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Clinical Trial NCT05271409 (Meteoroid) for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (Meteoroid) Phase 3 152 Double-Blind Adolescent Open-Label

Recruiting
Clinical Trial NCT05271409 (Meteoroid) is designed to study Treatment for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). It is a Phase 3 interventional study that is recruiting, having started on 30 August 2022, with plans to enroll 152 participants. Led by Hoffmann-La Roche, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 13 March 2026.
Brief 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. 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 adolescen...Show More
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)

Conditions
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Other Study IDs
  • Meteoroid
  • WN43194
  • 2021-003192-34 (EudraCT Number)
  • 2023-507196-22-00 (EU Study (CTIS) Number)
NCT ID Number
NCT05271409
Start Date (Actual)
2022-08-30
Last Update Posted
2026-03-13
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
152
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSatralizumab
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.
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 ComparatorPlacebo
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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)
Up to approximately 44 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Annualized Rate of Adjudicated MOGAD Relapses
Up to approximately 44 months
Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis
Up to approximately 44 months
Proportion of Participants Receiving Rescue Therapy
Up to approximately 44 months
Annualized Rate of Inpatient Hospitalizations
Up to approximately 44 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
  • 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

  • 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
Hoffmann-La Roche logoHoffmann-La Roche289 active studies to explore
Chugai Pharmaceutical logoChugai Pharmaceutical
Study Central Contact
Contact: Reference Study ID Number: WN43194 https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
82 Study Locations in 11 Countries

Alabama

University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Recruiting

Arizona

Mayo Clinic- Scottsdale, Scottsdale, Arizona, 85259, United States
Withdrawn

California

University of California Irvine - Manchester Pavilion, Irvine, California, 92697, United States
Recruiting

Colorado

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center), Aurora, Colorado, 80045, United States
Recruiting

District of Columbia

Medstar Georgetown University Hospital, Washington D.C., District of Columbia, 20007, United States
Recruiting

Florida

University of Florida College of Medicine Gainesville, Gainesville, Florida, 32608, United States
Recruiting
Nemours Children's Clinic - of the Nemours Foundation, Jacksonville, Florida, 32207, United States
Recruiting

Georgia

Meridian Clinical Research, LLC, Savannah, Georgia, 31406, United States
Withdrawn

Illinois

Northwestern University, Chicago, Illinois, 60611, United States
Withdrawn
Consultants in Neurology Ltd, Northbrook, Illinois, 60062, United States
Withdrawn

Maryland

Johns Hopkins, Baltimore, Maryland, 21287, United States
Recruiting

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Recruiting

Michigan

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis, Owosso, Michigan, 48867, United States
Recruiting

Minnesota

Mayo Clinic - Rochester, Rochester, Minnesota, 55902, United States
Recruiting

Missouri

Washington University School of Medicine in St. Louis, St Louis, Missouri, 63110, United States
Recruiting

New York

NYU Langone, New York, New York, 10003, United States
Recruiting

North Carolina

Duke University Medical Center, Durham, North Carolina, 27710, United States
Withdrawn

Ohio

University of Cincinnati, Cincinnati, Ohio, 45267, United States
Active, not recruiting
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
Recruiting
OhioHealth Research Institute, Columbus, Ohio, 43214, United States
Withdrawn

South Carolina

Premier Neurology, Greenville, South Carolina, 29605, United States
Completed

Texas

Baylor College of Medicine, Houston, Texas, 77030, United States
Withdrawn

Wisconsin

Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Completed

New South Wales

Brain and Mind Research Institute, Camperdown, New South Wales, 2050, Australia
Recruiting
John Hunter Hospital, New Lambton, New South Wales, 2305, Australia
Recruiting
Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia
Recruiting
Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia
Withdrawn

Victoria

Box Hill Hospital, Box Hill, Victoria, 3128, Australia
Withdrawn
Monash Medical Centre, Clayton, Victoria, 3168, Australia
Recruiting
St Vincent's Hospital Melbourne, Fitzroy, Victoria, 3065, Australia
Withdrawn
Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia
Withdrawn

Western Australia

Perron Institute for Neurological and Translational Science, Nedlands, Western Australia, 6009, Australia
Recruiting

Paraná

Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
Recruiting

Rio Grande do Sul

Instituto do Cerebro do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Recruiting

São Paulo

Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
Recruiting
Hospital Universitario Gaffree e Guinle, Rio de Janeiro, 20270-004, Brazil
Recruiting

Ontario

London Health Sciences Centre Uni Campus, London, Ontario, N6A 5A5, Canada
Recruiting
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
Recruiting
Unity Health Toronto - St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada
Withdrawn
The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
Recruiting

Quebec

MUCH - Montreal Neurological Institute & Hospital, Montreal, Quebec, H3A 2B4, Canada
Recruiting
Hopital Pierre Wertheimer, Bron, 69677, France
Recruiting
CH de Bicêtre, Le Kremlin-Bicêtre, 94275, France
Recruiting
CHU de Toulouse - Hôpital Purpan, Toulouse, 31059, France
Withdrawn
NeuroCure Clinical Research Center (NCRC), Berlin, 10117, Germany
Active, not recruiting
St. Josef-Hospital, Klinik für Neurologie, Bochum, 44791, Germany
Active, not recruiting
Vestische Kinder- und Jugendklinik Datteln, Datteln, 45711, Germany
Recruiting
Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany
Active, not recruiting
Neurology UKSH Campus Kiel, Kiel, 24105, Germany
Active, not recruiting
Universitätsklinikum Mannheim, Mannheim, 68167, Germany
Active, not recruiting
Klinikum Großhadern, LMU, Munich, 81377, Germany
Active, not recruiting
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Recruiting

Lazio

Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Active, not recruiting

Lombardy

IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Active, not recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Withdrawn
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Recruiting

Piedmont

Azienda Sanitaria Ospedaliera S. Luigi Gonzaga, Orbassano, Piedmont, 10043, Italy
Recruiting

Sicily

AOU Policlinico V. Emanuele - P.O G. Rodolico, Catania, Sicily, 95123, Italy
Recruiting

Veneto

Azienda Ospedaliera Universitaria Integrata Verona, Verona, Veneto, 37134, Italy
Recruiting
Chiba University Hospital, Chiba, 260-8677, Japan
Recruiting
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Recruiting
Southern Tohoku Medical Clinic, Fukushima, 963-8052, Japan
Recruiting
Kobe University Hospital, Hyōgo, 650-0017, Japan
Recruiting
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Recruiting
Tohoku University Hospital, Miyagi, 980-8574, Japan
Recruiting
Tohoku Medical and Pharmaceutical University Hospital, Miyagi, 983-8512, Japan
Recruiting
The University of Osaka Hospital, Osaka, 565-0871, Japan
Recruiting
Saitama Medical Center, Saitama, 350-8550, Japan
Recruiting
The Jikei University Hospital, Tokyo, 105-8471, Japan
Recruiting
Juntendo University Hospital, Tokyo, 113-8431, Japan
Recruiting
Tokyo Medical University Hospital, Tokyo, 160-0023, Japan
Recruiting
Keio University Hospital, Tokyo, 160-8582, Japan
Recruiting
Tokyo Women's Medical University Hospital, Tokyo, 162-8666, Japan
Withdrawn
Wielospecjalistyczna Poradnia Lekarska Synapsis, Katowice, 40-123, Poland
Recruiting
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Withdrawn
Centrum Medyczne "MEDYK", Rzeszów, 35-055, Poland
Withdrawn
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warsaw, 02-097, Poland
Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw, 04-730, Poland
Recruiting
SPSK nr 1, Zabrze, 41-800, Poland
Active, not recruiting
National Cancer Center, Goyang-si, 10408, South Korea
Recruiting
Seoul National University Hospital, Seoul, 03080, South Korea
Active, not recruiting
Samsung Medical Center, Seoul, 06351, South Korea
Recruiting