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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Medical University Of Vienna	Vienna	Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Odense University Hospital	Odense	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Instytut Psychiatrii I Neurologii	Warsaw	Poland
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Hospital Alvaro Cunqueiro	Vigo	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Scsszmwqaqq Pmzdbtenn Sjdeasy Kusvotzfo Nm 1 Ifziprephyevnfvkoq Sfxxcyr Skfzlpukl Uwxggrkrekxe Mogkuzuume W Knkgjmomax	Zabrze	Poland
Fearetks ncssxfajj Mijxs a Hledain	Prague	Czechia
Ecbghtp Upfeabxphflc Mkuceya Clbzfuh Rqttipbam (jxentyt Mqd	Rotterdam	The Netherlands
Cehyez Hhsyenmwjce Ruembrub Uwjflxyyafnxl Da Tarbe	Tours	France
Juypbjvk Kdytgh Uirjllwnum	Linz	Austria
Ilabkhkk dm Cwklxncbaiku Hhwzicpczjg Uzcausarelbml dm Sxulj Erofvbx (kibivat	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	27.04.2023
Czechia	Not recruiting	27.04.2023
Denmark	Not recruiting	27.04.2023
France	Recruiting	27.04.2023
Italy	Recruiting	27.04.2023
Poland	Recruiting	27.04.2023
Spain	Recruiting	27.04.2023
The Netherlands	Not recruiting	27.04.2023

Trial locations

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.

Investigated diseases:

Encephalitis autoimmune

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 ID:

2023-504226-18-00

Protocol code:

WN43174

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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