Satralizumab or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will monitor participants over a period of time to see if there is an improvement in their symptoms, such as a reduction in disability and clinical severity, without the need for additional rescue therapy.

Throughout the study, researchers will also keep track of any side effects or adverse events that participants may experience. The study aims to provide valuable information on the potential benefits and risks of using Satralizumab for treating autoimmune encephalitis, helping to determine if it can be a safe and effective treatment option for patients with these specific types of brain inflammation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be assessed to ensure they meet the inclusion criteria. This includes confirming the diagnosis of NMDAR or LGI1 encephalitis and ensuring the onset of symptoms occurred within nine months before randomization.

  2. Step 2

    Randomization and initial treatment

    The patient will be randomly assigned to receive either satralizumab or a placebo. Satralizumab is administered as a subcutaneous injection, which means it is injected under the skin.

    The initial phase of the study focuses on evaluating the effectiveness of satralizumab compared to a placebo in reducing disability and clinical severity over a 24-week period.

  3. Step 3

    Treatment administration

    The patient will receive satralizumab or placebo injections at specified intervals. The exact dosage and frequency will be determined by the study protocol and communicated to the patient by the study team.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor their condition. This includes evaluating changes in the Modified Rankin Scale (mRS) score, which measures the degree of disability, and other health indicators.

    The patient will also be monitored for any adverse events or side effects related to the treatment.

  5. Step 5

    Evaluation at week 24

    At the 24-week mark, the patient's progress will be evaluated. The primary goal is to determine if there has been a 1-point improvement in the mRS score without the need for additional rescue therapy.

    Secondary evaluations will include assessments of seizure cessation, cognitive function, and overall health status.

  6. Step 6

    Long-term safety and tolerability

    Following the initial 24-week period, the study will continue to assess the long-term safety and tolerability of satralizumab. This phase aims to gather more data on the sustained effects and any long-term side effects of the treatment.

Who can join the trial?

7 criteria

  • The patient must have a reasonable exclusion of a tumor or cancer before the first visit for the study.
  • The patient should have started showing symptoms of **autoimmune encephalitis** (a condition where the body's immune system attacks the brain) within the last 9 months.
  • The patient must meet the definition of "New Onset" (recently diagnosed) or "Incomplete Responder" (not fully responding to treatment) for autoimmune encephalitis.
  • The patient should have a diagnosis of probable or definite **NMDAR encephalitis** (a specific type of autoimmune encephalitis affecting the brain).
  • The patient should have a diagnosis of **LGI1 encephalitis** (another specific type of autoimmune encephalitis).
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means it considers people who might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection or illness that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have used certain medications recently that could affect the study.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
  • Patients who have a condition that affects their ability to understand or follow study instructions.
  • Patients who have a history of certain mental health conditions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Satralizumab is a medication being studied for its effectiveness and safety in treating patients with certain types of encephalitis, specifically those with anti-N-Methyl-D-Aspartic Acid Receptor (NMDAR) or anti-Leucine-Rich Glioma-Inactivated 1 (LGI1) encephalitis. This medication is being tested to see if it can help reduce the severity of symptoms and improve the overall condition of patients by decreasing disability and clinical severity. The study also aims to assess the long-term safety and tolerability of satralizumab for these conditions.

What is already known about the treatment

Satralizumab – Satralizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness and safety in treating autoimmune encephalitis mediated by NMDAR or LGI1. The main therapeutic indication for satralizumab is to reduce disability and clinical severity in patients with these conditions. At the molecular level, satralizumab works by blocking the interleukin-6 receptor, which plays a role in the inflammatory process. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

  • Anti-NMDA Receptor Encephalitis

    This is an autoimmune disorder 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 agitation. As the disease progresses, patients may experience seizures, memory problems, and movement disorders. The condition can also lead to decreased consciousness and autonomic instability, affecting heart rate and blood pressure. It is more common in young adults and children, with a higher prevalence in females. Early recognition and management are crucial to prevent further neurological damage.

  • LGI1 Antibody Encephalitis

    This is an autoimmune disease where antibodies target the LGI1 protein, affecting the brain's limbic system. It typically presents with memory loss, confusion, and seizures, often characterized by brief, involuntary muscle contractions. Patients may also experience sleep disturbances and personality changes. The disease can lead to cognitive decline if not addressed promptly. It is more frequently observed in middle-aged and older adults, with a slight male predominance. Understanding the symptoms is essential for timely intervention and management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504226-18-00Protocol codeWN43174Estimated enrolment181 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.