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Brief Title: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Study ID: NCT04963270
Brief Summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
Detailed Description:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Neurology, Scottsdale, Arizona, United States
Keck School of Medicine of USC, Los Angeles, California, United States
University of California Irvine - Manchester Pavilion, Orange, California, United States
SC3 Research Group, Inc, Pasadena, California, United States
UCSF Benioff Children's Hospital; Department of Pediatrics, San Francisco, California, United States
Childrens National Health Center, Washington, District of Columbia, United States
Medical Faculty Associates Inc., Washington, District of Columbia, United States
University of Florida Jacksonville Physicians Inc. (UFJPI), Jacksonville, Florida, United States
University of Chicago Hospital, Chicago, Illinois, United States
Prairie Education and Research, O'Fallon, Illinois, United States
University of Iowa Hospitals & Clinics; Department of Neurology, Iowa City, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Washington University School of Medicine; Department of Neurology, Saint Louis, Missouri, United States
University at Buffalo / SUNY; UBMD Neurology, Buffalo, New York, United States
South Shore Neurologic Associates P.C., Patchogue, New York, United States
NeuroScience Research Center, Canton, Ohio, United States
The Ohio State University Wexner Medical Center; Department of Neurology, Columbus, Ohio, United States
Hospital Italiano; Neurology, Caba, , Argentina
Hospital Ramos Mejía, Caba, , Argentina
Hospital Britanico, Ciudad Autonoma Bs As, , Argentina
Fundación Scherbovsky; General Department, Mendoza, , Argentina
INECO Neurociencias Orono, Rosario, , Argentina
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY, San Miguel, , Argentina
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Box Hill Hospital; Department of Neurology, Box Hill, Victoria, Australia
Instituto de Neurologia de Curitiba, Curitiba, PR, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital das Clinicas - UNICAMP, Campinas, SP, Brazil
Faculdade de Medicina do ABC - FMABC, Santo Andre, SP, Brazil
Hospital Sao Paulo, Sao Paulo, SP, Brazil
MUCH - Montreal Neurological Institute & Hospital, Montreal, Quebec, Canada
Beijing Tiantan Hospital,Capital Medical University, Beijing City, , China
Beijing Tongren Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Hunan Children's Hospital, Changsha City, , China
Xiangya Hospital Central South University, Changsha City, , China
West China Hospital - Sichuan University, Chengdu City, , China
The Affiliated Hospital of Guizhou Medical University, Guiyang City, , China
Sir Run Run Shaw Hospital, Hangzhou City, , China
The First Affiliated Hospital Of Shandong First Medical University, Jinan City, , China
Huashan Hospital, Fudan University, Shanghai City, , China
Children's Hospital of Fudan University, Shanghai, , China
Tianjin Medical University General Hospital, Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou City, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Tangdu Hospital, Xi'an City, , China
Aarhus Universitetshospital; Neurologisk Klinik, Aarhus N, , Denmark
Rigshospitalet; Klinik for Nerve- og Muskelsygdomme, København Ø, , Denmark
APHP Raymond Poincare, Garches, , France
Hopital Timone Adultes; Neurologie Mal Neuro Musculaires, Marseille, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE, Nice, , France
Hopital de la Pitie Salpetriere, Paris, , France
CHU Bordeaux, Pessac, , France
St. Josef-Hospital, Klinik für Neurologie, Bochum, , Germany
Universitätsklinikum Essen (AöR); Klinik für Neurologie, Essen, , Germany
Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie, Leipzig, , Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie, Münster, , Germany
Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico, Napoli, Campania, Italy
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS), Roma, Lazio, Italy
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari, Milano, Lombardia, Italy
Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione, Pavia, Lombardia, Italy
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit, Palermo, Sicilia, Italy
Ospedale Cà Foncello; S.C Neurologia, Treviso, Veneto, Italy
Juntendo University Hospital; Neurology, Bunkyo-ku, , Japan
Chiba University Hospital; Neurology, Chiba-shi, Chiba, , Japan
General Hanamaki Hospital; Neurology, Hanamaki, Iwate, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Sapporo Medical University Hospital; Neurology, Hokkaido, , Japan
NHO Hokkaido Medical Center, Hokkaido, , Japan
Kagawa University Hospital; Neurology, Kagawa, , Japan
St. Marianna University Hospital, Kanagawa, , Japan
Saitama Medical Center; Neurology, Kawagoe-shi, Saitama, , Japan
Nagasaki Kawatana Medical Center; Neurology, Nagasaki, , Japan
International University of Health and Welfare Narita Hospital; Neurology, Narita, Chiba, , Japan
Kindai University Hospital; Neurology, Osaka, , Japan
Osaka Toneyama Medical Center; Neurology, Osaka, , Japan
Dokkyo Medical University Saitama Medical Center; Neurology, Saitama, , Japan
Tokyo Women's Medical University Hospital; Neurology, Shinjuku-ku, , Japan
Seirei Hamamatsu General Hospital, Shizuoka, , Japan
Osaka University Hospital; Neurology, Suita, , Japan
Tokyo Medical And Dental University, Medical Hospital; Neurology, Tokyo, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Amsterdam UMC Location AMC, Amsterdam, , Netherlands
LUMC, Leiden, , Netherlands
Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne, Gda?sk, , Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K, Krakow, , Poland
Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie, Kraków, , Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak., Lublin, , Poland
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk, Krasnojarsk, Russian Federation
Krasnoyarsk State Medical Academy, Krasnoyarsk, Krasnojarsk, Russian Federation
National Center of Social Significant Disease, Sankt-peterburg, Leningrad, Russian Federation
Research Center of Neurology; Neurology Department #5, Moskva, Moskovskaja Oblast, Russian Federation
Leningrad Regional Clinical Hospital, St Petersburg, Sankt Petersburg, Russian Federation
Novosibirsk State Regional Clinical Hospital, Novosibirsk, , Russian Federation
Samara Regional Clinical Hospital named after V.D. Seredavina, Samara, , Russian Federation
Hospital Universitari de Bellvitge; Servicio de Neurologia, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Donostia Unidad Demencias; Consultas de Neurología, San Sebastian, Guipuzcoa, Spain
Hospital Universitario Infanta Sofia; Servicio de Neurologia, San Sebastian de los Reyes, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Neurología, Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia, Madrid, , Spain
Clinica Universitaria Navarra; Servicio Neurologia, Madrid, , Spain
Hospital Universitario la Fe; Servicio de Neurologia, Valencia, , Spain
Taipei Veterans General Hospital-Neurology, Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Branch, Taoyuan City, , Taiwan
Hacettepe University Medical Faculty; Neurology, Ankara, , Turkey
Ege University Medical Faculty, Izmir, , Turkey
Kocaeli University Hospital; Department of Neurology, Kocaeli, , Turkey
Ondokuz Mayis Univ. Med. Fac.; Neurology, Samsun, , Turkey
Karadeniz Tecnical Uni. Med. Fac.; Neurology, Trabzon, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR