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

September 3, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Brain and Mind Research Institute
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perron Institute for Neurological and Translational Science
  • Brazil
      • Rio de Janeiro, Brazil, 20270-004
        • Hospital Universitario Gaffree e Guinle
    • Paraná
      • Curitiba, Paraná, Brazil, 81210-310
        • Instituto de Neurologia de Curitiba
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Instituto do Cerebro do Rio Grande do Sul
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-200
        • Centro de Pesquisas Clinicas
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • MUCH - Montreal Neurological Institute & Hospital
  • France
      • Bron, France, 69677
        • Hopital Pierre Wertheimer
      • Le Kremlin-Bicêtre, France, 94275
        • CH de Bicêtre
  • Germany
      • Berlin, Germany, 13125
        • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
      • Bochum, Germany, 44791
        • St. Josef-Hospital, Klinik für Neurologie
      • Datteln, Germany, 45711
        • Vestische Kinder- und Jugendklinik Datteln
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim
      • Munich, Germany, 81377
        • Klinikum Großhadern, LMU
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital Ein Kerem
  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Fondazione Istituto Neurologico Mondino IRCCS
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukushima, Japan, 963-8052
        • Southern TOHOKU Medical Clinic
      • Hyōgo, Japan, 650-0017
        • Kobe University Hospital
      • Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Osaka, Japan, 565-0871
        • The University of Osaka Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Japan, 105-8471
        • The Jikei University Hospital
  • Poland
      • Katowice, Poland, 40-123
        • Wielospecjalistyczna Poradnia Lekarska Synapsis
      • Warsaw, Poland, 02-097
        • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
      • Zabrze, Poland, 41-800
        • SPSK nr 1
  • South Korea
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Irvine, California, United States, 92697
        • University of California Irvine - Manchester Pavilion
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida College of Medicine Gainesville
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Owosso, Michigan, United States, 48867
        • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic - Rochester
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine in St. Louis
    • New York
      • New York, New York, United States, 10003
        • NYU Langone
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44915
        • Cleveland Clinic Foundation
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Premier Neurology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Satralizumab
In 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.
Drug: Satralizumab
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.
Placebo Comparator: Placebo
In 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.
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Up to approximately 44 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Annualized Rate of Adjudicated MOGAD Relapses
Time Frame: Up to approximately 44 months
Up to approximately 44 months
Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis
Time Frame: Up to approximately 44 months
Up to approximately 44 months
Proportion of Participants Receiving Rescue Therapy
Time Frame: Up to approximately 44 months
Up to approximately 44 months
Annualized Rate of Inpatient Hospitalizations
Time Frame: Up to approximately 44 months
Up to approximately 44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WN43194
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2021-003192-34 (EudraCT Number)
  • 2023-507196-22-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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