A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Last Updated August 15, 2024
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CR109046
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
SUMMARY
Myasthenia gravis (MG) is a rare, heterogeneous, neuromuscular disease characterized by fluctuating, fatigable muscle weakness. MG is caused by pathogenic autoantibodies that impair cholinergic transmission in the postsynaptic membrane at the neuromuscular junction and impair or prevent muscle contraction. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human, aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor (FcRn). This study will consist of a screening phase (up to 4 weeks), treatment phase (a 24-week double-blind placebo-controlled phase, and an open-label extension [OLE] phase [up to 2 years]) and a follow-up safety visit (up to 8 weeks after last infusion of study intervention). Efficacy evaluations will include assessments such as Myasthenia Gravis - Activities of Daily Living (MG-ADL) score. Safety evaluations (such as adverse events, physical examination, vital signs, electrocardiogram [ECG], and clinical laboratory tests) will be performed. The overall duration of study will be up to 4 years and 8 months.
CONDITIONS
- Myasthenia Gravis
ELIGIBILITY
Inclusion Criteria:
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b a
DETAILS
LOCATIONS
Locations in:
United States, Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, South Korea, Mexico, Poland, Spain, Sweden, Taiwan
| Country (17) | City or Province (111) | Status |
| United States | Paradise Valley Neuromuscular Research Center and Clinic |
RECRUITING
|
| United States | Scottsdale HonorHealth Neurology |
COMPLETED
|
| United States | Los Angeles University of Southern California |
COMPLETED
|
| United States | Palo Alto Stanford University |
COMPLETED
|
| United States | Pasadena Care Access Research |
RECRUITING
|
| United States | Aurora University of Colorado Anschutz Medical Campus |
RECRUITING
|
| United States | New Haven Yale New Haven Hospital |
RECRUITING
|
| United States | Boca Raton FM Clinical Research, LLC South Florida Neurology Associates, P. A. |
RECRUITING
|
| United States | Jacksonville University of Florida Health Jacksonville |
COMPLETED
|
| United States | Port Charlotte Medsol Clinical Research Center Inc |
RECRUITING
|
| United States | Tampa University of South Florida |
RECRUITING
|
| United States | Augusta Augusta University |
COMPLETED
|
| United States | Kansas City University of Kansas Medical Center |
RECRUITING
|
| United States | Boston St. Elizabeth Medical Center |
RECRUITING
|
| United States | Burlington Lahey Hospital & Medical Center |
COMPLETED
|
| United States | Saint Louis Washington University School Of Medicine |
COMPLETED
|
| United States | Durham Duke University School of Medicine |
RECRUITING
|
| United States | Cincinnati University of Cincinnati |
COMPLETED
|
| United States | Cleveland Cleveland Clinic |
RECRUITING
|
| United States | Columbus The Ohio State University |
RECRUITING
|
| United States | Charleston Medical University of South Carolina |
RECRUITING
|
| United States | Cordova Wesley Neurology |
COMPLETED
|
| United States | Dallas UT Southwestern Medical Center |
COMPLETED
|
| United States | Burlington University of Vermont |
COMPLETED
|
| Australia | North Melbourne Melbourne Neurology Group |
COMPLETED
|
| Australia | Southport Gold Coast University Hospital |
RECRUITING
|
| Belgium | Anderlecht ULB Hôpital Erasme |
RECRUITING
|
| Belgium | Brugge AZ Sint-Jan Brugge-Oostende AV |
RECRUITING
|
| Belgium | Brussels Cliniques Universitaires Saint Luc |
RECRUITING
|
| Belgium | Gent AZ Sint-Lucas |
RECRUITING
|
| Belgium | Leuven University Hospitals Leuven |
RECRUITING
|
| Canada | Ottawa The Ottawa Hospital Research Institute |
RECRUITING
|
| Canada | Toronto Toronto General Hospital |
RECRUITING
|
| Canada | Montreal McGill University |
COMPLETED
|
| China | Beijing Beijing Tiantan Hospital, Capital Medical University |
RECRUITING
|
| China | Beijing Xuanwu Hospital ,Capital Medical University |
COMPLETED
|
| China | Beijing Beijing Hospital |
RECRUITING
|
| China | Changchun The First Bethune Hospital of Jilin University |
RECRUITING
|
| China | Changsha Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College |
RECRUITING
|
| China | Chengdu West China Hospital of Sichuan University |
RECRUITING
|
| China | Fuzhou Fujian Medical University Union Hospital |
COMPLETED
|
| China | Guangzhou The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine |
RECRUITING
|
| China | Hangzhou Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
RECRUITING
|
| China | Jinan Qianfoshan hospital of Shandong Province |
RECRUITING
|
| China | Jinan Qilu Hospital of Shandong University |
RECRUITING
|
| China | Shanghai Huashan Hospital Fudan University |
RECRUITING
|
| China | Tianjin Tianjin Medical University General Hospital |
RECRUITING
|
| China | Xi'An The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital |
RECRUITING
|
| Czechia | Brno Neurologie a rehabilitace Skopalíkova |
RECRUITING
|
| Czechia | Brno Fakultni nemocnice Brno |
RECRUITING
|
| Czechia | Praha Vseobecna Fakultní Nemocnice |
RECRUITING
|
| Denmark | Aalborg Aalborg University Hospital |
RECRUITING
|
| Denmark | København Ø Rigshospitalet |
RECRUITING
|
| France | Bron Hopital Pierre Wertheimer |
RECRUITING
|
| France | Grenoble CHU Grenoble |
RECRUITING
|
| France | Paris Hopital de la Pitie Salpetriere |
RECRUITING
|
| France | Provence-Alpes-Côte d'Azur Hopital PASTEUR |
RECRUITING
|
| Germany | Berlin NeuroCure Clinical Research Center |
RECRUITING
|
| Germany | Göttingen Universitatsmedizin Gottingen |
RECRUITING
|
| Germany | Leipzig Universitaetsklinikum Leipzig |
COMPLETED
|
| Germany | Lübeck Universitatsklinikum Schleswig Holstein Campus Lubeck |
COMPLETED
|
| Germany | Ulm Universitatsklinikum Ulm |
RECRUITING
|
| Germany | Wiesbaden DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie |
COMPLETED
|
| Italy | Catania U.O.P.I. di Psichiatria |
RECRUITING
|
| Italy | Cefalu Fondazione Istituto G. Giglio |
RECRUITING
|
| Italy | Milano Istituto Neurologico Carlo Besta |
RECRUITING
|
| Italy | Napoli Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli |
RECRUITING
|
| Italy | Pavia IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione |
RECRUITING
|
| Italy | Roma Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza |
RECRUITING
|
| Italy | Roma Policlinico Universitario Agostino Gemelli |
RECRUITING
|
| Japan | Hanamaki General Hanamaki Hospital |
RECRUITING
|
| Japan | Hiroshima shi Hiroshima University Hospital |
RECRUITING
|
| Japan | Itabashi Ku Teikyo University Hospital |
RECRUITING
|
| Japan | Kawasaki Shi St Marianna University Hospital |
RECRUITING
|
| Japan | Morioka-shi Iwate Medical University Hospital |
RECRUITING
|
| Japan | Nagoya-shi National Hospital Organization Nagoya Medical Center |
RECRUITING
|
| Japan | Niigata Niigata City General Hospital |
RECRUITING
|
| Japan | Nishinomiya-Shi Hyogo College of Medicine Hospital |
RECRUITING
|
| Japan | Sapporo Hokkaido Medical Center |
RECRUITING
|
| Japan | Sendai-City National Hospital Organization Sendai Medical Center |
RECRUITING
|
| Japan | Tokushima Tokushima University Hospital |
RECRUITING
|
| South Korea | Busan Pusan National University Hospital |
RECRUITING
|
| South Korea | Daegu Kyungpook National University Chilgok Hospital |
RECRUITING
|
| South Korea | Daegu Kyungpook National University Hospital |
COMPLETED
|
| South Korea | Seoul Severance Hospital Yonsei University Health System |
RECRUITING
|
| Mexico | Aguascalientes iBiomed Research Unit |
COMPLETED
|
| Mexico | Cuernavaca Consultorio Dr. Miguel Cortes |
RECRUITING
|
| Mexico | Guadalajara Hospital Civil de Guadalajara Fray Antonio Alcalde |
RECRUITING
|
| Poland | Bydgoszcz Neurocentrum Bydgoszcz Sp Z O O |
RECRUITING
|
| Poland | Katowice NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis' |
RECRUITING
|
| Poland | Krakow Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii |
RECRUITING
|
| Poland | Lublin Prywatny Gabinet Lekarski |
RECRUITING
|
| Poland | Warsaw Centrum Medyczne NeuroProtect |
RECRUITING
|
| Spain | Alicante Hosp. Gral. Univ. de Alicante |
RECRUITING
|
| Spain | Barcelona Hosp. de La Santa Creu I Sant Pau |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | Barcelona Hosp Clinic de Barcelona |
RECRUITING
|
| Spain | Bilbao Hosp. Univ. de Basurto |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Macarena |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
|
| Spain | Valencia Hosp. Univ. I Politecni La Fe |
RECRUITING
|
| Sweden | Karlstad Karlstad Central Hospital |
COMPLETED
|
| Sweden | Stockholm Karolinska Universitetssjukhuset Solna |
RECRUITING
|
| Taiwan | Taichung China Medical University Hospital |
RECRUITING
|
| Taiwan | Taipei Shin Kong Wu Ho Su Memorial Hospital |
RECRUITING
|
| Taiwan | Taipei Taipei Veterans General Hospital |
RECRUITING
|
| Japan | Chiba Chiba University Hospital |
TERMINATED
|
| Japan | Kita-Gun Kagawa University Hospital |
TERMINATED
|
| Japan | Kumamoto Kumamoto University Hospital |
TERMINATED
|
| Japan | Sapporo Sapporo Medical University Hospital |
TERMINATED
|
| Japan | Tokyo Tokyo Medical University Hospital |
TERMINATED
|
Geo Locations
33.53115, -111.94265
33.50921, -111.89903
34.05223, -118.24368
37.44188, -122.14302
34.14778, -118.14452
39.72943, -104.83192
41.30815, -72.92816
26.3669, -80.13033
30.33218, -81.65565
26.97617, -82.09064
27.94752, -82.45843
33.47097, -81.97484
39.11417, -94.62746
42.35843, -71.05977
42.50482, -71.19561
38.62727, -90.19789
35.99403, -78.89862
39.12713, -84.51435
41.4995, -81.69541
39.96118, -82.99879
32.77657, -79.93092
35.15565, -89.7762
32.78306, -96.80667
44.47588, -73.21207
-37.80132, 144.95822
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39.9075, 116.39723
39.9075, 116.39723
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43.88, 125.32278
28.19874, 112.97087
30.66667, 104.06667
26.06139, 119.30611
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37.49223, 15.07041
38.03856, 14.02285
45.46427, 9.18951
40.85216, 14.26811
45.19205, 9.15917
41.89193, 12.51133
41.89193, 12.51133
39.38333, 141.11667
34.4, 132.45
35.74893, 139.71497
35.52056, 139.71722
39.7, 141.15
35.18147, 136.90641
37.88637, 139.00589
34.71562, 135.33199
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35.10278, 129.04028
35.87028, 128.59111
35.87028, 128.59111
37.566, 126.9784
21.88234, -102.28259
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20.66682, -103.39182
53.1235, 18.00762
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51.25, 22.56667
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38.34517, -0.48149
41.38879, 2.15899
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41.38879, 2.15899
43.26271, -2.92528
37.38283, -5.97317
37.38283, -5.97317
39.46975, -0.37739
59.3793, 13.50357
59.33258, 18.0649
24.1469, 120.6839
25.04776, 121.53185
25.04776, 121.53185
35.6, 140.11667
34.2939708, 134.1237442
32.80589, 130.69182
43.06667, 141.35
35.6895, 139.69171
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