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New drug trial aims to tame rare brain inflammation

NCT ID NCT05503264

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This Phase 3 trial tests satralizumab, an injected drug, in 120 people with NMDAR or LGI1 encephalitis—rare conditions where the immune system attacks the brain. The goal is to see if the drug improves disability and reduces the need for rescue treatments. Participants receive either satralizumab or a placebo for up to 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
satralizumab (Enspryng)
What this could lead to
If successful, satralizumab could offer a new treatment option to control symptoms and reduce disability in people with autoimmune encephalitis.
What could go wrong
This is an early Phase 3 trial with only 120 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

122 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Reasonable exclusion of tumor or malignancy before baseline visit (randomization) * Onset of AIE symptoms ≤ 9 months before randomization * Meet the definition of "New Onset" or "Incomplete Responder" AIE * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo * For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry NMDAR AIE Cohort: * Age ≥ 12 years * Diagnosis of probable or definite NMDAR encephalitis LGI1 AIE Cohort * Age ≥ 18 years * Diagnosis of LGI1 encephalitis Exclusion Criteria: * Any untreated teratoma or thymoma at baseline visit (randomization) * History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening * For participants with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset * Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65) * Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity * Confirmed paraneoplastic encephalitis * Confirmed central nervous system (CNS) or peripheral nervous system (PNS) demyelinating disease * Alternative causes of associated symptoms * History of herpes simplex virus encephalitis in the previous 24 weeks * Any previous/concurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation * Any previous treatment with anti-cluster of differentiation 19 antibody (CD19 antibody), complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody * Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone * Treatment with oral cyclophosphamide within 1 year prior to baseline * Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening * Concurrent use of more than one immunosuppressive therapy (IST) as background therapy * Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV) cyclophosphamide * Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal * Planned surgical procedure during the study * Evidence of progressive multifocal leukoencephalopathy * Evidence of serious uncontrolled concomitant diseases * Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection * Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection * Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit * Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening * Evidence of latent or active tuberculosis (TB) * History of drug or alcohol abuse within 1 year prior to baseline * History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation * Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit * History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening * History of severe allergic reaction to a biologic agent * History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study * Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug

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Conditions

The condition(s) this trial relates to.

anti-NMDA receptor encephalitis limbic encephalitis with LGI1 antibodies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LGI1 autoimmune encephalitis Nmdar autoimmune encephalitis

Contacts and locations

Locations

  • A. O. U. Federico II

    Naples, Campania, 80131, Italy

  • AOU Policlinico Giaccone

    Palermo, Sicily, 90129, Italy

  • Affiliated Hospital of Jining Medical University

    Jining, 272029, China

  • Ageo Central General Hospital

    Saitama, 362-8588, Japan

  • Beijing Children's Hospital, Capital Medical University

    Beijing, 100045, China

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, China

  • Beijing Tongren Hospital

    Beijing, 100730, China

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02115, United States

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450, Brazil

  • CHRU - Hôpital Bretonneau

    Tours, 37000, France

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 333, Taiwan

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Children's Healthcare of Atlanta Center for Advanced Pediatrics

    Atlanta, Georgia, 30329, United States

  • Childrens National Health Center

    Washington D.C., District of Columbia, 20010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44915, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Fujita Health University Hospital

    Aichi, 470-1192, Japan

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • Gifu University Hospital

    Gifu, 501-1194, Japan

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 9112001, Israel

  • Hoag Memorial Hospital

    Newport Beach, California, 92658, United States

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Pitié Salpétrière - CHU

    Paris, 75651, France

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677, France

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, DUMMY_VALUE, Spain

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB, Argentina

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Geral de Fortaleza

    Fortaleza, Ceará, 60175-295, Brazil

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05652-000, Brazil

  • Hospital Ramos Mejía

    CABA, C1221ADC, Argentina

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Hyogo prefectural Kobe Children's Hospital

    Hyogoken, 6500047, Japan

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957, Poland

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kagoshima City Hospital

    Kagoshima, 890-8760, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 00833, Taiwan

  • Kindai University Hospital

    Osaka, 590-0197, Japan

  • Kitasato University Hospital

    Kanagawa, 252-0375, Japan

  • Kobe University Hospital

    Hyōgo, 650-0017, Japan

  • Komfo Anokye Teaching Hospital

    Kumasi, Ghana

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • NYU-Langone Medical Center

    New York, New York, 10016, United States

  • National Neuroscience Institute

    Singapore, 308433, Singapore

  • National University Hospital (NUH)

    Singapore, 117599, Singapore

  • Nihon University Itabashi Hospital

    Tokyo, 173-8610, Japan

  • Odense Universitetshospital, Neurologisk Afdeling N

    Odense C, 5000, Denmark

  • SPSK nr 1

    Zabrze, 41-800, Poland

  • Sanatorio del Sur S.A.

    San Miguel de Tucumán, T4000IDK, Argentina

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St.Marianna University School of Medicine hospital

    Kanagawa, 216-8511, Japan

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325035, China

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokai University Hospital

    Kanagawa, 259-1193, Japan

  • UC San Diego

    La Jolla, California, 92037, United States

  • UCSF- Multiple Sclerosis Centre

    San Francisco, California, 94158, United States

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Texas at Houston

    Houston, Texas, 77030, United States

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.