A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Start Date
7/15/2021
Completion Date
3/29/2029
Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Nipocalimab
Placebo
Nipocalimab SC-LIV
Conditions
Locations
Neuromuscular Research Center and Clinic
Paradise Valley, Arizona 85028
United States
HonorHealth Neurology
Scottsdale, Arizona 85251
United States
University of Southern California
Los Angeles, California 90033
United States
Stanford University
Palo Alto, California 94304
United States
Care Access Research
Pasadena, California 91101
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Yale New Haven Hospital
New Haven, Connecticut 06519
United States
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida 33487
United States
University of Florida Health Jacksonville
Jacksonville, Florida 32209
United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida 33952
United States
University of South Florida
Tampa, Florida 33612
United States
Augusta University
Augusta, Georgia 30912-3125
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
St. Elizabeth Medical Center
Boston, Massachusetts 02135
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
Washington University School Of Medicine
St Louis, Missouri 63110
United States
Duke University School of Medicine
Durham, North Carolina 27710
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Cleveland Clinic
Cleveland, Ohio 44145
United States
The Ohio State University
Columbus, Ohio 43210
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Wesley Neurology
Cordova, Tennessee 38018
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
University of Vermont
Burlington, Vermont 05401
United States
Melbourne Neurology Group
North Melbourne, 3051
Australia
Gold Coast University Hospital
Southport, 4215
Australia
ULB Hôpital Erasme
Anderlecht, 1070
Belgium
AZ Sint Jan Brugge Oostende AV
Bruges, 8000
Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200
Belgium
AZ Sint-Lucas
Ghent, 9000
Belgium
University Hospitals Leuven
Leuven, 3000
Belgium
The Ottawa Hospital Research Institute
Ottawa, Ontario K1Y 4E9
Canada
Toronto General Hospital
Toronto, Ontario M5G 2C4
Canada
McGill University
Montreal, Quebec H3A 2B4
Canada
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
China
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
China
Beijing Hospital
Beijing, 100730
China
The First Bethune Hospital of Jilin University
Changchun, 130021
China
Xiangya Hospital Central South University
Changsha, 410008
China
West China Hospital of Sichuan University
Chengdu, 610041
China
Fujian Medical University Union Hospital
Fuzhou, 350001
China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, 510405
China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310020
China
Qianfoshan hospital of Shandong Province
Jinan, 250014
China
Qilu Hospital of Shandong University
Jinan, 250014
China
Huashan Hospital Fudan University
Shanghai, 200040
China
Tianjin Medical University General Hospital
Tianjin, 300052
China
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, 710038
China
Neurologie a rehabilitace Skopalíkova
Brno, 615 00
Czechia
Fakultni nemocnice Brno
Brno, 625 00
Czechia
Vseobecna Fakultní Nemocnice
Prague, 12808
Czechia
Aalborg University Hospital
Aalborg, 9000
Denmark
Rigshospitalet
København Ø, 2100
Denmark
Hopital Pierre Wertheimer
Bron, 69500
France
CHU Grenoble
Grenoble, 38043
France
Hopital de la Pitie Salpetriere
Paris, 75013
France
Hopital Pasteur 1
Provence-Alpes-Côte d'Azur, 06000
France
Hopital PASTEUR
Provence-Alpes-Côte d'Azur, 06000
France
NeuroCure Clinical Research Center
Berlin, 10117
Germany
Universitatsmedizin Gottingen
Göttingen, 37075
Germany
Universitaetsklinikum Leipzig
Leipzig, 04103
Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, 23538
Germany
Universitatsklinikum Ulm
Ulm, 89081
Germany
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
Wiesbaden, 65191
Germany
U.O.P.I. di Psichiatria
Catania, 95100
Italy
Fondazione Istituto G. Giglio
Cefalù, 90015
Italy
Istituto Neurologico Carlo Besta
Milan, 20133
Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, 80138
Italy
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, 27100
Italy
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
Roma, 00189
Italy
Policlinico Universitario Agostino Gemelli
Roma, 168
Italy
Chiba University Hospital
Chiba, 260 8677
Japan
General Hanamaki Hospital
Hanamaki, 025-0082
Japan
Hiroshima University Hospital
Hiroshima, 734 8551
Japan
Teikyo University Hospital
Itabashi Ku, 173 8606
Japan
St Marianna University Hospital
Kawasaki Shi, 216 8511
Japan
Kagawa University Hospital
Kita Gun, 761 0793
Japan
Kumamoto University Hospital
Kumamoto, 860-8556
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
Japan
Niigata City General Hospital
Niigata, 950-1197
Japan
Hyogo College of Medicine Hospital
Nishinomiya-Shi, 663-8501
Japan
Sapporo Medical University Hospital
Sapporo, 0608556
Japan
Hokkaido Medical Center
Sapporo, 063 0005
Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695
Japan
Tokushima University Hospital
Tokushima, 770-8503
Japan
Tokyo Medical University Hospital
Tokyo, 160-0023
Japan
iBiomed Research Unit
Aguascalientes, 20010
Mexico
Consultorio Dr. Miguel Cortes
Cuernavaca, 62448
Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
Mexico
Neurocentrum Bydgoszcz Sp Z O O
Bydgoszcz, 85 796
Poland
Neurologia Slaska Centrum Medyczne
Katowice, 40-689
Poland
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
Krakow, 31 505
Poland
Prywatny Gabinet Lekarski
Lublin, 20 093
Poland
Centrum Medyczne NeuroProtect
Warsaw, 01-684
Poland
Pusan National University Hospital
Busan, 49241
South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
Kyungpook National University Hospital
Daegu, 41944
South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-752
South Korea
Hosp. Gral. Univ. de Alicante
Alicante, 03010
Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
Spain
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp Clinic de Barcelona
Barcelona, 8036
Spain
Hosp. Univ. de Basurto
Bilbao, 48013
Spain
Hosp. Virgen Macarena
Seville, 41009
Spain
Hosp. Virgen Del Rocio
Seville, 41013
Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Spain
Karlstad Central Hospital
Karlstad, 651 85
Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Sweden
China Medical University Hospital
Taichung, 40447
Taiwan
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan