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Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)Phase 3MeteoroidNCT05271409

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

A Phase 3 study testing Satralizumab in people with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), run by Hoffmann-La Roche at 53 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Satralizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
53 sitesin 11 countries
Study dates
30 Aug 2022to 20 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

53 sites in 11 countries.

53 sites in 11 countries

United States15 sites

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

    Aurora, Colorado, 80045

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44915

  • University of Florida College of Medicine Gainesville

    Gainesville, Florida, 32608

  • Premier Neurology

    Greenville, South Carolina, 29605

  • University of California Irvine - Manchester Pavilion

    Irvine, California, 92697

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone

    New York, New York, 10003

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan, 48867

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55902

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan11 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Southern Tohoku Medical Clinic

    Fukushima, 963-8052

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • Tohoku University Hospital

    Miyagi, 980-8574

  • The University of Osaka Hospital

    Osaka, 565-0871

  • The Jikei University Hospital

    Tokyo, 105-8471

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Germany6 sites

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

    Berlin, 13125

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791

  • Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Klinikum Großhadern, LMU

    Munich, 81377

Other trials in Germany

Brazil4 sites

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200

Other trials in Brazil

Australia3 sites

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia, 6009

Other trials in Australia

Italy3 sites

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37134

Other trials in Italy

Poland3 sites

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, 40-123

  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

    Warsaw, 02-097

  • SPSK nr 1

    Zabrze, 41-800

Other trials in Poland

South Korea3 sites

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Canada2 sites

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec, H3A 2B4

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

France2 sites

  • Hopital Pierre Wertheimer

    Bron, 69677

  • CH de Bicêtre

    Le Kremlin-Bicêtre, 94275

Other trials in France

Israel1 site

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 9112001

Other trials in Israel

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.

Being tested
Satralizumab, Placebo
Medical subject headings
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SatralizumabDrug

    Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.

  • PlaceboOther

    Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.

Study groups in NCT05271409
Study groupRoleWhat they receive
SatralizumabExperimentalIn the DB treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open-label treatment with satralizumab. Additional adolescent participants will be directly enrolled in the OLE period to receive satralizumab.
Receives: Drug: Satralizumab
PlaceboPlacebo comparatorIn the DB treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses Q4W thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)

    Measured: Up to approximately 44 months

Secondary outcomes (4)

  1. Annualized Rate of Adjudicated MOGAD Relapses

    Measured: Up to approximately 44 months

  2. Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis

    Measured: Up to approximately 44 months

  3. Proportion of Participants Receiving Rescue Therapy

    Measured: Up to approximately 44 months

  4. Annualized Rate of Inpatient Hospitalizations

    Measured: Up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start30 Aug 2022
  3. Primary completion20 Nov 2025
  4. Study completion20 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271409
Sponsor's protocol ID
WN43194
Other IDs
2021-003192-34, 2023-507196-22-00, 2023
Acronym
Meteoroid
Status last verified
Oct 2026
First submitted
28 Feb 2022
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Satralizumab in people with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), run by Hoffmann-La Roche at 53 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, Germany, Brazil, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC) (time frame: Up to approximately 44 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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