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My Saved Trials

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Last Updated   May 6, 2025

Want to learn how to participate in this trial?

CR109046

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    111 Sites
  • Status
    Recruiting

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).

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 at screening
* Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 6 at screening and baseline
* Has sufficient venous access to allow drug administration by infusion and blood sampling 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 urine pregnancy test at Day 1 prior to administration of study intervention
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention


Exclusion Criteria:

* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency 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 'burnt out' MG)
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
* Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening


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

More...

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 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 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 Fuzhou Fujian Medical University Union Hospital
COMPLETED
China Guangzhou The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
RECRUITING
China Jinan Qianfoshan hospital of Shandong Province
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 Praha Vseobecna Fakultní Nemocnice
RECRUITING
Denmark Aalborg Aalborg University Hospital
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 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 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 Katowice NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
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 Valencia Hosp. Univ. I Politecni La Fe
RECRUITING
Sweden Karlstad Karlstad Central Hospital
COMPLETED
Sweden Stockholm Karolinska Universitetssjukhuset Solna
RECRUITING
Taiwan Taipei Shin Kong Wu Ho Su Memorial Hospital
RECRUITING
Taiwan Taipei Taipei Veterans General Hospital
RECRUITING
United States Boston St. Elizabeth Medical Center
COMPLETED
Belgium Brugge AZ Sint Jan Brugge Oostende AV
RECRUITING
China Changsha Xiangya Hospital Central South University
RECRUITING
China Chengdu West China Hospital of Sichuan University
COMPLETED
China Hangzhou Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
China Jinan Qilu Hospital of Shandong University
COMPLETED
Czechia Brno Fakultni nemocnice Brno
COMPLETED
Denmark København Ø Rigshospitalet
COMPLETED
Italy Catania U.O.P.I. di Psichiatria
COMPLETED
Italy Roma Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
COMPLETED
Japan Chiba Chiba University Hospital
COMPLETED
Japan Kita Gun Kagawa University Hospital
COMPLETED
Japan Kumamoto Kumamoto University Hospital
COMPLETED
Japan Sapporo Sapporo Medical University Hospital
COMPLETED
Japan Tokyo Tokyo Medical University Hospital
COMPLETED
Poland Bydgoszcz Neurocentrum Bydgoszcz Sp Z O O
RECRUITING
Poland Krakow Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
RECRUITING
Poland Lublin Prywatny Gabinet Lekarski
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
COMPLETED
Taiwan Taichung China Medical University Hospital
COMPLETED
Show More
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

42.50482, -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

-27.96724, 153.39796

50.83619, 4.31454

50.85045, 4.34878

51.05, 3.71667

50.87959, 4.70093

45.41117, -75.69812

43.70011, -79.4163

45.50884, -73.58781

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

43.88, 125.32278

26.06139, 119.30611

23.11667, 113.25

36.66833, 116.99722

31.22222, 121.45806

39.14222, 117.17667

34.25833, 108.92861

49.19522, 16.60796

50.08804, 14.42076

57.048, 9.9187

45.73333, 4.91667

45.16667, 5.71667

48.85341, 2.3488

43.6960355, 7.2655896

52.52437, 13.41053

51.53443, 9.93228

51.33962, 12.37129

53.86893, 10.68729

48.39841, 9.99155

50.08258, 8.24932

38.03856, 14.02285

45.46427, 9.18951

40.85216, 14.26811

45.19205, 9.15917

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

43.06667, 141.35

38.26667, 140.86667

34.06667, 134.56667

35.10278, 129.04028

35.87028, 128.59111

35.87028, 128.59111

37.566, 126.9784

21.88234, -102.28259

18.9261, -99.23075

20.66682, -103.39182

50.25841, 19.02754

52.22977, 21.01178

38.34517, -0.48149

41.38879, 2.15899

41.38879, 2.15899

41.38879, 2.15899

43.26271, -2.92528

37.38283, -5.97317

39.46975, -0.37739

59.3793, 13.50357

59.33258, 18.0649

25.04776, 121.53185

25.04776, 121.53185

42.35843, -71.05977

51.20892, 3.22424

28.19874, 112.97087

30.66667, 104.06667

30.29365, 120.16142

36.66833, 116.99722

49.19522, 16.60796

55.67594, 12.56553

37.49223, 15.07041

41.89193, 12.51133

35.6, 140.11667

34.2939708, 134.1237443

32.80589, 130.69182

43.06667, 141.35

35.6895, 139.69171

53.1235, 18.00762

50.06143, 19.93658

51.25, 22.56667

37.38283, -5.97317

24.1469, 120.6839

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