152
Participants
Start Date
September 27, 2022
Primary Completion Date
December 16, 2026
Study Completion Date
December 14, 2029
Satralizumab
In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight. 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. In Part 2, participants will be asked to choose from one of the following options: Option 1: continue on randomized, double-blind study drug; Option 2: start open-label satralizumab based on body weight; Option 3: stop study treatment and continue follow-up assessments.
Placebo
Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 once it becomes available at the study site.
RECRUITING
Chang Gung Memorial Hospital - Linkou, Taoyuan
WITHDRAWN
Medizinische Universität Wien, Vienna
RECRUITING
Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz
RECRUITING
Odense Universitetshospital, Neurologisk Afdeling N, Odense C
RECRUITING
NYU-Langone Medical Center, New York
RECRUITING
Irccs A.O.U.San Martino Ist, Genoa
RECRUITING
Univ of Pennsylvania Med Ctr, Philadelphia
RECRUITING
IRCCS Ospedale San Raffaele, Milan
RECRUITING
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan
RECRUITING
University of Maryland Medical Center, Baltimore
RECRUITING
Johns Hopkins Hospital, Baltimore
RECRUITING
Fondazione Istituto Neurologico Mondino IRCCS, Pavia
RECRUITING
Hospital General Universitario Gregorio Marañon, Madrid
RECRUITING
Hospital Regional Universitario de Malaga ? Hospital General, Málaga
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
CHRU - Hôpital Bretonneau, Tours
RECRUITING
China Medical University Hospital, North Dist.
RECRUITING
CHU Saint Etienne - Hôpital Nord, Saint-Etienne
RECRUITING
University Hospitals of Cleveland, Cleveland
RECRUITING
Cleveland Clinic Foundation, Cleveland
RECRUITING
University of Iowa Hospitals & Clinics, Iowa City
RECRUITING
Medical College of Wisconsin, Milwaukee
RECRUITING
Mayo Clinic - Rochester, Rochester
ACTIVE_NOT_RECRUITING
Hopital neurologique Pierre Wertheimer - CHU Lyon, Bron
RECRUITING
Hopital Pitié Salpétrière - CHU, Paris
RECRUITING
University of Texas at Houston, Houston
RECRUITING
University of Colorado, Aurora
RECRUITING
A. O. U. Federico II, Napoli
RECRUITING
AOU Seconda Università degli Studi, Napoli
RECRUITING
AOU Policlinico Giaccone, Palermo
RECRUITING
UC San Diego, La Jolla
RECRUITING
Hoag Memorial Hospital, Newport Beach
RECRUITING
UCSF- Multiple Sclerosis Centre, San Francisco
WITHDRAWN
Swedish Neuroscience Institute, Seattle
RECRUITING
Beijing Children's Hospital, Capital Medical University, Beijing
RECRUITING
Beijing Tongren Hospital, Beijing
RECRUITING
National University Hospital (NUH), Singapore
RECRUITING
The First Hospital of Jilin University, Changchun
RECRUITING
Huashan Hospital, Fudan University, Shanghai
RECRUITING
Affiliated Hospital of Jining Medical University, Jining
ACTIVE_NOT_RECRUITING
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou
RECRUITING
Fujian Medical University Union Hospital, Fuzhou
RECRUITING
The Second Xiangya Hospital of Central South University, Changsha
RECRUITING
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
RECRUITING
Guangzhou First Municipal People's Hospital, Guangzhou
RECRUITING
West China Hospital - Sichuan University, Chengdu
RECRUITING
Hyogo prefectural Kobe Children's Hospital, Hyogoken
RECRUITING
Brigham and Women's Hospital Department of Neurology, Boston
ACTIVE_NOT_RECRUITING
Hospital Ramos Mejía, CABA
RECRUITING
Hospital Britanico, Ciudad Autonoma Bs As
RECRUITING
Sanatorio del Sur S.A., San Miguel de Tucumán
RECRUITING
Hospital Geral de Fortaleza, Fortaleza
RECRUITING
CEDOES - Diagnóstico e Pesquisa, Vitória
RECRUITING
Instituto de Neurologia de Curitiba, Curitiba
ACTIVE_NOT_RECRUITING
Centro de Pesquisas Clinicas, São Paulo
RECRUITING
Hospital Israelita Albert Einstein, São Paulo
RECRUITING
Beijing Tiantan Hospital,Capital Medical University, Beijing
RECRUITING
Komfo Anokye Teaching Hospital, Kumasi
RECRUITING
The First Hospital of Shanxi Medical University, Taiyuan
RECRUITING
Fakultni nemocnice Hradec Kralove, Hradec Králové
RECRUITING
Fakultni nemocnice v Motole, Prague
WITHDRAWN
Ospedale Pediatrico Bambino Gesù, Rome
RECRUITING
Fujita Health University Hospital, Aichi
ACTIVE_NOT_RECRUITING
Chiba University Hospital, Chiba
ACTIVE_NOT_RECRUITING
Kyushu University Hospital, Fukuoka
RECRUITING
Fukuoka University Hospital, Fukuoka
ACTIVE_NOT_RECRUITING
Gifu University Hospital, Gifu
ACTIVE_NOT_RECRUITING
Hokkaido University Hospital, Hokkaido
RECRUITING
Kobe University Hospital, Hyōgo
RECRUITING
Kagoshima City Hospital, Kagoshima
COMPLETED
St.Marianna University School of Medicine hospital, Kanagawa
ACTIVE_NOT_RECRUITING
Kitasato University Hospital, Kanagawa
RECRUITING
Tokai University Hospital, Kanagawa
RECRUITING
Tohoku University Hospital, Miyagi
RECRUITING
The University of Osaka Hospital, Osaka
RECRUITING
Kindai University Hospital, Ōsaka-sayama
RECRUITING
Ageo Central General Hospital, Saitama
RECRUITING
Juntendo University Hospital, Tokyo
ACTIVE_NOT_RECRUITING
Nihon University Itabashi Hospital, Tokyo
RECRUITING
Erasmus MC, Rotterdam
WITHDRAWN
Regionalny Szpital Specjalistyczny im. W. Bieganskiego, Grudzi?dz
COMPLETED
Szpital Uniwersytecki w Krakowie, Krakow
RECRUITING
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw
RECRUITING
SPSK nr 1, Zabrze
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Hospital Alvaro Cunqueiro, Vigo
RECRUITING
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City
Collaborators (1)
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY