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Clinical Trials in Australia / NCT05271409
Active, not recruiting Phase 3

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

NCT05271409 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2022-08-30
Last updated
2026-09-04

Condition(s) studied

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Investigational drug(s) / intervention(s)

Satralizumab →Placebo

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: 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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of California Irvine - Manchester Pavilion Irvine California
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) Aurora Colorado
Medstar Georgetown University Hospital Washington D.C. District of Columbia
University of Florida College of Medicine Gainesville Gainesville Florida
Johns Hopkins Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis Owosso Michigan
Mayo Clinic - Rochester Rochester Minnesota
Washington University School of Medicine in St. Louis St Louis Missouri
NYU Langone New York New York
University of Cincinnati Cincinnati Ohio
Cleveland Clinic Foundation Cleveland Ohio
Premier Neurology Greenville South Carolina
Medical College of Wisconsin Milwaukee Wisconsin
Brain and Mind Research Institute Camperdown New South Wales
Monash Medical Centre Clayton Victoria
Perron Institute for Neurological and Translational Science Nedlands Western Australia
Instituto de Neurologia de Curitiba Curitiba Paraná
Instituto do Cerebro do Rio Grande do Sul Porto Alegre Rio Grande do Sul
Centro de Pesquisas Clinicas São Paulo São Paulo
Hospital Universitario Gaffree e Guinle Rio de Janeiro Brazil
Children's Hospital of Eastern Ontario Ottawa Ontario
MUCH - Montreal Neurological Institute & Hospital Montreal Quebec
Hopital Pierre Wertheimer Bron France
CH de Bicêtre Le Kremlin-Bicêtre France
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Berlin Germany
St. Josef-Hospital, Klinik für Neurologie Bochum Germany
Vestische Kinder- und Jugendklinik Datteln Datteln Germany
Universitätsklinikum Düsseldorf Düsseldorf Germany
Universitätsklinikum Mannheim Mannheim Germany
Klinikum Großhadern, LMU Munich Germany
Hadassah University Hospital Ein Kerem Jerusalem Israel
Fondazione Istituto Neurologico Mondino IRCCS Pavia Lombardy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga Orbassano Piedmont
Azienda Ospedaliera Universitaria Integrata Verona Verona Veneto
Chiba University Hospital Chiba Japan
Kyushu University Hospital Fukuoka Japan
Southern Tohoku Medical Clinic Fukushima Japan
Kobe University Hospital Hyōgo Japan

+ 13 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05271409 on ClinicalTrials.gov ↗ ← All trials in Australia