A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
NCT ID: NCT04963270
Last Updated: 2025-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
188 participants
INTERVENTIONAL
2021-10-19
2024-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Satralizumab
Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.
Satralizumab
Satralizumab will be administered as a subcutaneous injection
Placebo
Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
Placebo
Satralizumab placebo will be administered as a subcutaneous injection
Interventions
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Satralizumab
Satralizumab will be administered as a subcutaneous injection
Placebo
Satralizumab placebo will be administered as a subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* For adolescent patients: Informed Consent Form for study participation signed by the parents 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 score attributed 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 the treatment period and for at least 3 months after the final dose of satralizumab.
Exclusion Criteria
* Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
* Known disease other than gMG that would interfere with the course and conduct of the study
* Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis 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 or within 3 months after the last dose
12 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Medical Faculty Associates Inc.
Washington D.C., District of Columbia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Prairie Education and Research
O'Fallon, Illinois, United States
Hospital Italiano
CABA, , Argentina
Hospital Ramos Mejía
CABA, , Argentina
Hospital Britanico
Ciudad Autonoma Bs As, , Argentina
Fundación Scherbovsky
Mendoza, , Argentina
INECO Neurociencias Orono
Rosario, , Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada
Beijing Tongren Hospital
Beijing, , China
Beijing Tiantan Hospital,Capital Medical University
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital - Sichuan University
Chengdu, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
The First Affiliated Hospital Of Shandong First Medical University
Jinan, , China
Huashan Hospital, Fudan University
Shanghai, , China
Children's Hospital of Fudan University
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Tangdu Hospital
Xi'an, , China
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet
København Ø, , Denmark
CHU Bordeaux
Bordeaux, , France
APHP Raymond Poincare
Garches, , France
Hopital Timone Adultes
Marseille, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
CHU Nice - Hôpital Pasteur 2
Nice, , France
St. Josef-Hospital, Klinik für Neurologie
Bochum, , Germany
Universitätsklinikum Essen (AöR)
Essen, , Germany
Universitätsklinikum Münster
Münster, , Germany
Azienda Ospedaliera A. Cardarelli
Napoli, Campania, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
A.R.N.A.S. Civico Di Cristina Benfratelli
Palermo, Sicily, Italy
Ospedale Cà Foncello
Treviso, Veneto, Italy
Juntendo University Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba-shi, Chiba, , Japan
General Hanamaki Hospital
Hanamaki, Iwate, , Japan
Sapporo Medical University Hospital
Hokkaido, , Japan
NHO Hokkaido Medical Center
Hokkaido, , Japan
St. Marianna University Hospital
Kanagawa, , Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba, , Japan
Kindai University Hospital
Osaka, , Japan
Seirei Hamamatsu General Hospital
Shizuoka, , Japan
Osaka University Hospital
Suita, , Japan
Tokyo Medical And Dental University, Medical Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Zespol Poradni Specjalistycznych - Poradnia Neurologiczna
Krakow, , Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, , Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, , Poland
Krasnoyarsk State Medical Academy
Krasnoyarsk, Krasnoyarsk Krai, Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Taipei Veterans General Hospital-Neurology
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan, , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Hospital
Kocaeli, , Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, , Turkey (Türkiye)
Countries
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References
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Habib AA, Zhao C, Aban I, Franca MC Jr, Jose JG, Zu Horste GM, Klimiec-Moskal E, Pulley MT, Tavolini D, Krumova P, Lennon-Chrimes S, Smith J, Thanei GA, Blondeau K, Vodopivec I, Wolfe GI, Murai H. Safety and efficacy of satralizumab in patients with generalised myasthenia gravis (LUMINESCE): a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2025 Feb;24(2):117-127. doi: 10.1016/S1474-4422(24)00514-3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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WN42636
Identifier Type: -
Identifier Source: org_study_id
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