南京Litifilimab(BIIB059)III期临床试验-一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的成人受试者中评价 BIIB059 (Litifilimab) 持续安全性和疗效的多中心、开放性、单组、III 期长期扩展临床研究 (AMETHYST LTE)

登记号	CTR20251514	试验状态	进行中
申请人联系人	陈依迪	首次公示信息日期	2025-04-17
申请人名称	Biogen Idec Research Limited/ 渤健生物科技（上海）有限公司/ Vetter Pharma-Fertigung GmbH & Co. KG

登记号	CTR20251514
相关登记号	暂无
药物名称	Litifilimab (BIIB059)
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	有或无全身表现且抗疟药治疗反应不佳和/或不耐受的活动性亚急性皮肤型红斑狼疮 (SCLE) 和/或慢性皮肤型红斑狼疮(CCLE)。
试验专业题目	一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的成人受试者中评价 BIIB059 (Litifilimab) 持续安全性和疗效的多中心、开放性、单组、III 期长期扩展临床研究 (AMETHYST LTE)
试验通俗题目	一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的成人受试者中评价 BIIB059 (Litifilimab) 持续安全性和疗效的多中心、开放性、单组、III 期长期扩展临床研究 (AMETHYST LTE)
试验方案编号	230LE305	方案最新版本号	1.2
版本日期:	2023-10-17	方案是否为联合用药	否

申请人名称	[["Biogen Idec Research Limited"],["渤健生物科技（上海）有限公司"],["Vetter Pharma-Fertigung GmbH & Co. KG"]]
联系人姓名	陈依迪	联系人座机	021-24156213	联系人手机号
联系人Email	edie.chen@biogen.com	联系人邮政地址	上海市-上海市-徐汇区陕西南路288号21层2106	联系人邮编	200000

评估 BIIB059（Litifilimab）在有或无全身表现且抗疟治疗反应不佳和/或不耐受的活动性亚急性 CLE 和/或慢性 CLE 受试者中的长期安全性和耐受性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	非随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["完成母研究（研究 230LE301，A 部分或 B 部分）的研究治疗（接受治疗直至第 48 周，并参加第 52 周的末次研究评估访视）的受试者。"],["受试者有能力理解研究的目的和风险、提供知情同意，以及授权研究人员根据国家和当地隐私法规使用其保密健康信息。"],["所有具有生育能力的女性均必须在研究期间以及研究治疗末次给药后的 126 天（18 周）内实施方案中第 ？11.5 节所述的高效避孕措施。此外，受试者在研究治疗期间以及研究治疗末次给药后至少 126 天（18 周）内不应捐献卵子。如适用，如果之前未在母研究中确认，女性受试者的绝经后状态必须确认如下：对于小于等于 55 岁的女性，无其他医学原因连续 52 周自然（自发性）闭经，血清 FSH 水平大于等于 40 mIU/mL； 对于大于 55 岁的女性，无其他医学原因连续 52 周自然（自发性）闭经，血清 FSH 水平大于等于 40 mIU/mL，或无其他医学原因至少连续 5 年自然（自发性）闭经。"]]
排除标准	[["A 部分或 B 部分母研究治疗提前终止者（在第 48 周前中止研究治疗的受试者）。"],["A 部分或 B 部分母研究提前终止者（在第 52 周前退出母研究且未完成母研究 ETP 的受试者）。"],["受试者发生任何其他医学疾病、病症或异常，研究者认为其不适合参加 LTE 研究。"],["受试者发生器官特异性狼疮表现中度至重度恶化，包括皮肤狼疮表现，需要改变免疫抑制治疗（开始新治疗或增加剂量至方案中表2 、表4 和表5 中规定的允许的最大剂量以上）。"],["在母研究期间使用禁止得合并用药、治疗或程序（方案中表6）。"],["在母研究期间使用其他试验性药物或适应症外药物治疗 SLE、CLE 或狼疮性肾炎。"],["基线访视前 4 周内和整个研究期间以及研究治疗末次给药后 24 周内接种活疫苗或减毒活疫苗。"],["在研究治疗期间和研究治疗末次给药后 126 天（18 周）内怀孕，目前正在哺乳或计划怀孕的女性受试者。"],["目前正入组或计划入组给予试验性治疗或获批试验性疗法的任何干预性临床研究。允许参与观察性注册研究。"],["无法遵循研究要求。"],["其他未列在此处的，且研究者或申办者认为受试者不适合入组研究的原因。"]]

试验药	[["中文通用名:Litifilimab(BIIB059) 英文通用名:Litifilimab(BIIB059) 商品名称:无","剂型:注射剂 规格:1.5mL:225mg(预填充式注射器) 用法用量:Litifilimab225mg，每4周一次（Q4W）。 用药时程:每名受试者参与研究的持续时间最长约为128周。"]] 序号 名称 用法
对照药	暂未填写此信息 序号 名称 用法

主要终点指标及评价时间

[["整个 LTE 期内 TEAE 和 SAE 的发生率","研究期间","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["各次访视时达到 CLASI-70、CLASI-50 和 CLASI-90 应答的受试者比例，定义为 CLASI-A 评分相对于基线值（母研究）改善 70%、50% 和 90%","研究期间","有效性指标"],["各次访视时 CLA-IGA-R 红斑评分为 0 或 1 的受试者比例。","研究期间","有效性指标"],["各次访视时 CLA-IGA-R OMC 评分为 0 或 1 的受试者比例。","研究期间","有效性指标"],["各次访视时持续 CLASI-70、CLASI-50 和 CLASI-90 应答的累积持续时间，定义为 CLASI-A 评分相对于基线值（母研究）改善 70%、50% 和 90% 的周数。","研究期间","有效性指标"],["在母研究第 52 周时实现CLASI-70、CLASI-50 和 CLASI-90 应答者中在各次访视时分别具有 CLASI-70、CLASI-50 和 CLASI-90 应答的受试者比例。","第52周","有效性指标"],["在母研究第 52 周时 CLA-IGA-R 红斑评分为 0 或 1 的受试者中在各次访视时 CLA-IGA-R 红斑评分为 0 或 1 的受试者比例。","第52周","有效性指标"],["在母研究第 52 周时实现CLASI-50 应答者中在各次访视时实现CLASI-70 应答的受试者比例。","第52周","有效性指标"],["在母研究第 52 周时实现CLASI-50 应答者中在各次访视时实现CLASI-90 应答的受试者比例。","第52周","有效性指标"],["在母研究第 52 周时实现CLASI-70 应答者中在各次访视时实现 CLASI-90 应答的受试者比例。","第52周","有效性指标"],["失去应答的受试者比例，定义为 在各次访视时CLASI-A 总评分较基线值（LTE 研究）增加大于等于 7 分。","研究期间","有效性指标"],["失去应答的受试者比例，定义为在 LTE 研究开始时或期间 CLA-IGA-R 红斑评分较基线值（母研究）改善 2 分，然后在各次访视时恢复至 CLA-IGA-R 红斑基线值（母研究）。","研究期间","有效性指标"],["失去应答的受试者比例，定义为 在各次访视时CLA-IGA-R 红斑评分较母研究中最低评分恶化至少 2、3 和 4 分。","研究期间","有效性指标"],["CLASI-D 评分从基线（母研究）到第 104 周的绝对值和百分比变化。","第104周","有效性指标"],["从基线值（母研究）到 LTE 期第 104 周的年化轻度/中度 SFI 发生率和年化重度 SFI 发生率。","第104周","有效性指标+安全性指标"],["各次访视时OCS 剂量n？各次访视时OCS小于等于 7.5 mg/天的受试者比例n？各次访视时OCS小于等于 5.0 mg/天的受试者比例","研究期间","有效性指标+安全性指标"],["52 周和第 104 周较基线值（母研究）的如下变化：n？CLE-QoLn？EQ-5D-3Ln？SF-36（急性版本）n？WPAI：狼疮n？PHQ-9","第52周和第104周","有效性指标+安全性指标"],["各次访视时标准实验室参数和 ECG 结果较基线值（母研究）的变化。","研究期间","有效性指标+安全性指标"],["研究期间血清中 抗Litifilimab 抗体的发生率。","研究期间","有效性指标+安全性指标"],["研究期间 Litifilimab 血清浓度-时间曲线。","研究期间","有效性指标+安全性指标"],["从基线值（母研究）到 LTE 期第 52 周的年化轻度/中度 SFI 发生率和年化重度 SFI 发生率","第52周","有效性指标+安全性指标"],["持续疗效的累积持续时间，定义为 LTE 研究期间各次访视时的周数，其中","研究期间","有效性指标"],["CLA-IGA-R 红斑评分为 0 或 1，CLA-IGA-R OMC 评分为 0 或 1，且较基线值（母研究）改善至少 1 分，或CLA-IGA-R 毛囊活性评分为 0 的周数。","研究期间","有效性指标"],["在母研究第 52 周时CLA-IGA-R OMC 分数为 0 或 1 且与基线值（母研究）相比实现至少 1 级改善的受试者中在","第52周","有效性指标"],["各次访视时CLA-IGA-R OMC 分数为 0 或 1 且与基线值（母研究）相比实现至少 1 级改善的受试者比例","第52周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	陆前进	学位	医学博士	职称	正高级
	电话	13787097676	Email	qianlu5860@pumcderm.cams.cn	邮政地址	江苏省-南京市-玄武区蒋王庙街12号
	邮编	210042	单位名称	中国医学科学院皮肤病医院（中国医学科学院皮肤病研究所）

[["中国医学科学院皮肤病医院（中国医学科学院皮肤病研究所）","陆前进","中国","江苏省","南京市"],["吉林大学第一医院","李珊山","中国","吉林省","长春市"],["中南大学湘雅二医院","龙海","中国","湖南省","长沙市"],["南方医科大学南方医院","郑跃","中国","广东省","广州市"],["首都医科大学附属北京朝阳医院","何焱玲","中国","北京市","北京市"],["复旦大学附属中山医院","杨骥","中国","上海市","上海市"],["中国医学科学院北京协和医院","晋红中","中国","北京市","北京市"],["山东大学齐鲁医院","孙青","中国","山东省","济南市"],["上海交通大学医学院附属瑞金医院","郑捷","中国","上海市","上海市"],["杭州市第一人民医院","吴黎明","中国","浙江省","杭州市"],["昆明医科大学第二附属医院","邓丹琪","中国","云南省","昆明市"],["中山大学孙逸仙纪念医院","郭庆","中国","广东省","广州市"],["河南省人民医院","李建国","中国","河南省","南阳市"],["上海市皮肤病医院","丁杨峰","中国","上海市","上海市"],["浙江大学医学院附属第一医院","方红","中国","浙江省","杭州市"],["深圳市第二人民医院","吴文中","中国","广东省","深圳市"],["福建医科大学附属第一医院","纪超","中国","福建省","福州市"],["重庆医科大学附属第一医院","方圣","中国","重庆市","重庆市"],["内蒙古科技大学包头医学院第一附属医院","王永福","中国","内蒙古自治区","包头市"],["南阳市第一人民医院","陈日新","中国","河南省","南阳市"],["首都医科大学附属北京同仁医院","杨秀敏","中国","北京市","北京市"],["东莞市人民医院","韩光明","中国","广东省","东莞市"],["江苏大学附属医院","李遇梅","中国","江苏省","镇江市"],["温州医科大学附属第一医院","李智铭","中国","浙江省","温州市"],["CINME - Centro De Investigaciones Metabolicas","Ricardo Galimberti","阿根廷","Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Instituto CAICI","Carolina Irma Dieguez","阿根廷","Santa Fe","Rosario"],["Hospital Italiano de La Plata","Rodrigo Nicolas Garcia Salinas","阿根廷","Buenos Aires","La Plata"],["APRILLUS Asistencia e Investigacion","Pablo Alejandro Mannucci Walter","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Centro Privado de Medicina Familiar - Mind Out Research","Leonardo Naftal","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Centro de Investigaciones Medicas Mar del Plata","Gladys Alicia Testa","阿根廷","Buenos Aires","Mar del Plata"],["Centro de Investigaciones Medicas Tucuman","Walter Spindler","阿根廷","Tucuman","San Miguel de Tucuman"],["Fundacion Respirar","Alejandro Arroyo","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Investigaciones Clinicas Tucuman","Veronica Ines Bellomio","阿根廷","Tucuman","San Miguel de Tucuman"],["San Miguel de Tucuman","Jose Luis Cristian Moreno","阿根廷","San Juan","San Juan"],["Instituto de Reumatologia","Alfredo Borgia","阿根廷","Mendoza","Mendoza"],["Instituto de Investigaciones Clinicas Quilmes","Jose Luis Velasco Zamora","阿根廷","Buenos Aires","Quilmes"],["Clinica Mayo de Urgencias Medicas Cruz Blanca SRL","Francisco Colombres","阿根廷","Tucuman","San Miguel de Tucuman"],["Clinica Adventista Belgrano","Federico Javier Ariel","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["CHU de Liege","CHU de Liege","比利时","NA","Liege"],["UZ Leuven","Petra De Haes","比利时","NA","Leuven"],["Cliniques Universitaires Saint-Luc","Pierre Dominique Ghislain","比利时","NA","Brussels"],["Universitair Ziekenhuis Gent","Reinhart Speeckaert","比利时","NA","Gent"],["HUWC - UFC - Hospital Universitário Walter Cantidio - Universidade Federal do Ceara","Vanessa Beatriz de Vasconcelos Marques","巴西","Ceara","Fortaleza"],["LMK Servios Medicos S/S Ltda","Mauro Waldemar Keiserman","巴西","Rio Grande do Sul","Porto Alegre"],["Hospital Bruno Born","Jussara Marilu Bohn","巴西","Rio Grande do Sul","Lajeado"],["CMiP - Centro Mineiro de Pesquisa","Silviane Vassalo","巴西","Minas Gerais","Juiz de Fora"],["Clinica SER da Bahia","Mittermayer Barreto Santiago","巴西","Bahia","Salvador"],["Santa Casa de Misericórdia de Belo Horizonte","Mariana Peixoto Guimaraes Ubirajara e Silva de Souza","巴西","Minas Gerais","Belo Horizonte"],["Nucleo de Pesquisa Clinica do Rio Grande do Sul","Cecilia Varella da Costa","巴西","Rio Grande do Sul","Porto Alegre"],["CEPIC - Centro Paulista de Investigacao Clinica e Servieos Medicos","Flora Maria D Andrea Marcolino","巴西","Sao Paulo","Sao Paulo"],["CEDOES - Diagnostico e Pesquisa","Valquiria Garcia Dinis","巴西","Espirito Santo","Vitoria"],["IPC MT Instituto de Pesquisas Clinicas do Mato Grosso","Luiz Sergio Guedes Barbosa","巴西","Mato Grosso","Santo Angelo"],["L2IP – Instituto de Pesquisas Clínicas Ltda.","Eduardo Vasconcellos","巴西","Distrito Federal","Distrito Federal"],["CEMEC – Centro Multidisciplinar de Estudos Clínicos","Paulo Ricardo Criado","巴西","Sao Paulo","SAO BERNARDO DO CAMPO"],["Hospital de Clinicas de Porto Alegre","Odirlei Andre Monticielo","巴西","Rio Grande do Sul","Porto Alegre"],["Instituto Brasil de Pesquisa Clinica-IBPCLIN S/A","Jaqueline Barbeito de Vasconcellos","巴西","Rio do Janeiro","Rio do Janeiro"],["IDERJ - Instituto de Dermatologia e Estetica do Brasil Ltda","Luna Azulay Abulafia","巴西","Luna Azulay Abulafia","Luna Azulay Abulafia"],["DCC Focus 5 - MEOH OOD","Grisha Mateev","保加利亚","NA","Sofia"],["UMHAT Dr. Georgi Stranski, EAD","Dimitar Gospodinov","保加利亚","NA","Pleven"],["DCC 1 - Ruse, EOOD","Nadezhda Kapandjieva","保加利亚","NA","Ruse"],["DCC Alexandrovska, EOOD","Petyo Brezoev","保加利亚","NA","Sofia"],["Medical Center Medconsult Pleven OOD","Kamelia Vekovska","保加利亚","NA","Pleven"],["Military Medical Academy - MHAT - Sofia","Boycho Oparanov","保加利亚","NA","Sofia"],["DCC Focus 5 - MEOH OOD","Rumen Stoilov","保加利亚","NA","Sofia"],["Dermatology Ottawa Research Centre","Michael Robern","加拿大","Ontario","Ottawa"],["DIEX Recherche Sherbrooke Inc.","Daniel Minier","加拿大","Quebec","Sherbrooke"],["Medicor Research Inc","Lyne Giroux","加拿大","Ontario","Sudbury"],["Laster Rejuvenation Clinics Edmonton D.T. Inc.","Maninder Longowal","加拿大","Alberta","Edmonton"],["Laser Rejuvenation Clinics, Inc.","Paul Kuzel","加拿大","Alberta","Calgary"],["CIEC - Centro Internacional de Estudios Clinicos","Fernando Valenzuela","智利","NA","Santiago"],["Clinical Research Chile SpA.","Alvaro San Martin Leal","智利","NA","Valdivia"],["Oncocentro APYS","Renato Eduardo Jimenez Calabrese","智利","NA","Vina del Mar"],["Dermacross","Claudia De La Cruz","智利","NA","Santiago"],["CeCim Biocinetic","Darwin Yanez Pizarro","智利","NA","Santiago"],["Centro Medico SkinMed","Juan Walter Gubelin Harcha","智利","NA","Las Condes"],["BioMedica Research Group","Elizabeth Jean Moreno Goio","智利","NA","Santiago"],["Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM","Patricia Julieta Velez Sanchez","哥伦比亚","NA","Bogota"],["SERVIMED S.A.S.","William Jose Otero Escalante","哥伦比亚","NA","Bucaramanga"],["Healthy Medical Center","Danny Alexis Gomez Mora","哥伦比亚","NA","Zipaquira"],["Centro de Investigacion Medico Asistencial S.A.S","Juan Jose Jaller Raad","哥伦比亚","NA","Barranquilla"],["Hopital Saint-Louis","Jean-David Bouaziz","法国","Paris","Cedex 10"],["Hopital Tenon","Francois Chasset","法国","Paris","Paris"],["Hopital Edouard Herriot - CHU Lyon","Cecile Lesort","法国","Rhone","Lyon"],["CHU Nice - Hopital de l Archet","Florence Le Duff","法国","Alpes Maritimes","Alpes Maritimes"],["Hopital Larrey","Cristina Bulai Livideanu","法国","Haute Garonne","Toulouse Cedex 9"],["Hopital Saint Eloi","Didier Bessis","法国","Herault","Montpellier Cedex 5"],["Hopital Prive dAntony","Pierre-Andre Becherel","法国","Hauts de Seine","Antony"],["CHU Besancon - Hopital Jean Minjoz","Julie Castagna","法国","Doubs","Besane on Cedex"],["Hopital de la Timone","Marie-Aleth Richard","法国","Bouches-du-Rhone","Marseille cedex 5"],["Whipps Cross University Hospital","Bewley Anthony","英国","Greater London","London"],["Manchester Royal Infirmary","Parker Benjamin","英国","Greater Manchester","Manchester"],["Chapel Allerton Hospital","Laws Philip","英国","West Yorkshire","Leeds"],["Queen Elizabeth Hospital","Martin-Clavijo Agustin","英国","West Midlands","Birmingham"],["Omega Research Debary, LLC","Ayesu Kwabena","美国","Florida","Debary"],["David Fivenson, MD, Dermatology, PLLC","Fivenson David","美国","Michigan","Ann Arbor"],["Clinical Science Institute","Yamauchi Paul","美国","California","Santa Monica"],["Inland Rheumatology Clinical Trials, Inc.","Lee Eric","美国","California","Upland"],["Centre for Rheumatology, Immunology and Arthritis","Sherrer Yvonne","美国","Florida","Fort Lauderdale"],["Revival Research Institute, LLC","Moiin Ali","美国","Michigan","Troy"],["Dermatology Research Associates","Sofen Howard","美国","California","Los Angeles"],["NYU Langone Brooklyn","Goddard David","美国","New York","Brooklyn"],["University of Pennsylvania","Werth Victoria","美国","Pennsylvania","Philadelphia"],["Ohio State University","Kaffenberger Benjamin","美国","Ohio","Columbus"],["Arizona Arthritis & Rheumatology Research, PLLC","Chohan Saima","美国","Arizona","Glendale"],["Northwell Health, Inc. PRIME","Furie Richard","美国","New York","Great Neck"],["Dawes Fretzin Dermatology Group, LLC","Fretzin Scott","美国","Indiana","Indianapolis"],["UT Southwestern Medical Center","Chong Benjamin","美国","Texas","Dallas"],["Arthritis & Osteoporosis Clinic","Fung HS Eugene","美国","Texas","Waco"],["University of North Carolina at Chapel Hill","Sheikh Saira","美国","North Carolina","Chapel Hill"],["Penn State University Milton S. Hershey Medical Center","Sciacca Kirby Joslyn","美国","Pennsylvania","Pennsylvania"],["UAB Center for Women's Reproductive Health","Graham Lauren Lauren","美国","Alabama","Birmingham"],["AA MRC LLC Ahmed Arif Medical Research Center","Karrar Ali","美国","Michigan","Grand Blanc"],["Universal Dermatology, PLLC","Poligone Brian","美国","New York","Fairport"],["Duke Dermatology South Durham","Marano Anne","美国","North Carolina","Durham"],["Albuquerque Center For Rheumatology","Pacheco Leroy","美国","New Mexico","Albuquerque Center For Rheumatology"],["Saint Louis University","Hurley M Yadira","美国","Missouri","St. Louis"],["University Hospitals Cleveland Medical Center","Korman Neil","美国","Ohio","Cleveland"],["UTMB Department of Dermatology","Gibson Bernard","美国","Texas","Galveston"],["University of Cincinnati Department of Dermatology","Fleischer Alan","美国","Ohio","Cincinnati"],["University of Massachusetts, Worcester","Rashighi Mehdi","美国","Massachusetts","Worcester"],["University of Nebraska Medical Center","Arthur Megan","美国","Nebraska","Omaha"],["University of Utah Health Sciences Center","Rhoads Jamie","美国","Utah","Murray"],["Columbia University Medical center","Askanase Anca","美国","New York","New York"],["Vanderbilt University Medical Center","Annapureddy Narender","美国","Tennessee","Nashville"],["Denver Arthritis Clinic","Antolini Christopher","美国","Colorado","Denver"],["Metroplex Clinical Research Center, LLC","Cohen Stanley","美国","Texas","Dallas"],["The Regents of the University of California","Kavanaugh Arthur","美国","California","La Jolla"],["West End Dermatology Associates","Knight Yvonne","美国","Virginia","Richmond"],["Precision Comprehensive Clinical Research Solutions","Basu Dhiman","美国","Texas","Grapevine"],["OrthoIllinois","Anand Amrit","美国","Illinois","Elgin"],["Medical Research Center of Miami","Iglesias Nayvis","美国","Florida","Miami"],["Brigham And Women's Hospital","Merola Joseph","美国","Massachusetts","Boston"],["Charisma Medical and Research Center","Rensoli Velazquez Marimer","美国","Florida","Miami Lakes"],["University of New Mexico School of Medicine","Konstantinov Nikifor","美国","New Mexico","Albuquerque"],["Essential Dermatology","Krathen Michael","美国","Massachusetts","Natick"],["Beacon Clinical Research, LLC","Kuohung Victoria","美国","Massachusetts","Quincy"],["Oakland Hills Dermatology","Buatti Christofer","美国","Michigan","Auburn Hills"],["North Texas Center for Clinical Research","Rodgers Timothy","美国","Texas","Frisco"],["University of Texas Health Science Center at Houston","Hebert Adelaide","美国","Texas","Bellaire"],["Tufts Medical Center","Cobos Gabriela","美国","Massachusetts","Boston"],["University of Miami Miller School of Medicine","Maderal Andrea","美国","Florida","Miami"],["University of Florida","Bubb Michael","美国","Florida","Gainesville"],["Rush University Medical Center","Jolly Meenakshi","美国","Illinois","Chicago"],["Kaohsiung Chang Gung Memorial Hospital","Ho Ji-Chen","中国台湾","NA","Kaohsiung"],["Changhua Christian Medical Foundation Changhua Christian Hospital","Tien Ya-Chih","中国台湾","NA","Changhua"],["Taipei Veterans General Hospital","Chang Yun-Ting","中国台湾","NA","Taipei"],["Taichung Veterans General Hospital","Chen Yi-Hsing","中国台湾","NA","Taichung"],["Charite - Campus Charite Mitte","Worm Margitta","德国","Berlin","Berlin"],["Universitaetsklinikum Erlangen","Sticherling Michael","德国","Bayern","Erlangen"],["Universitaetsklinikum Muenster","Steinbrink Kerstin","德国","Nordrhein Westfalen","Muenster"],["Universitaetsklinikum Carl Gustav Carus TU Dresden","Guenther Claudia","德国","Sachsen","Dresden"],["Universitaetsklinikum Bonn AoeR","Wenzel Joerg","德国","Nordrhein Westfalen","Bonn"],["Universitaetsklinikum Schleswig-Holstein - Campus Kiel","Heine Guido","德国","Schleswig Holstein","Kiel"],["Klinikum Oldenburg AoeR","Patsinakidis Nikolaos","德国","Niedersachsen","Oldenburg"],["Universitaetsklinikum Heidelberg","Winkler Julia","德国","Baden Wuerttemberg","Heidelberg"],["Fachklinik Bad Bentheim Dermatologie","Tsianakas Athanasios","德国","Niedersachsen","Bad Bentheim"],["Elbekliniken Buxtehude GmbH","Kleinheinz Andreas","德国","Niedersachsen","Buxtehude"],["Universitaetsklinikum Halle (Saale)","Wohlrab Johannes","德国","Sachsen Anhalt","Halle"],["Universitaetsklinikum Aachen AoeR","Yazdi Amir","德国","Nordrhein Westfalen","Aachen"],["Pecsi Tudomanyegyetem","Hanyecz Anita","匈牙利","NA","Pecs"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","De Simone Clara","意大利","Roma","Roma"],["Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS","La Placa Michelangelo","意大利","Bologna","Bologna"],["Azienda Ospedaliera Universitaria Policlinico Federico II","Nappa Paola","意大利","Napoli","Napoli"],["Ospedale San Raffaele","Dagna Lorenzo","意大利","Milano","Milano"],["Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico","Marzano Angelo Valerio","意大利","Milano","Milano"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Calzavara Pinton Piergiacomo","意大利","Brescia","Brescia"],["Universita degli studi di Firenze","Caproni Marzia","意大利","Firenze","Firenze"],["IRCCS Ospedale Policlinico San Martino","Parodi Aurora","意大利","Genova","Genova"],["Hokkaido University Hospital","Kato Masaru","日本","Hokkaido","Sapporo-shi"],["St. Marianna University Hospital","Kawahata Kimito","日本","Kanagawa-Ken","Kawasaki-shi"],["NHO Nagoya Medical Center","Katayama Masao","日本","Aichi-Ken","Nagoya-shi"],["NHO Osaka Minami Medical Center","Oshima Shiro","日本","Osaka-Fu","Kawachinagano-shi"],["Kanazawa University Hospital","Matsushita Takashi","日本","Ishikawa-Ken","Kanazawa-shi"],["Osaka University Hospital","Fujimoto Manabu","日本","Osaka-Fu","Suita-shi"],["Japanese Red Cross Okayama Hospital","Koyama Yoshinobu","日本","Okayama-Ken","Okayama-shi"],["Tohoku University Hospital","Ishii Tomonori","日本","Miyagi-Ken","Sendai-shi"],["Teikyo University Hospital","Kono Hajime","日本","Tokyo-To","Itabashi-ku"],["Niigata University Medical & Dental Hospital","Hama Natsumi","日本","Niigata-Ken","Niigata-shi"],["University of Fukui Hospital","Hasegawa Minoru","日本","Fukui-Ken","Yoshida-gun"],["Yokohama City University Hospital","Yamaguchi Yukie","日本","Kanagawa-Ken","Yokohama-shi"],["Takatsuki Red Cross Hospital","Shimamoto Junko","日本","Osaka-Fu","Takatsuki-shi"],["JCHO Chukyo Hospital","Kodera Masanari","日本","Aichi-Ken","Nagoya-shi"],["Wakayama Medical University Hospital","Iwata Shigeru","日本","Wakayama-Ken","Wakayama-shi"],["Kumamoto University Hospital","Fukushima Satoshi","日本","Kumamoto-Ken","Kumamoto-shi"],["Kindai University Hospital","Otsuka Atsushi","日本","Osaka-Fu","Osakasayama-shi"],["Kita Harima Medical Center","Misaki Kenta","日本","Hyogo-Ken","Ono-shi"],["Shiga University of Medical Science Hospital","Fujimoto Noriki","日本","Shiga-Ken","Otsu-shi"],["Showa University East Hospital","Yajima Nobuyuki","日本","Tokyo-To","Shinagawa-ku"],["Juntendo University Urayasu Hospital","Morimoto Shinji","日本","Chiba-Ken","Urayasu-shi"],["Shimane University Hospital","Ichinose Kunihiro","日本","Shimane-Ken","Izumo-shi"],["Hospital of the University of Occupational and Environmental Health","Sawada Yu","日本","Kitakyushu-shi","Fukuoka-Ken"],["NHO Yokohama Medical Center","Ihata Atsushi","日本","Kanagawa-Ken","Yokohama-shi"],["Nagasaki University Hospital","Kawakami Atsushi","日本","Nagasaki-Ken","Nagasaki-shi"],["Kakogawa Central City Hospital","Yamane Takashi","日本","Hyogo-Ken","Kakogawa-shi"],["Severance Hospital, Yonsei University Health System","Kim Do Young","韩国","NA","Seoul"],["Hanyang University Seoul Hospital","Ko Joo Yeon","韩国","NA","Suwon"],["Chonnam National University Hospital","Lee Jee Bum","韩国","NA","Gwangju"],["The Catholic University of Korea, Seoul St. Marys Hospital","Park Young Min","韩国","NA","Seoul"],["Korea University Ansan Hospital","Jung Jae Hyun","韩国","Gyeonggi-do","Ansan-si"],["Centro de Investigacion Clínica GRAMEL S.C","Jara Quezada Luis Javier","墨西哥","Distrito Federal","Mexico"],["Consultorio Privado Dr. Miguel Cortes Hernandez","Cortes Hernandez Miguel","墨西哥","Morelos","Cuernavaca"],["Derma Norte del Bajio S.C.","Poletti Vazquez Eduardo","墨西哥","Aguascalientes","Aguascalientes"],["Medical Care & Research SA de CV","Barrera Rodriguez Aaron Alejandro","墨西哥","Yucatan","Merida"],["Investigacion y Biomedicina de Chihuahua, S.C.","Pacheco Tena Cesar Francisco","墨西哥","Chihuahua","Chihuahua"],["Centro Regiomontano de Estudios Clínicos Roma S.C.","Colunga Pedraza Iris","墨西哥","Nuevo Leon","Monterrey"],["Centro de investigacion medica y reumatologia","Aguilar Arreola Jorge Enrique","墨西哥","Jalisco","Guadalajara"],["Clinstile, S.A. de C.V.","Enriquez Sosa Favio Edmundo","墨西哥","Distrito Federal","Ciudad de Mexico"],["Invest Clinicas Sac Inst de Ginecologia y Reproduccion","Calderon Gallegos Julia Elena","秘鲁","NA","Lima"],["Clinica San Felipe - Centro de Investigacion Clinica Inmunoreumatologia","Calvo Quiroz Armando","秘鲁","NA","Lima"],["Far Eastern University - Dr. Nicanor Reyes Medical Foundation","Baes Rosario","菲律宾","NA","Quezon City, Metro Manila"],["Mary Mediatrix Medical Center","Lanzon Allan","菲律宾","NA","Lipa"],["Philippine General Hospital","Manapat Reyes Bernadette Heizel","菲律宾","NA","Manila"],["Medical Center Manila","Tee Michael","菲律宾","NA","Manila"],["Cebu Doctors University Hospital","Barba Merle","菲律宾","NA","Cebu City"],["St. Lukes Medical Center","Lichauco Juan Javier","菲律宾","NA","Quezon City"],["Jose R. Reyes Memorial Medical Center","Roberto Linda Charmaine","菲律宾","NA","Manila"],["The Medical City Clark","Villanueva Misa","菲律宾","NA","Mabalacat, Pampanga"],["Ilocos Training and Regional Medical Center","Corpuz Allan","菲律宾","NA","San Fenando, La Union"],["Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski","Brzewski Pawel","波兰","NA","Krakow"],["Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak","Narbutt Joanna","波兰","NA","Lodz"],["Ajou University Hospital","Suh Chang-Hee","日本","NA","Suwon"],["Keio University Hospital","Ouchi Takeshi","日本","Tokyo-To","Shinjuku-ku"],["Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spoika Partnerska","Szepietowski Jacek","波兰","NA","Wroclaw"],["Royalderm","Owczarek Witold","波兰","NA","Warszawa"],["SPZOZ Szpital Uniwersytecki w Krakowie","Wojas-Pelc Anna","波兰","NA","Krakow"],["Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina","Reich Adam","波兰","NA","Rzeszow"],["Szpital Kliniczny Dzieciatka Jezus","Rudnicka Lidia","波兰","NA","Warszawa"],["Hospital CUF Descobertas","Mendes Bastos Pedro","葡萄牙","NA","Lisboa"],["Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)","Goncalo Margarida","葡萄牙","NA","Coimbra"],["Centro Hospitalar Universitártio do Porto, E.P.E.","Azevedo Alexandra","葡萄牙","NA","Porto"],["Hospital de Egas Moniz","Pimentel Dos Santos Fernando","葡萄牙","NA","Lisboa"],["Unidade Local de Saude do Alto Minho, E.P.E.","Teixeira Vera","葡萄牙","NA","Viana do Castelo"],["Dr. Samuel Sanchez PSC","Sanchez Rivera Samuel","波多黎各","NA","Caguas"],["GCM Medical Group PSC - Hato Rey","Gonzalez Chavez Jose R","波多黎各","NA","San Juan"],["King Saud University","Almaghlouth Ibrahim","沙特阿拉伯","NA","Riyadh"],["King Faisal Specialist Hospital & Research Center","Binamer Yousef","沙特阿拉伯","NA","Riyadh"],["Institute of Rheumatology","Radunovic Goran","塞尔维亚","NA","Belgrade"],["Clinical Center of Vojvodina","Vujanovic Ljuba","塞尔维亚","NA","Novi Sad"],["University Clinical Center of Serbia","Arandjelovic Snezana","塞尔维亚","NA","Belgrade"],["Narodny ustav reumatickych chorob","Lukacova Olga","斯洛伐克","NA","Piestany"],["Artromac n.o.","Macejova Zelmira","斯洛伐克","NA","Kosice"],["Hospital Universitario Rio Hortega","Barbado Ajo Maria Julia","西班牙","Valladolid","Valladolid"],["Hospital Universitari Germans Trias i Pujol","Bielsa Marsol Isabel","西班牙","Badalona","Badalona"],["Hospital de la Santa Creu i Sant Pau","Roe Crespo Esther","西班牙","Barcelona","Barcelona"],["Complejo Hospitalario Universitario A Coruna","Blanco Garcia Francisco Javier","西班牙","La Coruna","Coruna"],["Hospital Universitario Puerta de Hierro Majadahonda","Cabeza Martinez Rita","西班牙","Madrid","Majadahonda"],["Hospital Universitario Reina Sofia","Ruano Ruiz Juan Alberto","西班牙","Cordoba","Cordoba"],["Hospital Universitario Fundacion Alcorcon","Lopez Estebaranz Jose Luis","西班牙","Madrid","Alcorcon"],["Hospital Universitario Virgen del Rocio","Garrido Punal Noemi Patricia","西班牙","Sevilla","Sevilla"],["Hospital del Mar","Pujol Vallverdu Ramon Maria","西班牙","Barcelona","Barcelona"],["Karolinska Universitetssjukhuset - Solna","Nyberg Filippa","瑞典","NA","Stockholm"],["Centre Hospitalier Universitaire Vaudois (CHUV)","Gilliet Michel","瑞士","NA","Lausanne"],["Kantonsspital St. Gallen","Cozzio Antonio","瑞士","NA","St. Gallen"],["Universitaetsspital Zuerich","Kolios Antonios","瑞士","NA","Zurich-Flughafen"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院皮肤病医院（研究所）医学伦理委员会","同意","2024-06-07"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 30 ； 国际: 322 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 63 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2023-10-03；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2023-10-04；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；