Multiple Sclerosis Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

152

Study ID:

NCT05271409

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 83 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
University of California Irvine - Manchester Pavilion
Orange California, 92868, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora Colorado, 80045, United States
Medstar Georgetown University Hospital
Washington District of Columbia, 20007, United States
University of Florida College of Medicine Gainesville; Neurology
Gainesville Florida, 32608, United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville Florida, 32207, United States
Northwestern University
Chicago Illinois, 60611, United States
Consultants in Neurology Ltd
Northbrook Illinois, 60062, United States
Johns Hopkins
Baltimore Maryland, 21287, United States
Massachusetts General Hospital; Neurology
Boston Massachusetts, 02114, United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso Michigan, 48867, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States
NYU Langone
New York New York, 10003, United States
Duke University Medical Center; Dept. of Neurology
Durham North Carolina, 27710, United States
University of Cincinnati; Department of Neurology
Cincinnati Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44915, United States
OhioHealth Research Institute
Columbus Ohio, 43214, United States
Premier Neurology
Greenville South Carolina, 29605, United States
Baylor College of Medicine; Neurology
Houston Texas, 77030, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Brain and Mind Research Institute
Camperdown New South Wales, 2050, Australia
John Hunter Hospital
New Lambton New South Wales, 2305, Australia
Sydney Children's Hospital
Randwick New South Wales, 2031, Australia
Royal North Shore Hospital; Department of Neurology
St Leonards New South Wales, 2065, Australia
Box Hill Hospital; Department of Neurology
Box Hill Victoria, 3128, Australia
Royal Melbourne Hospital; Department of Neurology
Parkville Victoria, 3050, Australia
Perron Institute for Neurological and Translational Science
Nedlands Western Australia, 6009, Australia
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro RJ, 20270, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre RS, 90610, Brazil
Centro de Pesquisas Clinicas; CPCLIN
Sao Paulo SP, 01228, Brazil
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Unity Health Toronto - St. Michael's Hospital
Toronto Ontario, M5B 1, Canada
The Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
MUCH - Montreal Neurological Institute & Hospital
Montreal Quebec, H3A 2, Canada
Peking Union Medical College Hospital
Beijing City , 10003, China
Beijing Children's Hospital, Capital Medical University
Beijing City , 10004, China
Beijing Tiantan Hospital,Capital Medical University
Beijing City , 10005, China
Xiangya Hospital Central South University
Changsha City , 41000, China
West China Hospital - Sichuan University
Chengdu City , 61004, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing , 40001, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou , 51063, China
Sir Run Run Shaw Hospital
Hangzhou City , 31001, China
Huashan Hospital Affiliated to Fudan University
Shanghai City , 20004, China
Children's Hospital of Fudan University
Shanghai , 20110, China
The First Hospital of Shanxi Medical University
Taiyuan , 03000, China
Tianjin Medical University General Hospital
Tianjin , 30005, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43003, China
Hopital Pierre Wertheimer; Neurologie D
Bron , 69677, France
APHP - Hopital de la Pitie Salpetriere
Paris , 75013, France
CHU de Toulouse - Hôpital Purpan
Toulouse , 31059, France
NeuroCure Clinical Research Center (NCRC); Clinical Neuroimmunology; Charitè Campus Mitte
Berlin , 10117, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum , 44791, Germany
Vestische Kinder- und Jugendklinik Datteln
Datteln , 45711, Germany
Universitätsklinikum Düsseldorf; Klinik für Neurologie
Düsseldorf , 40225, Germany
Neurology UKSH Campus Kiel
Kiel , 24105, Germany
Universitätsklinikum Mannheim; Neurologische Klinik
Mannheim , 68167, Germany
Klinikum Großhadern, LMU; Institut für klinische Neuroimmunologie
Munich , 81377, Germany
Hadassah University Hospital Ein Kerem; Neurology Department
Jerusalem , 91120, Israel
Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia
Roma Lazio, 00165, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano Lombardia, 20133, Italy
Fondazione Istituto Neurologico Mondino IRCCS
Pavia Lombardia, 27100, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano Piemonte, 10043, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania Sicilia, 95123, Italy
Azienda Ospedaliera Universitaria Integrata Verona; Neurologia B
Verona Veneto, 37134, Italy
Chiba University Hospital
Chiba , 260-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Southern Tohoku Medical Clinic
Fukushima , 963-8, Japan
Kobe University Hospital
Hyogo , 650-0, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi , 983-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Saitama Medical Center
Saitama , 350-8, Japan
The Jikei University Hospital
Tokyo , 105-8, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Tokyo Medical University Hospital
Tokyo , 160-0, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Tokyo Women's Medical University Hospital
Tokyo , 162-8, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

152

Study ID:

NCT05271409

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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