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New drug aims to stop relapses in rare brain disease

NCT ID NCT05271409

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether satralizumab can prevent relapses in people with MOGAD, a rare disease where the immune system attacks the brain and spinal cord. About 152 participants aged 12 and older will receive either the drug or a placebo. The main goal is to see if satralizumab delays the first relapse.

What this could mean

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

Active substance
satralizumab
What this could lead to
If it works, this could provide a new treatment to prevent relapses in people with MOGAD, reducing hospitalizations and disability.
What could go wrong
This is a single phase 3 trial with 152 participants. The drug may not significantly reduce relapses compared to 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

132 people

The number who actually took part.

Started

Aug 2022

Expected to finish

May 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 * Participants who are aged \>=12 years at the time of signing Informed Consent Form * Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening * Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening * High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening * Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening * For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab Exclusion criteria * Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum * History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis * Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses \> 20 milligrams (mg) prednisone equivalent per day for \>21 days during the study * Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab * Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline * Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) * Participants with positive screening tests for hepatitis B and C * Receipt of live or live attenuated vaccine within 6 weeks prior to baseline * History of severe allergic reaction to a biologic agent

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Conditions

The condition(s) this trial relates to.

myelin oligodendrocyte glycoprotein antibody-associated disease

As listed by the trial registrant

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

Myelin oligodendrocyte glycoprotein antibody-associated disease (mogad)

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37134, Italy

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050, Australia

  • CH de Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44915, United States

  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

    Berlin, 13125, Germany

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 9112001, Israel

  • Hopital Pierre Wertheimer

    Bron, 69677, France

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004, Brazil

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    Kanagawa, 252-0375, Japan

  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

    Warsaw, 02-097, Poland

  • Klinikum Großhadern, LMU

    Munich, 81377, Germany

  • Kobe University Hospital

    Hyōgo, 650-0017, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55902, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan, 48867, United States

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • NYU Langone

    New York, New York, 10003, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia, 6009, Australia

  • Premier Neurology

    Greenville, South Carolina, 29605, United States

  • SPSK nr 1

    Zabrze, 41-800, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Southern Tohoku Medical Clinic

    Fukushima, 963-8052, Japan

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791, Germany

  • The Jikei University Hospital

    Tokyo, 105-8471, Japan

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine - Manchester Pavilion

    Irvine, California, 92697, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine Gainesville

    Gainesville, Florida, 32608, United States

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Mannheim

    Mannheim, 68167, Germany

  • Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711, Germany

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, 40-123, Poland

More trials for these conditions

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