A Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
研究单位：[1]Biogen[2]University of Alabama Birmingham,Birmingham,Alabama,United States,35294[3]Arizona Arthritis & Rheumatology Associates, P.C.,Glendale,Arizona,United States,85306[4]Valerius Medical Group,Los Alamitos,California,United States,90720[5]Medvin Clinical Research,Whittier,California,United States,90602[6]RASF - Clinical Research Center,Boca Raton,Florida,United States,33486[7]University of Florida Gainesville,Gainesville,Florida,United States,32611[8]University of Miami Miller School of Medicine,Miami,Florida,United States,33136[9]Clinical Research of West Florida, Inc.,Tampa,Florida,United States,33606[10]The Emory Clinic Emory University,Atlanta,Georgia,United States,30322[11]Jefrey Lieberman, M.D., P.C.,Decatur,Georgia,United States,30033[12]Arthritis Center of North Georgia,Gainesville,Georgia,United States,30501[13]Rush University Medical Center,Chicago,Illinois,United States,60612[14]Boston University School of Medicine,Boston,Massachusetts,United States,02118[15]University of Massachusetts,Worcester,Massachusetts,United States,01605[16]Saint Louis Rheumatology,Saint Louis,Missouri,United States,63117[17]Arthritis & Osteoporosis Associates, PA,Freehold,New Jersey,United States,07728[18]Arthritis and Osteoporosis Associates of New Mexico,Las Cruces,New Mexico,United States,88011[19]DJL Clinical Research, PLLC,Charlotte,North Carolina,United States,28210[20]Carolina Arthritis Associates,Wilmington,North Carolina,United States,28401[21]University of Cincinnati,Cincinnati,Ohio,United States,45219[22]STAT Research,Dayton,Ohio,United States,45417[23]Piedmont Arthritis Clinic, P.A.,Greenville,South Carolina,United States,29601[24]Low Country Rheumatology, PA,Summerville,South Carolina,United States,29486[25]West Tennessee Research Institute,Jackson,Tennessee,United States,38305[26]Office of John P. Lavery M.D., PA,Allen,Texas,United States,75013[27]Tekton Research,Austin,Texas,United States,78745[28]Precision Comprehensive Clinical Research Solutions,Colleyville,Texas,United States,76034[29]SouthWest Rheumatology Research, LLC,Mesquite,Texas,United States,75150[30]Sun Research Institute, LLC,San Antonio,Texas,United States,78215[31]The University of Texas Health,San Antonio,Texas,United States,78229[32]Swedish Medical Center,Seattle,Washington,United States,98104[33]Hospital General de Agudos Dr. J. M. Ramos Mejia,Ciudad Autonoma Buenos Aires,Buenos Aires,Argentina,C1221ADC[34]Centro de Investigaciones Medicas Mar del Plata,Mar del Plata,Buenos Aires,Argentina,7600[35]Policlìnica Red Omip S.A - Ensayos Clinicos GC,Mar del Plata,Buenos Aires,Argentina,B7600GNY[36]Centro Dermatologico Schejtman,San Miguel,Buenos Aires,Argentina,B1663[37]APRILLUS Asistencia e Investigacion,Ciudad Autonoma de Buenos Aires,Ciudad Autonoma Buenos Aires,Argentina,C1406AGA[38]Instituto de Investigaciones Clinicas Quilmes,Buenos Aires,Provincia De Buenos Aires,Argentina,B1878[39]Hospital Italiano de La Plata,Buenos Aires,Provincia De Buenos Aires,Argentina,B1900[40]Centro de Investigaciones Medicas Tucuman,San Miguel de Tucuman,Tucuman,Argentina,T4000AXL[41]Investigaciones Clinicas Tucuman,San Miguel de Tucumán,Tucuman,Argentina,T4000ICL[42]Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada,Ciudad Autonoma Buenos Aires,Argentina,1425[43]STAT Research S.A.,Ciudad Autonoma Buenos Aires,Argentina,C1013AAB[44]Organizacion Medica de Investigacion (OMI),Ciudad Autonoma Buenos Aires,Argentina,C1015ABO[45]Centro Privado de Medicina Familiar - Mind Out Research,Ciudad Autonoma Buenos Aires,Argentina,C1417[46]Centro Medico Barrio Parque,Ciudad Autonoma de Buenos Aires,Argentina,C1425[47]Instituto de Reumatologia,Mendoza,Argentina,M5500[48]CER San Juan Centro Polivalente de Asistencia e Inv. Clinica,San Juan,Argentina,5400[49]UZ Leuven,Leuven,Belgium,3000[50]CHU de Liège,Liege,Belgium,4000[51]The Waterside Clinic
The primary objective of this study is to demonstrate efficacy of litifilimab (BIIB059) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. The secondary objectives of this study are to demonstrate early onset of efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of litifilimab compared with placebo in reducing oral corticosteroid(s) (OCS) use; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of litifilimab compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of litifilimab compared with placebo in reducing OCS use; to assess the difference between litifilimab and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of litifilimab in participants with active SLE and to evaluate immunogenicity of litifilimab in participants with active SLE.
