Spots Global Cancer Trial Database for A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Official Title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Study ID: NCT04951622
Conditions
Study Description
Brief 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).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Neuromuscular Research Center and Clinic, Paradise Valley, Arizona, United States
HonorHealth Neurology, Scottsdale, Arizona, United States
University of Southern California, Los Angeles, California, United States
Stanford University, Palo Alto, California, United States
Care Access Research, Pasadena, California, United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Yale New Haven Hospital, New Haven, Connecticut, United States
FM Clinical Research, LLC South Florida Neurology Associates, P. A., Boca Raton, Florida, United States
University of Florida Health Jacksonville, Jacksonville, Florida, United States
Medsol Clinical Research Center Inc, Port Charlotte, Florida, United States
University of South Florida, Tampa, Florida, United States
Augusta University, Augusta, Georgia, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
St. Elizabeth Medical Center, Boston, Massachusetts, United States
Lahey Hospital & Medical Center, Burlington, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Duke University School of Medicine, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Wesley Neurology, Cordova, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
University of Vermont, Burlington, Vermont, United States
Melbourne Neurology Group, North Melbourne, , Australia
Gold Coast University Hospital, Southport, , Australia
ULB Hôpital Erasme, Anderlecht, , Belgium
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Cliniques Universitaires Saint Luc, Brussels, , Belgium
AZ Sint-Lucas, Gent, , Belgium
University Hospitals Leuven, Leuven, , Belgium
The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Beijing Tiantan Hospital, Capital Medical University, Beijing, , China
Xuanwu Hospital ,Capital Medical University, Beijing, , China
Beijing Hospital, Beijing, , China
The First Bethune Hospital of Jilin University, Changchun, , China
Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Fujian Medical University Union Hospital, Fuzhou, , China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Qianfoshan hospital of Shandong Province, Jinan, , China
Qilu Hospital of Shandong University, Jinan, , China
Huashan Hospital Fudan University, Shanghai, , China
Tianjin Medical University General Hospital, Tianjin, , China
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital, Xi'An, , China
Neurologie a rehabilitace Skopalíkova, Brno, , Czechia
Fakultni nemocnice Brno, Brno, , Czechia
Vseobecna Fakultní Nemocnice, Praha, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Rigshospitalet, København Ø, , Denmark
Hopital Pierre Wertheimer, Bron, , France
CHU Grenoble, Grenoble, , France
Hopital de la Pitie Salpetriere, Paris, , France
Hopital PASTEUR, Provence-Alpes-Côte d'Azur, , France
NeuroCure Clinical Research Center, Berlin, , Germany
Universitatsmedizin Gottingen, Göttingen, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie, Wiesbaden, , Germany
U.O.P.I. di Psichiatria, Catania, , Italy
Fondazione Istituto G. Giglio, Cefalu, , Italy
Istituto Neurologico Carlo Besta, Milano, , Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli, Napoli, , Italy
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione, Pavia, , Italy
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza, Roma, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Chiba University Hospital, Chiba, , Japan
General Hanamaki Hospital, Hanamaki, , Japan
Hiroshima University Hospital, Hiroshima shi, , Japan
Teikyo University Hospital, Itabashi Ku, , Japan
St Marianna University Hospital, Kawasaki Shi, , Japan
Kagawa University Hospital, Kita-Gun, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Iwate Medical University Hospital, Morioka-shi, , Japan
National Hospital Organization Nagoya Medical Center, Nagoya-shi, , Japan
Niigata City General Hospital, Niigata, , Japan
Hyogo College of Medicine Hospital, Nishinomiya-Shi, , Japan
Sapporo Medical University Hospital, Sapporo, , Japan
Hokkaido Medical Center, Sapporo, , Japan
National Hospital Organization Sendai Medical Center, Sendai-City, , Japan
Tokushima University Hospital, Tokushima, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
iBiomed Research Unit, Aguascalientes, , Mexico
Consultorio Dr. Miguel Cortes, Cuernavaca, , Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, , Mexico
Neurocentrum Bydgoszcz Sp Z O O, Bydgoszcz, , Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis', Katowice, , Poland
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii, Krakow, , Poland
Prywatny Gabinet Lekarski, Lublin, , Poland
Centrum Medyczne NeuroProtect, Warsaw, , Poland
Hosp. Gral. Univ. de Alicante, Alicante, , Spain
Hosp. de La Santa Creu I Sant Pau, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hosp. Univ. de Basurto, Bilbao, , Spain
Hosp. Virgen Macarena, Sevilla, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Karlstad Central Hospital, Karlstad, , Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
China Medical University Hospital, Taichung, , Taiwan
Shin Kong Wu Ho Su Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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