A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

November 17, 2023

Study Completion Date

April 17, 2026

Conditions
Myasthenia Gravis
Interventions
DRUG

Nipocalimab

Nipocalimab will be administered as an IV infusion.

DRUG

Placebo

Matching placebo will be administered as an IV infusion.

DRUG

Nipocalimab SC-LIV

Nipocalimab will be administered subcutaneously.

Trial Locations (111)

111

Shin Kong Wu Ho Su Memorial Hospital, Taipei

168

Policlinico Universitario Agostino Gemelli, Roma

1070

ULB Hôpital Erasme, Anderlecht

1200

Cliniques Universitaires Saint Luc, Brussels

2100

Rigshospitalet, København Ø

3000

University Hospitals Leuven, Leuven

3051

Melbourne Neurology Group, North Melbourne

4215

Gold Coast University Hospital, Southport

8000

AZ Sint Jan Brugge Oostende AV, Bruges

8036

Hosp Clinic de Barcelona, Barcelona

9000

AZ Sint-Lucas, Ghent

Aalborg University Hospital, Aalborg

10117

NeuroCure Clinical Research Center, Berlin

11217

Taipei Veterans General Hospital, Taipei

12808

Vseobecna Fakultní Nemocnice, Prague

20010

iBiomed Research Unit, Aguascalientes

20133

Istituto Neurologico Carlo Besta, Milan

23538

Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck

27100

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione, Pavia

27710

Duke University School of Medicine, Durham

29425

Medical University of South Carolina, Charleston

32209

University of Florida Health Jacksonville, Jacksonville

33487

FM Clinical Research, LLC South Florida Neurology Associates, P. A., Boca Raton

33612

University of South Florida, Tampa

33952

Medsol Clinical Research Center Inc, Port Charlotte

37075

Universitatsmedizin Gottingen, Göttingen

38018

Wesley Neurology, Cordova

38043

CHU Grenoble, Grenoble

40447

China Medical University Hospital, Taichung

41009

Hosp. Virgen Macarena, Seville

41013

Hosp. Virgen Del Rocio, Seville

41404

Kyungpook National University Chilgok Hospital, Daegu

41944

Kyungpook National University Hospital, Daegu

43210

The Ohio State University, Columbus

44145

Cleveland Clinic, Cleveland

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

45219

University of Cincinnati, Cincinnati

46026

Hosp. Univ. I Politecni La Fe, Valencia

48013

Hosp. Univ. de Basurto, Bilbao

49241

Pusan National University Hospital, Busan

62448

Consultorio Dr. Miguel Cortes, Cuernavaca

63110

Washington University School Of Medicine, St Louis

65191

DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie, Wiesbaden

66160

University of Kansas Medical Center, Kansas City

69500

Hopital Pierre Wertheimer, Bron

75013

Hopital de la Pitie Salpetriere, Paris

75390

UT Southwestern Medical Center, Dallas

80045

University of Colorado Anschutz Medical Campus, Aurora

80138

Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli, Napoli

85028

Neuromuscular Research Center and Clinic, Paradise Valley

85251

HonorHealth Neurology, Scottsdale

89081

Universitatsklinikum Ulm, Ulm

90015

Fondazione Istituto G. Giglio, Cefalù

90033

University of Southern California, Los Angeles

91101

Care Access Research, Pasadena

94304

Stanford University, Palo Alto

95100

U.O.P.I. di Psichiatria, Catania

100050

Beijing Tiantan Hospital, Capital Medical University, Beijing

100053

Xuanwu Hospital ,Capital Medical University, Beijing

100730

Beijing Hospital, Beijing

130021

The First Bethune Hospital of Jilin University, Changchun

200040

Huashan Hospital Fudan University, Shanghai

250014

Qianfoshan hospital of Shandong Province, Jinan

Qilu Hospital of Shandong University, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

310020

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

350001

Fujian Medical University Union Hospital, Fuzhou

410008

Xiangya Hospital Central South University, Changsha

510405

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

710038

The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital, Xi'an

06519

Yale New Haven Hospital, New Haven

30912-3125

Augusta University, Augusta

02135

St. Elizabeth Medical Center, Boston

01805

Lahey Hospital & Medical Center, Burlington

05401

University of Vermont, Burlington

K1Y 4E9

The Ottawa Hospital Research Institute, Ottawa

M5G 2C4

Toronto General Hospital, Toronto

H3A 2B4

McGill University, Montreal

615 00

Neurologie a rehabilitace Skopalíkova, Brno

625 00

Fakultni nemocnice Brno, Brno

06000

Hopital PASTEUR, Provence-Alpes-Côte d'Azur

04103

Universitaetsklinikum Leipzig, Leipzig

00189

Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza, Roma

260 8677

Chiba University Hospital, Chiba

025-0082

General Hanamaki Hospital, Hanamaki

734 8551

Hiroshima University Hospital, Hiroshima

173 8606

Teikyo University Hospital, Itabashi Ku

216 8511

St Marianna University Hospital, Kawasaki Shi

761 0793

Kagawa University Hospital, Kita Gun

860-8556

Kumamoto University Hospital, Kumamoto

020-8505

Iwate Medical University Hospital, Morioka

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

950-1197

Niigata City General Hospital, Niigata

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-Shi

0608556

Sapporo Medical University Hospital, Sapporo

063 0005

Hokkaido Medical Center, Sapporo

983-8520

National Hospital Organization Sendai Medical Center, Sendai

770-8503

Tokushima University Hospital, Tokushima

160-0023

Tokyo Medical University Hospital, Tokyo

85 796

Neurocentrum Bydgoszcz Sp Z O O, Bydgoszcz

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis', Katowice

31 505

Centrum Neurologii Klinicznej Krakowska Akademia Neurologii, Krakow

20 093

Prywatny Gabinet Lekarski, Lublin

01-684

Centrum Medyczne NeuroProtect, Warsaw

120-752

Severance Hospital Yonsei University Health System, Seoul

03010

Hosp. Gral. Univ. de Alicante, Alicante

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08035

Hosp Univ Vall D Hebron, Barcelona

651 85

Karlstad Central Hospital, Karlstad

171 76

Karolinska Universitetssjukhuset Solna, Stockholm

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY