A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis

Last Updated   November 23, 2022 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    136 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

DETAILS

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.

LOCATIONS

Locations in:
United States, United Kingdom, Taiwan, Sweden, Spain, South Korea, Poland, Mexico, Japan, Italy, Germany, France, Denmark, Czechia, Colombia, China, Canada, Belgium, Australia
Country (19) City or Province (136) Status
United States Augusta, GA Augusta University
Recruiting
United States Aurora, CO University of Colorado - Anschutz Medical Campus
Recruiting
United States Boca Raton, FL FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Recruiting
United States Boston, MA St. Elizabeth Medical Center
Recruiting
United States Burlington, MA Lahey Hospital & Medical Center
Recruiting
United States Burlington, VT University of Vermont
Recruiting
United States Charleston, SC Medical University of South Carolina
Recruiting
United States Charlotte, NC Atrium Health
Withdrawn
United States Cincinnati, OH University of Cincinnati
Recruiting
United States Cleveland, OH Cleveland Clinic
Recruiting
United States Columbus, OH The Ohio State University
Recruiting
United States Cordova, TN Wesley Neurology
Recruiting
United States Dallas, TX UT Southwestern Medical Center
Recruiting
United States Durham, NC Duke University School of Medicine
Recruiting
United States Jacksonville, FL University of Florida
Recruiting
United States Kansas City, KS University of Kansas Medical Center
Recruiting
United States Las Vegas, NV Las Vegas Medical Research
Withdrawn
United States Los Angeles, CA University of Southern California
Recruiting
United States Mobile, AL IMC-Diagnostic and Medical Clinic
Withdrawn
United States New Haven, CT Yale New Haven Hospital
Recruiting
United States New Orleans, LA Ochsner Clinic Foundation
Withdrawn
United States Palo Alto, CA Stanford University
Recruiting
United States Paradise Valley, AZ Neuromuscular Research Center and Clinic
Recruiting
United States Pasadena, CA Care Access Research
Recruiting
United States Port Charlotte, FL Medsol Clinical Research Center Inc
Recruiting
United States Scottsdale, AZ HonorHealth Neurology
Recruiting
United States St. Louis, MO Washington University School of Medicine
Recruiting
United States Tampa, FL University of South Florida
Recruiting
United Kingdom Birmingham, WMD University Hospitals Birmingham NHS Foundation Trust
Withdrawn
United Kingdom London St George's Hospital
Withdrawn
United Kingdom Sheffield, SYK Sheffield Teaching Hospitals NHS Foundation Trust
Withdrawn
Taiwan Taichung China Medical University Hospital
Recruiting
Taiwan Taipei Shin Kong Wu Ho Su Memorial Hospital
Recruiting
Taiwan Taipei Taipei Veterans General Hospital
Recruiting
Sweden Karlstad Karlstad Central Hospital
Recruiting
Sweden Stockholm Karolinska Universitetssjukhuset Solna
Not yet recruiting
Spain Alicante, AC HOSP. GRAL. UNIV. DE ALICANTE
Recruiting
Spain Barcelona, BA HOSP. DE LA SANTA CREU I SANT PAU
Recruiting
Spain Barcelona, BA HOSP. UNIV. VALL D HEBRON
Recruiting
Spain Barcelona, BA Hosp. Clinic I Provincial De Barcelona
Recruiting
Spain Bilbao HOSP. UNIV. DE BASURTO
Recruiting
Spain Madrid, MD HOSP. GRAL. UNIV. GREGORIO MARAÑON
Withdrawn
Spain Sevilla HOSP. VIRGEN DEL ROCIO
Recruiting
Spain Sevilla HOSP. VIRGEN MACARENA
Recruiting
Spain Valencia, VC HOSP. UNIV. I POLITECNI LA FE
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
Recruiting
South Korea Seoul Korea University Medical Center (KUMC) - Korea University Anam Hospital
Withdrawn
South Korea Seoul Severance Hospital, Yonsei University Health System
Recruiting
South Korea Yangsan-si, 48 Pusan National University Yangsan Hospital
Withdrawn
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 Lodz Centrum Neurologii Krzysztof Selmaj
Withdrawn
Poland Lodz Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Uniwersytetu Medycznego w Łodzi
Withdrawn
Poland Lublin Prywatny Gabinet Lekarski
Recruiting
Poland Warsaw Centrum Medyczne Neuromedica
Recruiting
Mexico Aguascalientes, AGU iBiomed Research Unit
Recruiting
Mexico Cuernavaca, MOR Consultorio Dr. Miguel Cortes
Recruiting
Mexico Guadalajara, JAL Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
Japan Chiba Chiba University Hospital
Recruiting
Japan Hanamaki, 03 General Hanamaki Hospital
Recruiting
Japan Hiroshima-shi Hiroshima University Hospital
Recruiting
Japan Kawasaki-Shi, 14 St.Marianna University Hospital
Recruiting
Japan Kita-Gun, 37 Kagawa University Hospital
Recruiting
Japan Kumamoto, 43 Kumamoto University Hospital
Recruiting
Japan Morioka-shi, 03 Iwate Medical University Hospital
Recruiting
Japan Nagoya-shi National Hospital Organization Nagoya Medical Center
Recruiting
Japan Niigata, 15 Niigata City General Hospital
Recruiting
Japan Nishinomiya-Shi, 28 Hyogo College of Medicine Hospital
Recruiting
Japan Osaka-Sayama-shi, 27 Kindai University Hospital
Withdrawn
Japan Sapporo, 01 Hokkaido Medical Center
Recruiting
Japan Sapporo, 01 Sapporo Medical University Hospital
Recruiting
Japan Sendai-City National Hospital Organization Sendai Medical Center
Recruiting
Japan Tokushima Tokushima University Hospital
Not yet recruiting
Japan Tokyo, 13 Teikyo University Hospital
Recruiting
Japan Tokyo, 13 Tokyo Medical University Hospital
Recruiting
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
Germany Berlin, BE NeuroCure Clinical Research Center
Not yet recruiting
Germany Gummersbach Kreiskrankenhaus Gummersbach
Withdrawn
Germany Göttingen Universitätsmedizin Göttingen
Recruiting
Germany Jena Universitätsklinikum Jena
Withdrawn
Germany Leipzig Universitatsklinikum Leipzig
Recruiting
Germany Lübeck, SH Universitätsklinikum Schleswig Holstein Campus Lübeck
Recruiting
Germany München Klinikum rechts der Isar der TU Munchen
Withdrawn
Germany Ulm, BW Universitätsklinikum Ulm
Recruiting
Germany Wiesbaden, HE DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
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
France Provence-Alpes-Côte d'Azur Hopital PASTEUR
Recruiting
Denmark Aalborg Aalborg University Hospital
Recruiting
Denmark Aarhus Aarhus Universitetshospital
Withdrawn
Denmark København Ø Rigshospitalet
Recruiting
Czechia Brno Fakultni nemocnice Brno
Not yet recruiting
Czechia Brno Neurologie a rehabilitace Skopalíkova
Recruiting
Czechia Ostrava Fakultni nemocnice Ostrava
Withdrawn
Czechia Praha VSEOBECNA FAKULTNÍ NEMOCNICE
Recruiting
Colombia BUCARAMANGA, SAN MEDICITY S.A.S
Withdrawn
Colombia Floridablanca, SAN FUNDACION CARDIOVASCULAR DE COLOMBIA
Withdrawn
China Beijing, 11 Beijing Hospital
Recruiting
China Beijing, 11 Beijing Tiantan Hospital, Capital Medical University
Not yet recruiting
China Beijing, 11 Peking Union Medical College Hospital
Not yet recruiting
China Beijing, 11 Xuanwu Hospital, Capital Medical University
Not yet 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
Not yet recruiting
China Fuzhou Fujian Medical University Union Hospital
Not yet recruiting
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 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Branch
Withdrawn
China Shanghai, 31 Huashan Hospital Fudan University
Recruiting
China Tianjin, 12 Tianjin Medical University General Hospital
Recruiting
China Xi'An The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Recruiting
Canada Montreal, QC McGill University
Recruiting
Canada Ottawa, ON The Ottawa Hospital Research Institute
Not yet recruiting
Canada Toronto, ON Toronto General Hospital
Not yet recruiting
Canada Vancouver, BC Vancouver General Hospital
Withdrawn
Belgium Anderlecht, BRU ULB Hôpital Erasme
Recruiting
Belgium Brugge AZ Sint-Jan Brugge-Oostende AV
Recruiting
Belgium Brussels, BRU Cliniques Universitaires Saint Luc
Recruiting
Belgium Gent AZ Sint-Lucas
Recruiting
Belgium LEUVEN University Hospitals Leuven
Recruiting
Australia Douglas, QLD Townsville Hospital
Not yet recruiting
Australia North Melbourne, VIC Melbourne Neurology Group
Not yet recruiting
Australia Southport, QLD Gold Coast University Hospital
Not yet recruiting
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