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

NCT05271409 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: WN431942021-003192-342023-507196-22-00
• Study Type: interventional
• Target: 152
• Locations: 11 countries
• Sites: 82

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 adolescent participants may be enrolled directly into the OLE period.

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Satralizumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Satralizumab DRUG

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.

Satralizumab

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Chugai Pharmaceutical: collaborator

Study Sites (82)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Mayo Clinic- Scottsdale

Scottsdale, Arizona, 85259, United States

WITHDRAWN

University of California Irvine - Manchester Pavilion

Irvine, California, 92697, United States

RECRUITING

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

Aurora, Colorado, 80045, United States

RECRUITING

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

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

WITHDRAWN

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

WITHDRAWN

Northwestern University

Chicago, Illinois, 60611, United States

WITHDRAWN

Consultants in Neurology Ltd

Northbrook, Illinois, 60062, United States

WITHDRAWN

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

Owosso, Michigan, 48867, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55902, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

NYU Langone

New York, New York, 10003, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

WITHDRAWN

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

Premier Neurology

Greenville, South Carolina, 29605, United States

COMPLETED

Baylor College of Medicine

Houston, Texas, 77030, United States

WITHDRAWN

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

COMPLETED

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

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

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, 6009, Australia

RECRUITING

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

Instituto do Cerebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Centro de Pesquisas Clinicas

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

Hospital Universitario Gaffree e Guinle

Rio de Janeiro, 20270-004, Brazil

RECRUITING

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

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

Ospedale Pediatrico Bambino Gesù

Rome, Lazio, 00165, Italy

WITHDRAWN

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

WITHDRAWN

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

WITHDRAWN

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

RECRUITING

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

Catania, Sicily, 95123, Italy

RECRUITING

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

ACTIVE NOT 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

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Interventions

satralizumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WN43194 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: August 30, 2022
• Primary Completion: November 20, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (4); FR (3); IT (7); AU (9); IL (1); PL (6); CA (5); DE (7); KR (3); JP (14); US (23)