A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
研究单位：[1]argenx[2]HonorHealth Neurology - Bob Bove Neuroscience Institute,Scottsdale,Arizona,United States,85251[3]Loma Linda University Health,Fresno,California,United States,93701-2234[4]First Choice Neurology Boca Raton,Boca Raton,Florida,United States,33428[5]SFM Clinical Research LLC,Boca Raton,Florida,United States,33487[6]The Neurology Institute / Healthcare Innovations Institute - Coral Springs,Coral Springs,Florida,United States,33067[7]Neurology Associates PA,Maitland,Florida,United States,32751[8]University of Miami Miller School of Medicine,Miami,Florida,United States,33136-2137[9]Medsol Clinical Research Center Inc,Port Charlotte,Florida,United States,33952[10]BayCare - St. Anthony's Hospital,Saint Petersburg,Florida,United States,33705-1410[11]University of South Florida (USF) Health - Morsani Center for Advanced Healthcare,Tampa,Florida,United States,33612[12]Wellstar - Augusta University Medical Center,Augusta,Georgia,United States,30912[13]Northwestern Medicine - Northwestern Memorial Hospital,Chicago,Illinois,United States,60611[14]Kansas University Medical Center - Kansas City,Fairway,Kansas,United States,66205[15]Massachusetts General Hospital,Boston,Massachusetts,United States,02114[16]Henry Ford Health - Henry Ford Hospital,Detroit,Michigan,United States,48202[17]Saint Louis University,Saint Louis,Missouri,United States,63106[18]Rutgers-Robert Wood Johnson Medical School,New Brunswick,New Jersey,United States,08901-1962[19]University of North Carolina - Chapel Hill,Chapel Hill,North Carolina,United States,27599-7025[20]Carolinas HealthCare System Neurosciences Institute-Neurology,Charlotte,North Carolina,United States,28207-1885[21]Duke University School of Medicine - Duke Early Phase Clinical Research Unit,Durham,North Carolina,United States,27710[22]Cleveland Clinic,Cleveland,Ohio,United States,44195-0001[23]Cleveland Clinic,Cleveland,Ohio,United States,44195[24]Penn Presbyterian Medical Center,Philadelphia,Pennsylvania,United States,19104[25]Erlanger Neuroscience Institute,Chattanooga,Tennessee,United States,37403-2173[26]National Neuromuscular Research Institute,Austin,Texas,United States,78756[27]Virginia Commonwealth University,Richmond,Virginia,United States,23298-5048[28]University of Washington Medical Center - Montlake,Seattle,Washington,United States,98195[29]Hôpital Erasme,Anderlecht,Belgium,1070[30]Cliniques Universitaires Saint-Luc,Brussels,Belgium,1200[31]UZ Leuven,Leuven,Belgium,3000[32]Ottawa Hospital - Civic Campus,Ottawa,Canada,K1H 8L6[33]Xuanwu Hospital Capital Medical University,Beijing,China,100053[34]Sichuan Academy of Medical Sciences & Sichuan Provincial People''s Hospital,Chongqing,China,400016[35]The First Affiliated Hospital of Chongqing Medical University,Chongqing,China,400016[36]Fujian Medical University Union Hospital,Fuzhou,China,350001[37]The First Affiliated Hospital of Guangxi Medical University,Guangxi,China,530021[38]The First Affiliated Hospital of Guangzhou University Chinese Medicine,Guangzhou,China,510405[39]Guangdong Province Traditional Chinese Medical Hospital,Guangzhou,China,518053[40]The Affiliated Hospital of Guizhou Medical University,Guiyang,China,550004[41]Ningbo Medical Center Lihuili Hospital,Ningbo,China,315041[42]Huashan Hospital Fudan University,Shanghai,China,200040[43]Tongji Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan,China,430030[44]Cyprus Institute of Neurology and Genetics,Egkomi,Cyprus,2371[45]Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice,Pardubice,Czech Republic,530 03[46]Aarhus Universitetshospital,Aarhus,Denmark,8200[47]Odense Universitetshospital,Odense C,Denmark,5000[48]Turun Yliopistollinen Keskussairaala,Turku,Finland,20540[49]CHU de Nice-Hôpital Pasteur,Nice,France,06000[50]AP-HP - Hôpital de la Pitié Salpétrière,Paris,France,75013[51]West Georgia Medical Center,Kutaisi,Georgia,4600[52]Petre Sarajishvili Institute of Neurology,Tbilisi,Georgia,0112
研究目的：
The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod. Study will consist of: - Screening - Part A: participants will be randomized to receive either efgartigimod IV or placebo - Part B: participants completing part A will receive open-label efgartigimod IV
