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

NCT05271409 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: WN431942021-003192-342023-507196-22-00
• Study Type: interventional
• Target: 152
• Locations: 11 countries
• Sites: 53

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 (53)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California Irvine - Manchester Pavilion

Irvine, California, 92697, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Medstar Georgetown University Hospital

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

Location

University of Florida College of Medicine Gainesville

Gainesville, Florida, 32608, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

Owosso, Michigan, 48867, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55902, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

NYU Langone

New York, New York, 10003, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44915, United States

Location

Premier Neurology

Greenville, South Carolina, 29605, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Brain and Mind Research Institute

Camperdown, New South Wales, 2050, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, 6009, Australia

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Instituto do Cerebro do Rio Grande do Sul

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

Location

Centro de Pesquisas Clinicas

São Paulo, São Paulo, 01228-200, Brazil

Location

Hospital Universitario Gaffree e Guinle

Rio de Janeiro, 20270-004, Brazil

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MUCH - Montreal Neurological Institute & Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Hopital Pierre Wertheimer

Bron, 69677, France

Location

CH de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

Berlin, 13125, Germany

Location

St. Josef-Hospital, Klinik für Neurologie

Bochum, 44791, Germany

Location

Vestische Kinder- und Jugendklinik Datteln

Datteln, 45711, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Klinikum Großhadern, LMU

Munich, 81377, Germany

Location

Hadassah University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, 27100, Italy

Location

Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, 37134, Italy

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Southern Tohoku Medical Clinic

Fukushima, 963-8052, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Kitasato University Hospital

Kanagawa, 252-0375, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

The University of Osaka Hospital

Osaka, 565-0871, Japan

Location

The Jikei University Hospital

Tokyo, 105-8471, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, 40-123, Poland

Location

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

Warsaw, 02-097, Poland

Location

SPSK nr 1

Zabrze, 41-800, Poland

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

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): May 20, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (4); FR (2); IT (3); AU (3); IL (1); US (15); KR (3); PL (3); CA (2); DE (6); JP (11)