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

Last updated: March 13, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Satralizumab

Clinical Study ID

NCT05271409
WN43194
  • Ages > 12
  • All Genders

Study Summary

The main objective of the 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

Eligibility Criteria

Inclusion

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

  • Best corrected 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 (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 OCS or intravenous (IV) corticosteroids at doses >20 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 Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 30, 2022
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Brain and Mind Research Institute

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton, New South Wales 2305
    Australia

    Active - Recruiting

  • Sydney Children's Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Royal North Shore Hospital; Department of Neurology

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Box Hill Hospital; Department of Neurology

    Box Hill, Victoria 3128
    Australia

    Completed

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Royal Childrens Hospital; Childrens Neuroscience Centre

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Royal Melbourne Hospital; Department of Neurology

    Parkville, Victoria 3050
    Australia

    Completed

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná 81210-310
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, RS 90610-000
    Brazil

    Site Not Available

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Clinicas; CPCLIN

    Sao Paulo, SP 01228-200
    Brazil

    Active - Recruiting

  • Hospital das Clinicas - FMUSP

    Sao Paulo, SP 05403-900
    Brazil

    Site Not Available

  • Centro de Pesquisas Clinicas

    Sao Paulo, São Paulo 01228-200
    Brazil

    Active - Recruiting

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004
    Brazil

    Active - Recruiting

  • Hamilton Health Sciences - General Site

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Unity Health Toronto - St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • Beijing Children's Hospital, Capital Medical University

    Beijing City, 100045
    China

    Site Not Available

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing City, 100050
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing City, 100032
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha City, 410008
    China

    Site Not Available

  • West China Hospital - Sichuan University

    Chengdu City, 610047
    China

    Site Not Available

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou City, 310018
    China

    Site Not Available

  • Children's Hospital of Fudan University

    Shanghai, 201102
    China

    Site Not Available

  • Huashan Hospital Affiliated to Fudan University

    Shanghai City, 200040
    China

    Site Not Available

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Site Not Available

  • Hopital Pierre Wertheimer

    Bron, 69677
    France

    Active - Recruiting

  • Hopital Pierre Wertheimer; Neurologie D

    Bron, 69677
    France

    Active - Recruiting

  • CH de Bicêtre

    Le Kremlin Bicêtre, 94275
    France

    Active - Recruiting

  • APHP - Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • CHU de Toulouse - Hôpital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Charite - Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Site Not Available

  • NeuroCure Clinical Research Center (NCRC)

    Berlin, 10117
    Germany

    Active - Recruiting

  • NeuroCure Clinical Research Center (NCRC); Clinical Neuroimmunology; Charitè Campus Mitte

    Berlin, 10117
    Germany

    Active - Recruiting

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791
    Germany

    Active - Recruiting

  • Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf; Klinik für Neurologie

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Neurology UKSH Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitätsklinikum Mannheim; Neurologische Klinik

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Klinikum Großhadern, LMU

    Munich, 81377
    Germany

    Active - Recruiting

  • Klinikum Großhadern, LMU; Institut für klinische Neuroimmunologie

    Munich, 81377
    Germany

    Active - Recruiting

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah University Hospital Ein Kerem; Neurology Department

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

    Orbassano, Piemonte 10043
    Italy

    Active - Recruiting

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

    Orbassano, Piemonte 10043
    Italy

    Active - Recruiting

  • AOU Policlinico V. Emanuele - P.O G. Rodolico

    Catania, Sicilia 95123
    Italy

    Active - Recruiting

  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

    Catania, Sicilia 95123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto 37134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona; Neurologia B

    Verona, Veneto 37134
    Italy

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Southern Tohoku Medical Clinic

    Fukushima, 963-8052
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Hyogo, 650-0017
    Japan

    Active - Recruiting

  • Kitasato University Hospital

    Kanagawa, 252-0375
    Japan

    Active - Recruiting

  • Tohoku Medical and Pharmaceutical University Hospital

    Miyagi, 983-8512
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Active - Recruiting

  • Saitama Medical Center

    Saitama, 350-8550
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 160-8582
    Japan

    Active - Recruiting

  • The Jikei University Hospital

    Tokyo, 105-8471
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666
    Japan

    Active - Recruiting

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Mayo Clinic- Scottsdale

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • University of California Irvine - Manchester Pavilion

    Orange, California 92868
    United States

    Active - Recruiting

  • Stanford Neuroscience Health Center (SNHC)

    Palo Alto, California 94304
    United States

    Site Not Available

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

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • University of Florida College of Medicine Gainesville

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • University of Florida College of Medicine Gainesville; Neurology

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Nemours Children's Clinic - of the Nemours Foundation

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Consultants in Neurology Ltd

    Northbrook, Illinois 60062
    United States

    Active - Recruiting

  • Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital; Neurology

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan 48867
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • NYU Langone

    New York, New York 10003
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Medical Center; Dept. of Neurology

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati; Department of Neurology

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44915
    United States

    Active - Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Premier Neurology

    Greenville, South Carolina 29605
    United States

    Completed

  • Premier Neurology

    Greer, South Carolina 29650
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor College of Medicine; Neurology

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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