A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Last updated: February 24, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Myasthenia Gravis Generalised

Sarcopenia

Treatment

Satralizumab

Placebo

Clinical Study ID

NCT04963270
WN42636
  • Ages > 12
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed Informed Consent Form

  • For adolescent patients: Informed Consent Form for study participation signed by theparents or a legal guardian, and patient assent obtained, as per local requirements

  • Ability to comply with the study protocol procedures

  • Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)

  • A total MG-ADL score of ≥ 5 points at screening with more than 50% of this scoreattributed to non-ocular items

  • MGFA severity Class II-IV

  • Ongoing gMG treatment at a stable dose

  • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during thetreatment period and for at least 3 months after the final dose of satralizumab.

Exclusion

Exclusion Criteria:

  • History of thymectomy within 12 months prior to screening

  • Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3months prior to screening

  • Known disease other than gMG that would interfere with the course and conduct of thestudy

  • Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)

  • Evidence of latent or active tuberculosis (excluding patients receivingchemoprophylaxis for latent tuberculosis infection)

  • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline

  • Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 3 months after the last dose

Study Design

Total Participants: 188
Treatment Group(s): 2
Primary Treatment: Satralizumab
Phase: 3
Study Start date:
October 19, 2021
Estimated Completion Date:
September 02, 2024

Connect with a study center

  • Hospital Italiano

    Caba, C1199ABA
    Argentina

    Site Not Available

  • Hospital Italiano; Neurology

    Caba, C1199ABA
    Argentina

    Site Not Available

  • Hospital Ramos Mejía

    Caba, C1221ADC
    Argentina

    Site Not Available

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB
    Argentina

    Site Not Available

  • Fundación Scherbovsky

    Mendoza, M5500AYB
    Argentina

    Site Not Available

  • Fundación Scherbovsky; General Department

    Mendoza, M5500AYB
    Argentina

    Site Not Available

  • INECO Neurociencias Orono

    Rosario, S2000DTC
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

    San Miguel, T4000AXL
    Argentina

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Box Hill Hospital; Department of Neurology

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Instituto de Neurologia de Curitiba

    Curitiba, PR 81210-310
    Brazil

    Site Not Available

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo 13083-887
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC - FMABC

    Santo Andre, São Paulo 09060-650
    Brazil

    Site Not Available

  • Hospital Sao Paulo

    Sao Paulo, São Paulo 04037-002
    Brazil

    Site Not Available

  • University of Calgary; Heritage Medical Research Clinic

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, DUMMY_VALUE
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing City, 100050
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun City, 130021
    China

    Site Not Available

  • Hunan Children's Hospital

    Changsha City, 410007
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha City, 410008
    China

    Site Not Available

  • West China Hospital - Sichuan University

    Chengdu City, 610047
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, DUMMY_VALUE
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang City, 550000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou City, 310018
    China

    Site Not Available

  • The First Affiliated Hospital Of Shandong First Medical University

    Jinan, DUMMY_VALUE
    China

    Site Not Available

  • The First Affiliated Hospital Of Shandong First Medical University

    Jinan City, 250014
    China

    Site Not Available

  • Children's Hospital of Fudan University

    Shanghai, 201102
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai City, 200040
    China

    Site Not Available

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou City, 325035
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Site Not Available

  • Tangdu Hospital

    Xi'an,
    China

    Site Not Available

  • Tangdu Hospital

    Xi'an City, 710038
    China

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Aarhus Universitetshospital; Neurologisk Klinik

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Rigshospitalet

    København Ø, 2100
    Denmark

    Site Not Available

  • Rigshospitalet; Klinik for Nerve- og Muskelsygdomme

    København Ø, 2100
    Denmark

    Site Not Available

  • CHU Bordeaux

    Bordeaux cedex, 33076
    France

    Site Not Available

  • APHP Raymond Poincare

    Garches, 92380
    France

    Site Not Available

  • Hopital Timone Adultes

    Marseille, 13385
    France

    Site Not Available

  • Hopital Timone Adultes; Neurologie Mal Neuro Musculaires

    Marseille, 13385
    France

    Site Not Available

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU Nice - Hôpital Pasteur 2

    Nice, 06000
    France

    Site Not Available

  • CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE

    Nice, 06000
    France

    Site Not Available

  • Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • CHU Bordeaux

    Pessac, 33604
    France

    Site Not Available

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791
    Germany

    Site Not Available

  • Universitätsklinikum Essen (AöR)

    Essen, 45147
    Germany

    Site Not Available

  • Universitätsklinikum Essen (AöR); Klinik für Neurologie

    Essen, 45147
    Germany

    Site Not Available

  • Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

    Münster, 48149
    Germany

    Site Not Available

  • Azienda Ospedaliera A. Cardarelli

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico

    Napoli, Campania 80131
    Italy

    Site Not Available

  • A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

    Roma, Lazio 00189
    Italy

    Site Not Available

  • Fond. Istituto Neurologico C.Besta

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • A.R.N.A.S. Civico Di Cristina Benfratelli

    Palermo, Sicilia 90127
    Italy

    Site Not Available

  • A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit

    Palermo, Sicilia 90127
    Italy

    Site Not Available

  • Ospedale Cà Foncello

    Treviso, Veneto 31100
    Italy

    Site Not Available

  • Ospedale Cà Foncello; S.C Neurologia

    Treviso, Veneto 31100
    Italy

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • Juntendo University Hospital; Neurology

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba-shi, Chiba, 260-8677
    Japan

    Site Not Available

  • Chiba University Hospital; Neurology

    Chiba-shi, Chiba, 260-8677
    Japan

    Site Not Available

  • General Hanamaki Hospital

    Hanamaki, Iwate, 025-0082
    Japan

    Site Not Available

  • General Hanamaki Hospital; Neurology

    Hanamaki, Iwate, 025-0082
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • NHO Hokkaido Medical Center

    Hokkaido, 063-0005
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543
    Japan

    Site Not Available

  • Sapporo Medical University Hospital; Neurology

    Hokkaido, 060-8543
    Japan

    Site Not Available

  • Kagawa University Hospital; Neurology

    Kagawa, 761-0793
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • Saitama Medical Center; Neurology

    Kawagoe-shi, Saitama, 350-8550
    Japan

    Site Not Available

  • Nagasaki Kawatana Medical Center; Neurology

    Nagasaki, 859-3615
    Japan

    Site Not Available

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba, 286-0124
    Japan

    Site Not Available

  • International University of Health and Welfare Narita Hospital; Neurology

    Narita, Chiba, 286-0124
    Japan

    Site Not Available

  • Kindai University Hospital

    Osaka, 589-8511
    Japan

    Site Not Available

  • Kindai University Hospital; Neurology

    Osaka, 589-8511
    Japan

    Site Not Available

  • Osaka Toneyama Medical Center; Neurology

    Osaka,
    Japan

    Site Not Available

  • Dokkyo Medical University Saitama Medical Center; Neurology

    Saitama, 343-8555
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital; Neurology

    Shinjuku-ku, 162-8666
    Japan

    Site Not Available

  • Seirei Hamamatsu General Hospital

    Shizuoka, 430-8558
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, 565-0871
    Japan

    Site Not Available

  • Osaka University Hospital; Neurology

    Suita, 565-0871
    Japan

    Site Not Available

  • Tokyo Medical And Dental University, Medical Hospital

    Tokyo, 113-8519
    Japan

    Site Not Available

  • Tokyo Medical And Dental University, Medical Hospital; Neurology

    Tokyo, 113-8519
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, (0)6351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC Location AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • LUMC

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-952
    Poland

    Site Not Available

  • Klinika Neurologii Dorosłych, Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80-952
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych - Poradnia Neurologiczna

    Kraków, 31-503
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie

    Kraków, 31-503
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-016
    Poland

    Site Not Available

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnojarsk 660037
    Russian Federation

    Site Not Available

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnojarsk 660022
    Russian Federation

    Site Not Available

  • National Center of Social Significant Disease

    Sankt-peterburg, Leningrad 197110
    Russian Federation

    Site Not Available

  • Research Center of Neurology; Neurology Department #5

    Moskva, Moskovskaja Oblast 125367
    Russian Federation

    Site Not Available

  • Leningrad Regional Clinical Hospital

    St Petersburg, Sankt Petersburg 194291
    Russian Federation

    Site Not Available

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Samara Regional Clinical Hospital named after V.D. Seredavina

    Samara, 443095
    Russian Federation

    Site Not Available

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge; Servicio de Neurologia

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital de Donostia Unidad Demencias; Consultas de Neurología

    San Sebastian, Guipuzcoa 20080
    Spain

    Site Not Available

  • Hospital Universitario Infanta Sofia; Servicio de Neurologia

    San Sebastian de los Reyes, Madrid 28702
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra; Servicio de Neurología

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

    Barcelona, 08041
    Spain

    Site Not Available

  • Clinica Universitaria Navarra; Servicio Neurologia

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario la Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario la Fe; Servicio de Neurologia

    Valencia, 46026
    Spain

    Site Not Available

  • Taipei Veterans General Hospital-Neurology

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Hacettepe University Medical Faculty

    Ankara, 06100
    Turkey

    Site Not Available

  • Hacettepe University Medical Faculty; Neurology

    Ankara, 06100
    Turkey

    Site Not Available

  • Ege University Medical Faculty

    Izmir, 35100
    Turkey

    Site Not Available

  • Kocaeli University Hospital

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Kocaeli University Hospital; Department of Neurology

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139
    Turkey

    Site Not Available

  • Ondokuz Mayis Univ. Med. Fac.; Neurology

    Samsun, 55139
    Turkey

    Site Not Available

  • Karadeniz Tecnical Uni. Med. Fac.; Neurology

    Trabzon, 61080
    Turkey

    Site Not Available

  • HonorHealth Neurology

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California Irvine - Manchester Pavilion

    Orange, California 92868
    United States

    Site Not Available

  • SC3 Research Group, Inc

    Pasadena, California 91105
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital; Department of Pediatrics

    San Francisco, California 94143
    United States

    Site Not Available

  • Childrens National Health Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medical Faculty Associates Inc.

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • University of Florida Jacksonville Physicians Inc. (UFJPI)

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Chicago Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Prairie Education and Research

    O'Fallon, Illinois 62269
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics; Department of Neurology

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114-2621
    United States

    Site Not Available

  • Washington University School of Medicine; Department of Neurology

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University at Buffalo / SUNY; UBMD Neurology

    Buffalo, New York 14203
    United States

    Site Not Available

  • Neurological Institute of New York

    New York, New York 10032
    United States

    Site Not Available

  • South Shore Neurologic Associates P.C.

    Patchogue, New York 11772
    United States

    Site Not Available

  • NeuroScience Research Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center; Department of Neurology

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Mercy Neurology Clinic

    Moore, Oklahoma 73160
    United States

    Site Not Available

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