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

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: Recruiting
• Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
• Intervention / Treatment: Other: Placebo; Drug: Satralizumab

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WN43194 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S.); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Brain and Mind Research Institute
    • New Lambton, New South Wales, Australia, 2305
      • Withdrawn
      • John Hunter Hospital
    • Randwick, New South Wales, Australia, 2031
      • Withdrawn
      • Sydney Children's Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Withdrawn
      • Royal North Shore Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Withdrawn
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • Withdrawn
      • St Vincent's Hospital Melbourne
    • Parkville, Victoria, Australia, 3050
      • Withdrawn
      • Royal Melbourne Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Perron Institute for Neurological and Translational Science
• Brazil
  • Rio de Janeiro, Brazil, 20270-004
    • Recruiting
    • Hospital Universitario Gaffree e Guinle
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Recruiting
      • Instituto de Neurologia de Curitiba
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Recruiting
      • Instituto do Cerebro do Rio Grande do Sul
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01228-200
      • Recruiting
      • Centro de Pesquisas Clinicas
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Withdrawn
      • London Health Sciences Centre Uni Campus
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Withdrawn
      • Unity Health Toronto - St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 1X8
      • Withdrawn
      • The Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Recruiting
      • MUCH - Montreal Neurological Institute & Hospital
• France
  • Bron, France, 69677
    • Recruiting
    • Hôpital Pierre Wertheimer
  • Le Kremlin-Bicêtre, France, 94275
    • Recruiting
    • CH de Bicêtre
  • Toulouse, France, 31059
    • Withdrawn
    • CHU de Toulouse - Hôpital Purpan
• Germany
  • Berlin, Germany, 10117
    • Active, not recruiting
    • NeuroCure Clinical Research Center (NCRC)
  • Bochum, Germany, 44791
    • Active, not recruiting
    • St. Josef-Hospital, Klinik für Neurologie
  • Datteln, Germany, 45711
    • Recruiting
    • Vestische Kinder- und Jugendklinik Datteln
  • Düsseldorf, Germany, 40225
    • Active, not recruiting
    • Universitatsklinikum Dusseldorf
  • Kiel, Germany, 24105
    • Active, not recruiting
    • Neurology UKSH Campus Kiel
  • Mannheim, Germany, 68167
    • Active, not recruiting
    • Universitätsklinikum Mannheim
  • Munich, Germany, 81377
    • Active, not recruiting
    • Klinikum Großhadern, LMU
• Israel
  • Jerusalem, Israel, 9112001
    • Active, not recruiting
    • Hadassah University Hospital Ein Kerem
• Italy
  • Lazio
    • Rome, Lazio, Italy, 00165
      • Withdrawn
      • Ospedale Pediatrico Bambino Gesu
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Withdrawn
      • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Milan, Lombardy, Italy, 20132
      • Withdrawn
      • IRCCS Ospedale San Raffaele
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione Istituto Neurologico Mondino IRCCS
  • Piedmont
    • Orbassano, Piedmont, Italy, 10043
      • Recruiting
      • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Recruiting
      • AOU Policlinico V. Emanuele - P.O G. Rodolico
  • Veneto
    • Verona, Veneto, Italy, 37134
      • Recruiting
      • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Chiba, Japan, 260-8677
    • Recruiting
    • Chiba University Hospital
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Fukushima, Japan, 963-8052
    • Recruiting
    • Southern TOHOKU Medical Clinic
  • Hyōgo, Japan, 650-0017
    • Recruiting
    • Kobe University Hospital
  • Kanagawa, Japan, 252-0375
    • Recruiting
    • Kitasato University Hospital
  • Miyagi, Japan, 980-8574
    • Recruiting
    • Tohoku University Hospital
  • Miyagi, Japan, 983-8512
    • Recruiting
    • Tohoku Medical And Pharmaceutical University Hospital
  • Osaka, Japan, 565-0871
    • Recruiting
    • The University of Osaka Hospital
  • Saitama, Japan, 350-8550
    • Active, not recruiting
    • Saitama Medical Center
  • Tokyo, Japan, 113-8431
    • Recruiting
    • Juntendo University Hospital
  • Tokyo, Japan, 105-8471
    • Recruiting
    • The Jikei University Hospital
  • Tokyo, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 160-8582
    • Recruiting
    • Keio University Hospital
  • Tokyo, Japan, 162-8666
    • Withdrawn
    • Tokyo Women's Medical University Hospital
• Poland
  • Katowice, Poland, 40-123
    • Active, not recruiting
    • Wielospecjalistyczna Poradnia Lekarska Synapsis
  • Krakow, Poland, 30-688
    • Withdrawn
    • Szpital Uniwersytecki w Krakowie
  • Rzeszów, Poland, 35-055
    • Withdrawn
    • Centrum Medyczne "MEDYK"
  • Warsaw, Poland, 02-097
    • Recruiting
    • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
  • Warsaw, Poland, 04-730
    • Withdrawn
    • Instytut Pomnik Centrum Zdrowia Dziecka
  • Zabrze, Poland, 41-800
    • Active, not recruiting
    • SPSK nr 1
• South Korea
  • Goyang-si, South Korea, 10408
    • Active, not recruiting
    • National Cancer Center
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Active, not recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Withdrawn
      • Mayo Clinic- Scottsdale
  • California
    • Irvine, California, United States, 92697
      • Active, not recruiting
      • University of California Irvine - Manchester Pavilion
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Active, not recruiting
      • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Active, not recruiting
      • MedStar Georgetown University Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • Active, not recruiting
      • University of Florida College of Medicine Gainesville
    • Jacksonville, Florida, United States, 32207
      • Withdrawn
      • Nemours Children's Clinic - of the Nemours Foundation
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Withdrawn
      • Meridian Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Withdrawn
      • Northwestern University
    • Northbrook, Illinois, United States, 60062
      • Withdrawn
      • Consultants in Neurology Ltd
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Active, not recruiting
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Owosso, Michigan, United States, 48867
      • Active, not recruiting
      • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Active, not recruiting
      • Mayo Clinic - Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University School of Medicine in St. Louis
  • New York
    • New York, New York, United States, 10003
      • Active, not recruiting
      • NYU Langone
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Withdrawn
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Active, not recruiting
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44915
      • Active, not recruiting
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • Withdrawn
      • OhioHealth Research Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Completed
      • Premier Neurology
  • Texas
    • Houston, Texas, United States, 77030
      • Withdrawn
      • Baylor College of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Completed
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	Up to approximately 44 months

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): November 20, 2025
• Study Completion (Estimated): May 20, 2028

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; satralizumab
• Other Study ID Numbers: WN43194; 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