Actively Recruiting
Led by Janssen Research & Development, LLC · Updated on 2026-03-03
199
Participants Needed
112
Research Sites
280 weeks
Total Duration
Researchers are evaluating the effectiveness and safety of nipocalimab compared to a placebo in adults with generalized myasthenia gravis (gMG), a condition causing muscle weakness. The study also includes a sub-study to compare how nipocalimab works when given as a subcutaneous injection versus an intravenous infusion. This is a Phase 3, randomized, double-blind, placebo-controlled trial sponsored by Janssen Research & Development, LLC. Participants receive nipocalimab through intravenous infusions every two weeks for up to 24 weeks during the double-blind phase. Those who complete this phase may enter an open-label extension (OLE) to continue receiving nipocalimab either by intravenous infusion every two weeks or by subcutaneous injection once weekly for up to 8 weeks, with an option to continue the subcutaneous treatment in a long-term extension period. During the study, participants will be monitored through various assessments including the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score, Quantitative Myasthenia Gravis (QMG) score, and patient-reported quality of life scales. Researchers will also track safety measures such as adverse events, vital signs, and laboratory values over the entire study period, which may last up to nearly five years. The study will measure changes from baseline in these scores at multiple points to evaluate the drug's impact and safety.
CONDITIONS
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive nipocalimab or placebo intravenous (IV) infusions once every 2 weeks up to 24 weeks during the double-blind placebo-controlled phase.
Infusions every 2 weeks during treatment
Duration - Up to 8 weeks for subcutaneous substudy; longer for open-label extension
Participants in the open-label extension phase may continue receiving nipocalimab IV infusions every 2 weeks or receive nipocalimab subcutaneous liquid (SC-LIV) once weekly for 8 weeks in the subcutaneous substudy.
Weekly visits for up to 8 weeks for subcutaneous substudy; biweekly visits for IV infusions in open-label extension
Duration - Until study end (up to approximately 4 years 9 months)
Participants who complete the subcutaneous substudy may continue receiving nipocalimab SC-LIV weekly in a long-term extension period for ongoing monitoring and treatment.
Weekly visits continuing in long-term extension
Total: 112 locations
1
Neuromuscular Research Center and Clinic
Paradise Valley, Arizona, United States, 85028
Actively Recruiting
2
HonorHealth Neurology
Scottsdale, Arizona, United States, 85251
Completed
3
University of Southern California
Los Angeles, California, United States, 90033
Completed
4
Stanford University
Palo Alto, California, United States, 94304
Completed
5
Care Access Research
Pasadena, California, United States, 91101
Actively Recruiting
6
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
8
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida, United States, 33487
Actively Recruiting
9
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32209
Completed
10
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States, 33952
Actively Recruiting
11
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
12
Augusta University
Augusta, Georgia, United States, 30912-3125
Completed
13
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
14
St. Elizabeth Medical Center
Boston, Massachusetts, United States, 02135
Completed
15
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Completed
16
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Completed
17
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Actively Recruiting
18
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Completed
19
Cleveland Clinic
Cleveland, Ohio, United States, 44145
Actively Recruiting
20
The Ohio State University
Columbus, Ohio, United States, 43210
Completed
21
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
Wesley Neurology
Cordova, Tennessee, United States, 38018
Completed
23
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Completed
24
University of Vermont
Burlington, Vermont, United States, 05401
Completed
25
Melbourne Neurology Group
North Melbourne, Australia, 3051
Completed
26
Gold Coast University Hospital
Southport, Australia, 4215
Actively Recruiting
27
ULB Hôpital Erasme
Anderlecht, Belgium, 1070
Actively Recruiting
28
AZ Sint Jan Brugge Oostende AV
Bruges, Belgium, 8000
Actively Recruiting
29
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
30
AZ Sint-Lucas
Ghent, Belgium, 9000
Actively Recruiting
31
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
32
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Actively Recruiting
33
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
34
McGill University
Montreal, Quebec, Canada, H3A 2B4
Completed
35
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
36
Xuanwu Hospital ,Capital Medical University
Beijing, China, 100053
Completed
37
Beijing Hospital
Beijing, China, 100730
Actively Recruiting
38
The First Bethune Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
39
Xiangya Hospital Central South University
Changsha, China, 410008
Actively Recruiting
40
West China Hospital of Sichuan University
Chengdu, China, 610041
Completed
41
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Completed
42
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, China, 510405
Actively Recruiting
43
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China, 310020
Completed
44
Qianfoshan hospital of Shandong Province
Jinan, China, 250014
Actively Recruiting
45
Qilu Hospital of Shandong University
Jinan, China, 250014
Completed
46
Huashan Hospital Fudan University
Shanghai, China, 200040
Actively Recruiting
47
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
48
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, China, 710038
Actively Recruiting
49
Neurologie a rehabilitace Skopalíkova
Brno, Czechia, 615 00
Actively Recruiting
50
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Completed
51
Vseobecna Fakultní Nemocnice
Prague, Czechia, 12808
Actively Recruiting
52
Aalborg University Hospital
Aalborg, Denmark, 9000
Completed
53
Rigshospitalet
København Ø, Denmark, 2100
Completed
54
Hopital Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
55
CHU Grenoble
Grenoble, France, 38043
Completed
56
Hopital de la Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
57
Hopital PASTEUR
Provence-Alpes-Côte d'Azur, France, 06000
Actively Recruiting
58
Hopital PASTEUR
Provence-Alpes-Côte d'Azur, France, 06000
Completed
59
NeuroCure Clinical Research Center
Berlin, Germany, 10117
Actively Recruiting
60
Universitatsmedizin Gottingen
Göttingen, Germany, 37075
Completed
61
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Completed
62
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, Germany, 23538
Completed
63
Universitatsklinikum Ulm
Ulm, Germany, 89081
Completed
64
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
Wiesbaden, Germany, 65191
Completed
65
U.O.P.I. di Psichiatria
Catania, Italy, 95100
Completed
66
Fondazione Istituto G. Giglio
Cefalù, Italy, 90015
Actively Recruiting
67
Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
68
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, Italy, 80138
Actively Recruiting
69
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy, 27100
Actively Recruiting
70
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
Roma, Italy, 00189
Completed
71
Policlinico Universitario Agostino Gemelli
Roma, Italy, 168
Actively Recruiting
72
Chiba University Hospital
Chiba, Japan, 260 8677
Completed
73
General Hanamaki Hospital
Hanamaki, Japan, 025-0082
Actively Recruiting
74
Hiroshima University Hospital
Hiroshima, Japan, 734 8551
Actively Recruiting
75
Teikyo University Hospital
Itabashi Ku, Japan, 173 8606
Actively Recruiting
76
St Marianna University Hospital
Kawasaki Shi, Japan, 216 8511
Actively Recruiting
77
Kagawa University Hospital
Kita Gun, Japan, 761 0793
Completed
78
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Completed
79
Iwate Medical University Hospital
Morioka, Japan, 020-8505
Actively Recruiting
80
National Hospital Organization Nagoya Medical Center
Nagoya, Japan, 460-0001
Completed
81
Niigata City General Hospital
Niigata, Japan, 950-1197
Actively Recruiting
82
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Japan, 663-8501
Actively Recruiting
83
Sapporo Medical University Hospital
Sapporo, Japan, 0608556
Completed
84
Hokkaido Medical Center
Sapporo, Japan, 063 0005
Actively Recruiting
85
National Hospital Organization Sendai Medical Center
Sendai, Japan, 983-8520
Actively Recruiting
86
Tokushima University Hospital
Tokushima, Japan, 770-8503
Completed
87
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Completed
88
iBiomed Research Unit
Aguascalientes, Mexico, 20010
Completed
89
Consultorio Dr. Miguel Cortes
Cuernavaca, Mexico, 62448
Actively Recruiting
90
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico, 44280
Actively Recruiting
91
Neurocentrum Bydgoszcz Sp Z O O
Bydgoszcz, Poland, 85 796
Actively Recruiting
92
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
Katowice, Poland, 40-123
Actively Recruiting
93
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
Krakow, Poland, 31 505
Actively Recruiting
94
Prywatny Gabinet Lekarski
Lublin, Poland, 20 093
Actively Recruiting
95
Centrum Medyczne NeuroProtect
Warsaw, Poland, 01-684
Actively Recruiting
96
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
97
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
98
Kyungpook National University Hospital
Daegu, South Korea, 41944
Completed
99
Severance Hospital Yonsei University Health System
Seoul, South Korea, 120-752
Actively Recruiting
100
Hosp. Gral. Univ. de Alicante
Alicante, Spain, 03010
Actively Recruiting
101
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
102
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
103
Hosp Clinic de Barcelona
Barcelona, Spain, 8036
Actively Recruiting
104
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Actively Recruiting
105
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
106
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Completed
107
Hosp. Univ. I Politecni La Fe
Valencia, Spain, 46026
Actively Recruiting
108
Karlstad Central Hospital
Karlstad, Sweden, 651 85
Completed
109
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
Actively Recruiting
110
China Medical University Hospital
Taichung, Taiwan, 40447
Completed
111
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
112
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
S
Study Contact
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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