Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Sarcopenia
Treatment
Nipocalimab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting theclinical criteria for generalized myasthenia gravis (gMG) as defined by theMyasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b,III a/b, or IVa/b at screening
Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than orequal to (>=) 6 at screening and baseline
Has sufficient venous access to allow drug administration by infusion and bloodsampling as per the protocol
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urinepregnancy test at Day 1 prior to administration of study intervention
A male participant must agree not to donate sperm for the purpose of reproductionduring the study and for a minimum 90 days after receiving the last administrationof study intervention
Exclusion
Exclusion Criteria:
Has any confirmed or suspected clinical immunodeficiency syndrome not related totreatment of his/her gMG, or has a family history of congenital or hereditaryimmunodeficiency unless confirmed absent in the participant
Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening,history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burntout' MG)
Has had a thymectomy within 12 months prior to screening, or thymectomy is plannedduring the study
Has known allergies, hypersensitivity, or intolerance to nipocalimab or itsexcipients
Has experienced myocardial infarction, unstable ischemic heart disease, or strokewithin 12 weeks of screening
Study Design
Connect with a study center
Townsville Hospital
Douglas, Queensland
AustraliaSite Not Available
Melbourne Neurology Group
North Melbourne, 3051
AustraliaCompleted
Gold Coast University Hospital
Southport, 4215
AustraliaActive - Recruiting
ULB Hôpital Erasme
Anderlecht, 1070
BelgiumActive - Recruiting
AZ Sint Jan Brugge Oostende AV
Brugge, 8000
BelgiumActive - Recruiting
AZ Sint-Jan Brugge-Oostende AV
Brugge, 8000
BelgiumActive - Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
BelgiumActive - Recruiting
AZ Sint-Lucas
Gent, 9000
BelgiumActive - Recruiting
University Hospitals Leuven
Leuven, 3000
BelgiumActive - Recruiting
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
The Ottawa Hospital Research Institute
Ottawa, Ontario K1Y 4E9
CanadaActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
McGill University
Montreal, Quebec H3A 2B4
CanadaCompleted
Beijing Hospital
Beijing, 100730
ChinaActive - Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
ChinaActive - Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
ChinaCompleted
Xuanwu Hospital, Capital Medical University
Beijing, 100053
ChinaActive - Recruiting
The First Bethune Hospital of Jilin University
Changchun, 130021
ChinaActive - Recruiting
Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College
Changsha, 410008
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, 410008
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, 610041
ChinaCompleted
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaCompleted
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, 510405
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310020
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310020
ChinaActive - Recruiting
Qianfoshan hospital of Shandong Province
Jinan, 250014
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan, 250014
ChinaCompleted
Huashan Hospital Fudan University
Shanghai, 200040
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaActive - Recruiting
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'An, 710038
ChinaActive - Recruiting
Medicity S.A.S
Bucaramanga, 681012
ColombiaSite Not Available
Fundacion Cardiovascular de Colombia
Floridablanca, 680004
ColombiaSite Not Available
Fakultni nemocnice Brno
Brno, 625 00
CzechiaCompleted
Neurologie a rehabilitace Skopalíkova
Brno, 615 00
CzechiaActive - Recruiting
Fakultni nemocnice Ostrava
Ostrava, 70852
CzechiaSite Not Available
Vseobecna Fakultní Nemocnice
Praha, 12808
CzechiaActive - Recruiting
Aalborg University Hospital
Aalborg, 9000
DenmarkActive - Recruiting
Aarhus Universitetshospital
Aarhus, DK-8200
DenmarkSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkCompleted
Hopital Pierre Wertheimer
Bron, 69500
FranceActive - Recruiting
CHU Grenoble
Grenoble, 38043
FranceCompleted
Hopital de la Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
Hopital PASTEUR
Provence-Alpes-Côte d'Azur, 06000
FranceActive - Recruiting
NeuroCure Clinical Research Center
Berlin, 10117
GermanyActive - Recruiting
Kreiskrankenhaus Gummersbach
Gummersbach, 51643
GermanySite Not Available
Universitatsmedizin Gottingen
Göttingen, 37075
GermanyActive - Recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
GermanyActive - Recruiting
Universitätsklinikum Jena
Jena, 07747
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanyCompleted
Universitatsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, 23538
GermanyCompleted
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lübeck, 23538
GermanyActive - Recruiting
Klinikum rechts der Isar der TU Munchen
München, 81675
GermanySite Not Available
Universitatsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
Wiesbaden, 65191
GermanyCompleted
U.O.P.I. di Psichiatria
Catania, 95100
ItalyCompleted
Fondazione Istituto G. Giglio
Cefalu, 90015
ItalyActive - Recruiting
Istituto Neurologico Carlo Besta
Milano, 20133
ItalyActive - Recruiting
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, 80138
ItalyActive - Recruiting
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, 27100
ItalyActive - Recruiting
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
Roma, 00189
ItalyCompleted
Policlinico Universitario Agostino Gemelli
Roma, 168
ItalyActive - Recruiting
Chiba University Hospital
Chiba, 260 8677
JapanCompleted
General Hanamaki Hospital
Hanamaki, 025-0082
JapanActive - Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
JapanSite Not Available
Hiroshima University Hospital
Hiroshima shi, 734 8551
JapanActive - Recruiting
Hiroshima University Hospital
Hiroshima-shi, 734-8551
JapanSite Not Available
Teikyo University Hospital
Itabashi Ku, 173 8606
JapanActive - Recruiting
Teikyo University Hospital
Itabashi-Ku, 173-8606
JapanSite Not Available
St Marianna University Hospital
Kawasaki Shi, 216 8511
JapanActive - Recruiting
St.Marianna University Hospital
Kawasaki-Shi, 216-8511
JapanSite Not Available
Kagawa University Hospital
Kita Gun, 761 0793
JapanCompleted
Kagawa University Hospital
Kita-Gun, 761-0793
JapanSite Not Available
Kumamoto University Hospital
Kumamoto, 860-8556
JapanCompleted
Iwate Medical University Hospital
Morioka-shi, 020-8505
JapanActive - Recruiting
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
JapanSite Not Available
National Hospital Organization Nagoya Medical Center
Nagoya-shi, 460-0001
JapanActive - Recruiting
Niigata City General Hospital
Niigata, 950-1197
JapanActive - Recruiting
Hyogo College of Medicine Hospital
Nishinomiya-Shi, 663-8501
JapanActive - Recruiting
Kindai University Hospital
Osaka-Sayama, 589-8511
JapanSite Not Available
Kindai University Hospital
Osaka-Sayama-shi, 589-8511
JapanSite Not Available
Hokkaido Medical Center
Sapporo, 063 0005
JapanActive - Recruiting
Sapporo Medical University Hospital
Sapporo, 0608556
JapanCompleted
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
JapanSite Not Available
National Hospital Organization Sendai Medical Center
Sendai-City, 983-8520
JapanActive - Recruiting
Tokushima University Hospital
Tokushima, 770-8503
JapanActive - Recruiting
Teikyo University Hospital
Tokyo, 173-8606
JapanActive - Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanCompleted
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofCompleted
Severance Hospital, Yonsei University Health System
Seodaemun, 120-752
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 120-752
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Korea, Republic ofActive - Recruiting
Pusan National University Yangsan Hospital
Yangsan-si, 50612
Korea, Republic ofSite Not Available
iBiomed Research Unit
Aguascalientes, 20010
MexicoCompleted
Consultorio Dr. Miguel Cortes
Cuernavaca, 62448
MexicoActive - Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
MexicoActive - Recruiting
Neurocentrum Bydgoszcz Sp Z O O
Bydgoszcz, 85 796
PolandActive - Recruiting
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
Katowice, 40-123
PolandActive - Recruiting
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
Krakow, 31 505
PolandActive - Recruiting
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
Krakow, 31-505
PolandActive - Recruiting
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324
PolandSite Not Available
Prywatny Gabinet Lekarski
Lublin, 20 093
PolandActive - Recruiting
Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznań, 60-848
PolandSite Not Available
Centrum Medyczne NeuroProtect
Warsaw, 01-684
PolandActive - Recruiting
Regional State Budgetary Healthcare Organization 'Regional Clinical Hospital'
Barnaul, 656024
Russian FederationSite Not Available
Research Medical Center Your Health
Kazan, 420097
Russian FederationSite Not Available
Kemerovo Region Clinical Hospital
Kemerovo, 650066
Russian FederationSite Not Available
Chaika Health - Clinic Chaika
Moscow, 123112
Russian FederationSite Not Available
Regional Clinical Hospital n.a.Semashko
Nizhniy Novgorod, 603126
Russian FederationSite Not Available
Novosibirsk Region Clinical Hospital
Novosibirsk, 630087
Russian FederationSite Not Available
Institute of Human Brain Ras
St. Petersburg, 197376
Russian FederationSite Not Available
Hosp. Gral. Univ. de Alicante
Alicante, 03010
SpainActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hosp. de la Santa Creu i Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hosp. Univ. de Basurto
Bilbao, 48013
SpainActive - Recruiting
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hosp. Virgen Del Rocio
Sevilla, 41013
SpainCompleted
Hosp. Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainActive - Recruiting
Karlstad Central Hospital
Karlstad, 651 85
SwedenCompleted
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
SwedenActive - Recruiting
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung, 833
TaiwanSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanCompleted
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Bezmialem University Medical Faculty
Fatih, 34093
TurkeySite Not Available
Istanbul Universitesi Istanbul Tip Fakültesi
Istanbul, 34098
TurkeySite Not Available
Selçuk Üniversitesi Tıp Fakültesi Hastanesi
Konya, 42130
TurkeySite Not Available
Mersin Universitesi Tip Fakultesi
Mersin, 33079
TurkeySite Not Available
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
TurkeySite Not Available
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomSite Not Available
St George's Hospital
London, SW17 0QT
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United KingdomSite Not Available
IMC-Diagnostic and Medical Clinic
Mobile, Alabama 36604
United StatesSite Not Available
Neuromuscular Research Center and Clinic
Paradise Valley, Arizona 85028
United StatesActive - Recruiting
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesCompleted
University of Southern California
Los Angeles, California 90033
United StatesCompleted
Stanford University
Palo Alto, California 94304
United StatesCompleted
Care Access Research
Pasadena, California 91101
United StatesActive - Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven, Connecticut 06519
United StatesActive - Recruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida 33487
United StatesActive - Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida 32209
United StatesCompleted
Medsol Clinical Research Center Inc
Port Charlotte, Florida 33952
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
Augusta University
Augusta, Georgia 30912-3125
United StatesCompleted
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
St. Elizabeth Medical Center
Boston, Massachusetts 02135
United StatesCompleted
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United StatesCompleted
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesCompleted
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Las Vegas Medical Research
Las Vegas, Nevada 89145
United StatesSite Not Available
Atrium Health
Charlotte, North Carolina 28078
United StatesSite Not Available
Duke University School of Medicine
Durham, North Carolina 27710
United StatesActive - Recruiting
University of Cincinnati
Cincinnati, Ohio 45219
United StatesCompleted
Cleveland Clinic
Cleveland, Ohio 44145
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Wesley Neurology
Cordova, Tennessee 38018
United StatesCompleted
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesCompleted
University of Vermont
Burlington, Vermont 05401
United StatesCompleted
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