A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
研究单位：[1]Biogen[2]Pinnacle Research Group, LLC,Anniston,Alabama,United States,36207[3]UAB Center for Women''s Reproductive Health,Birmingham,Alabama,United States,35233-7340[4]Arizona Arthritis & Rheumatology Research, PLLC,Phoenix,Arizona,United States,85032[5]The Regents of the University of California,La Jolla,California,United States,92037[6]Dermatology Research Associates,Los Angeles,California,United States,90045[7]Clinical Science Institute,Santa Monica,California,United States,90404[8]Inland Rheumatology Clinical Trials, Inc.,Upland,California,United States,91786[9]Denver Arthritis Clinic,Denver,Colorado,United States,80230[10]Omega Research Debary, LLC,DeBary,Florida,United States,32713[11]Centre for Rheumatology, Immunology and Arthritis,Fort Lauderdale,Florida,United States,33334[12]University of Florida,Gainesville,Florida,United States,32610[13]Charisma Medical and Research Center,Miami Lakes,Florida,United States,33014[14]University of Miami Miller School of Medicine,Miami,Florida,United States,33125[15]Medical Research Center of Miami,Miami,Florida,United States,33134[16]OrthoIllinois,Rockford,Illinois,United States,61114[17]Dawes Fretzin Clinical Research Group, LLC,Indianapolis,Indiana,United States,46250[18]Tufts Medical Center,Boston,Massachusetts,United States,02111[19]Brigham And Women''s Hospital,Boston,Massachusetts,United States,02115[20]Essential Dermatology,Natick,Massachusetts,United States,01760[21]Beacon Clinical Research, LLC,Quincy,Massachusetts,United States,02169[22]University of Massachusetts, Worcester,Worcester,Massachusetts,United States,01655[23]David Fivenson, MD, Dermatology, PLLC,Ann Arbor,Michigan,United States,48103[24]Oakland Hills Dermatology,Auburn Hills,Michigan,United States,48326[25]AA MRC LLC Ahmed Arif Medical Research Center,Flint,Michigan,United States,48504[26]Revival Research Institute, LLC,Troy,Michigan,United States,48084[27]Saint Louis University,Saint Louis,Missouri,United States,63110[28]University of Nebraska Medical Center,Omaha,Nebraska,United States,68198[29]Albuquerque Center For Rheumatology,Albuquerque,New Mexico,United States,87102[30]University of New Mexico School of Medicine,Albuquerque,New Mexico,United States,87106[31]NYU Langone Brooklyn,Brooklyn,New York,United States,11220[32]Universal Dermatology, PLLC,Fairport,New York,United States,14450[33]Northwell Health, Inc. PRIME,Great Neck,New York,United States,11021[34]Columbia University Medical center,New York,New York,United States,10032[35]University of North Carolina at Chapel Hill,Chapel Hill,North Carolina,United States,27514[36]Duke Dermatology South Durham,Durham,North Carolina,United States,27710[37]Medication Management, LLC,Greensboro,North Carolina,United States,27405[38]University of Cincinnati Department of Dermatology,Cincinnati,Ohio,United States,45219[39]University Hospitals Cleveland Medical Center,Cleveland,Ohio,United States,44106[40]Ohio State University,Columbus,Ohio,United States,43210[41]Penn State University Milton S. Hershey Medical Center,Hershey,Pennsylvania,United States,17033[42]University of Pennsylvania,Philadelphia,Pennsylvania,United States,19104[43]Vanderbilt University Medical Center,Nashville,Tennessee,United States,37232[44]Austin Regional Clinic, P.A.,Austin,Texas,United States,78731[45]Precision Comprehensive Clinical Research Solutions,Colleyville,Texas,United States,76034[46]Metroplex Clinical Research Center, LLC,Dallas,Texas,United States,75231[47]UT Southwestern Medical Center,Dallas,Texas,United States,75390-8896[48]North Texas Center for Clinical Research,Frisco,Texas,United States,75034[49]UTMB Department of Dermatology,Galveston,Texas,United States,77555-0583[50]University of Texas Health Science Center at Houston,Houston,Texas,United States,77054[51]Arthritis & Osteoporosis Clinic,Waco,Texas,United States,76710[52]University of Utah Health Sciences Center,Salt Lake City,Utah,United States,84132[53]West End Dermatology Associates,Richmond,Virginia,United States,23233[54]CINME - Centro De Investigaciones Metabolicas,Caba,Buenos Aires,Argentina,C1056ABI[55]Centro de Investigaciones Medicas Mar del Plata,Mar del Plata,Buenos Aires,Argentina,7600[56]Instituto de Investigaciones Clinicas Quilmes,Quilmes,Buenos Aires,Argentina,B1878GEG[57]APRILLUS Asistencia e Investigacion,Ciudad Autonoma de Buenos Aires,Ciudad Autonoma Buenos Aires,Argentina,C1406AGA[58]Fundacion Respirar,Ciudad Autonoma de Buenos Aires,Ciudad Autonoma Buenos Aires,Argentina,C1426ABO[59]Instituto CAICI,Rosario,Santa Fe,Argentina,S2000PBJ[60]Clinica Mayo de Urgencias Medicas Cruz Blanca SRL,San Miguel de Tucuman,Tucuman,Argentina,4000[61]Beijing Tongren Hospital, Capital Medical University,Beijing,China,100730
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].
