北京注射用DapirolizumabPegol单抗III期临床试验-一项旨在评估系统性红斑狼疮研究受试者接受dapirolizumab pegol治疗的长期安全性和耐受性的多中心、开放性扩展研究

北京中国医学科学院北京协和医院开展的注射用DapirolizumabPegol单抗III期临床试验信息，需要患者受试者,主要适应症为系统性红斑狼疮

上一个试验目前是第 19208 个试验/共 19731 个试验下一个试验

基本信息

登记号	CTR20250559	试验状态	进行中
申请人联系人	李草草	首次公示信息日期	2025-02-18
申请人名称	---/ 优时比贸易（上海）有限公司

登记号	CTR20250559
相关登记号	CTR20222715
药物名称	注射用Dapirolizumab Pegol单抗
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	系统性红斑狼疮
试验专业题目	一项旨在评估系统性红斑狼疮研究受试者接受dapirolizumab pegol治疗的长期安全性和耐受性的多中心、开放性扩展研究
试验通俗题目	一项旨在评估系统性红斑狼疮研究受试者接受dapirolizumab pegol治疗的长期安全性和耐受性的多中心、开放性扩展研究
试验方案编号	SL0046	方案最新版本号	修正案2.3
版本日期:	2024-07-04	方案是否为联合用药	否

申请人名称	[["---"],["优时比贸易（上海）有限公司"]]
联系人姓名	李草草	联系人座机	021-23120436	联系人手机号	18616717023
联系人Email	celia.li@ucb.com	联系人邮政地址	上海市-上海市-中国（上海）自由贸易试验区富特西一路439号317室	联系人邮编	200137

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

[["到第24周的重度BILAG发作预防（无重度BILAG发作）的实现率","第24周","有效性指标"],["到第52周的重度BILAG发作预防（无重度BILAG发作）的实现率","第52周","有效性指标"],["到第104周的重度BILAG发作预防（无重度BILAG发作）的实现率","第104周","有效性指标"],["≥ 50%的访视达到LLDAS","从基线期（第1天）至第104周","有效性指标"],["第24周的BICLA应答维持率","第24周","有效性指标"],["第52周的BICLA应答维持率","第52周","有效性指标"],["第104周的BICLA应答维持率","第104周","有效性指标"]]

序号	指标	评价时间	终点指标选择

四、研究者信息

1、主要研究者信息

1	姓名	曾小峰	学位	医学博士	职称	主任医师
	电话	13501069845	Email	xiaofeng.zeng@cstar.org.cn	邮政地址	北京市-北京市-西城区大木仓胡同41号
	邮编	100032	单位名称	中国医学科学院北京协和医院

2、各参加机构信息

[["中国医学科学院北京协和医院","曾小峰","中国","北京市","北京市"],["中山大学附属第三医院","古洁若","中国","广东省","广州市"],["南京医科大学第一附属医院（江苏省人民医院）","顾镭","中国","江苏省","南京市"],["西安交通大学第一附属医院","何岚","中国","陕西省","西安市"],["山东大学齐鲁医院","宋立军","中国","山东省","济南市"],["苏州大学附属第一医院","武剑","中国","江苏省","苏州市"],["天津医科大学总医院","魏蔚","中国","天津市","天津市"],["北京大学第一医院","张卓莉","中国","北京市","北京市"],["复旦大学附属华山医院","万伟国","中国","上海市","上海市"],["桂林医学院附属医院","李宝贞","中国","广西壮族自治区","桂林市"],["新疆维吾尔自治区人民医院","武丽君","中国","新疆维吾尔自治区","乌鲁木齐市"],["温州医科大学附属第一医院","孙莉","中国","浙江省","温州市"],["吉林大学第一医院","姜振宇","中国","吉林省","长春市"],["郑州大学第一附属医院","刘升云","中国","河南省","郑州市"],["华中科技大学同济医学院附属同济医院","董凌莉","中国","湖北省","武汉市"],["华中科技大学同济医学院附属协和医院","黄安斌","中国","湖北省","武汉市"],["蚌埠医学院第一附属医院","谢长好","中国","安徽省","蚌埠市"],["上海交通大学医学院附属仁济医院","吕良敬","中国","上海市","上海市"],["常州市第一人民医院","吴敏","中国","江苏省","常州市"],["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"],["中山大学孙逸仙纪念医院","郑东辉","中国","广东省","广州市"],["北京大学第三医院","穆荣","中国","北京市","北京市"],["南昌大学第二附属医院","段新旺","中国","江西省","南昌市"],["苏北人民医院","魏华","中国","江苏省","扬州市"],["中南大学湘雅医院","罗卉","中国","湖南省","长沙市"],["海南省人民医院","詹锋","中国","海南省","海口市"],["浙江省人民医院","李涯松","中国","浙江省","杭州市"],["江西省萍乡市人民医院","胡建康","中国","江西省","萍乡市"],["Aprillus Asistencia e Investigacion Clinica","Mannucci, Pablo","阿根廷","Ciudad Autonoma de Buenos Aire","Buenos Aires"],["Instituto Medico CER","Velasco Zamora, Jorge","阿根廷","Buenos Aires","Quilmes"],["Hospital Jose Maria Ramos Mejia","Kerzberg, Eduardo","阿根廷","Ciudad Autonoma de Buenos Aire","C.A.B.A"],["Centro de Investigaciones Medicas Tucuman","Spindler, Alberto","阿根廷","Tucuman","Tucuman"],["Instituto de Investigaciones Clinicas Quilmes","Velasco Zamora, Jose","阿根廷","Buenos Aires","Quilmes"],["Hospital Cordoba - Reumatology","Savio, Veronica","阿根廷","Cordoba","Cordoba -"],["Instituto de Reumatologia - Borgia Alfredo Luis","Borgia, Alfredo Luis","阿根廷","Mendoza","Mendoza"],["Ordensklinikum Linz GmbH - Dermatology","Geroldinger-Simic, Marija","奥地利","Oberosterreich","Linz"],["AKH Wien","Machold, Klaus","奥地利","Wien","Wien"],["LKH-Univ. Klinikum Graz","Stradner, Martin","奥地利","Steiermark","Graz"],["CHU de Liege - Domaine Universitaire du Sart Tilman","Von Frenckell, Christian","比利时","Liege","Liege"],["Hopital Erasme","Soyfoo, Muhammad","比利时","Brussels Capital Region","Bruxelles"],["CHU Brugmann - Victor Horta","Badot, Valerie","比利时","Brussels Capital Region","Bruxelles"],["Toronto Western Hospital","Touma, Zahi","加拿大","Ontario","Toronto"],["Centre integre de sante et de services sociaux du Bas-Saint-Laurent (CISSSBSL) Hopital regional de Rimouski - Research","Fortin, Isabelle","加拿大","Quebec","Rimouski"],["Mcgill Univ Health Center","Pineau, Christian","加拿大","Quebec","Montreal"],["University Of Alberta Hospital","Keeling, Stephanie","加拿大","Alberta","Edmonton"],["University of Calgary","Clarke, Ann","加拿大","Alberta","Calgary"],["Clinica Dermacross, S.A","De la Cruz Fernandez, Claudia","智利","Region Metropolitana de Santia","Santiago de Chile"],["Centro Medico Prosalud","Goecke Sariego, Irmgadt","智利","Region Metropolitana de Santia","Santiago"],["INTERIN","Soto, Lilian","智利","Region Metropolitana de Santia","Providencia, Santiago"],["Biomedica Research Group","Moreno Goio, Elizabeth","智利","Region Metropolitana de Santia","Santiago"],["Rigshospitalet Copenhagen University Hospital","Jacobsen, Soren","丹麦","Capital","Copenhagen"],["CHU Hopital de Hautepierre","ARNAUD, Laurent","法国","Bas-Rhin","Strasbourg"],["AP-HP","Fain, Olivier","法国","Paris","Paris"],["Hopital Lapeyronie - Departement de Rhumatologie po","Duffau, Pierre","法国","Herault","Montpellier"],["Centre Hospitalier Universitaire De Bordeaux - Hopital Saint - Medecine Interne Et Des Maladi","Duffau, Pierre","法国","Gironde","Bordeaux"],["Hopital Pellegrin","Richez, Christophe","法国","Gironde","Bordeaux"],["St. Elisabeth Gruppe GmbH - Katholische Kliniken Rhein- Ruhr, Rheumazentrum Ruhrgebiet","Ioana Andreica","德国","Nordrhein-Westfalen","Herne"],["Universitatsklinikum Freiburg","Finzel, Stephanie","德国","Baden-Württemberg","Freiburg"],["Universitatsklinikum Leipzig AoR","Wagner, Ulf","德国","Sachsen","Leipzig"],["Universitatsmedizin der Johannes-Gutenberg-Universitat Mainz","Schwarting Kaluza-Schilling, Wiebke","德国","Rheinland-Pfalz","Mainz"],["Stadtisches Klinikum Dessau","Zouboulis, Christos","德国","Sachsen-Anhalt","Dessau"],["Universitatsklinikum Carl Gustav Carus","Aringer, Martin","德国","Sachsen","Dresden"],["Universitatsklinikum Koln","Kofler, David","德国","Nordrhein-Westfalen","Cologne"],["CIRI GmbH","Behrens, Frank","德国","Bayern","Frankfurt"],["Schlosspark-Klinik - Zentrum fur Rheumaforschung","Alten, Rieke","德国","Berlin","Berlin"],["Ippokrateio Hospital of Thessaloniki","Garyfallos, Alexandros","希腊","Kentriki Makedonia","Thessaloniki"],["Laikon","SFIKAKIS, Petros","希腊","Athens","Athens"],["University Hospital of Crete PAGNI","Sidiropoulos, Prodromos","希腊","Irakleio","Crete"],["Hippokration Hospital Athens","Vasilopoulos, Dimitrios","希腊","Athens","Athens"],["University of Patras - Rio Regional University Hospital","Liossis, Stamatis-Nick","希腊","Patras","Patras"],["General Hospital of Athens","Boumpas, Dimitrios","希腊","Athens","Athens"],["University Hospital Of Larissa","Katsiari, Christina","希腊","Larisa","Larisa"],["Queen Mary Hospital - Medicine","Chan, Daniel Tak-mao","中国香港","香港","香港"],["PO S.Marco, AOU Policlinico-Vittorio Emanuele Catania","Foti, Rosario","意大利","Catania","Catania"],["Polo Universita degli Studi di Milano - Ospedale Luigi Sacco","Sarzi-Puttini, Piercarlo","意大利","Lombardia","Milan"],["Policlinico Universitario Gemelli","Gremese, Elisa","意大利","Lazio","Roma"],["AOU Pisana","Mosca, Marta","意大利","Pisa","Pisa"],["Policlinico di Milano","Beretta, Lorenzo","意大利","Milano","Milano"],["Ospedale San Raffaele, IRCCS","Dagna, Lorenzo","意大利","Milano","Milano"],["AO G.Pini, Istituto Ortopedico","Gerosa","意大利","Milano","Milano"],["Arcispedale S.Anna, AOU di Ferrara","Govoni, Marcello","意大利","Ferrara","Ferrara"],["Policlinico G. B. Rossi","Orsolini","意大利","Verona","Verona"],["AOU di Padova","Zen, Margherita","意大利","Padova","Padova"],["DiMI, Dipartimento di Medicina interna e Specialita mediche,","Cutolo, Maurizio","意大利","Genova","Genova"],["Ajou University Hospital - Rheumatology","Suh, Chang-Hee","韩国","Suwon","Suwon"],["Seoul National University Hospital - Rheumatology","Lee, Eun Bong","韩国","Seoul Teugbyeolsi [Seoul-T'ukp","Seoul"],["Dong-A University Hospital","Lee, Sung Won","韩国","Lima","Lima"],["Unidad de Investigacion de Reumatologia e Inmunologia CSJB","Ravelo Hernandez, Jorge","秘鲁","Lima","Lima"],["Instituto de Ginecología y Reproduccion","Leon Portocarrero, Manuel","秘鲁","Lima","Lima"],["Hospital Nacional Cayetano Heredia","Zuniga Corrales, Katiuzka","秘鲁","Lima","Lima"],["Instituto Peruano del Hueso y la Articulación","Romero Pena, Felix","秘鲁","Lima","Lima"],["Hogar Clínica San Juan de Dios. Unidad de Investigacion en M","Bellatin Vargas, Luis","秘鲁","Arequipa","Arequipa"],["Medycyna Kliniczna","Zielinska, Agnieszka","波兰","Mazowieckie","Warszawa"],["Reumatika-Centrum Reumatologii, NZOZ","Zubrzycka - Sienkiewicz, Anna","波兰","Mazowieckie","Warszawa"],["Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie","Majdan, Maria","波兰","Lublin","Lublin"],["Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji","Olesinska, Marzena","波兰","Mazowieckie","Warszawa"],["Centrum Medyczne Pratia Katowice","Dziewit, Tomasz","波兰","Katowice","Katowice"],["Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego","Wiland, Piotr","波兰","Wroclaw","Wroclaw"],["Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. W. Degi UM w Poznaniu","Samborski, Wlodzimierz","波兰","Poznan","Poznan"],["Pratia MCM Krakow","Korkosz, Mariusz","波兰","Krakow","Krakow"],["Centrum Medyczne Plejady","Celinska - Lowenhoff, Magdalena","波兰","Krakow","Krakow"],["C.H. de Vila Nova de Gaia/Espinho","Pinto, Patricia","葡萄牙","Porto","Vila Nova de Gaia"],["H. Conde de Bertiandos. Centro Hospitalar do Alto Minho","Faria, Daniela","葡萄牙","Viana do Castelo","Ponte de Lima"],["Centro Hospitalar de Leiria","Rodrigues, Marília","葡萄牙","Leiria","Leiria"],["Hospitais Da Universidade de Coimbra","Ines, Luis","葡萄牙","Coimbra","Coimbra"],["H. Santa Maria. Centro Hospitalar Lisboa Norte","Khmelinskii, Nikita","葡萄牙","Lisboa","Lisboa"],["Clinical Center Of Vojvodina","Mitic, Igor","塞尔维亚","Vojvodina","Novi Sad"],["Institute for Rheumatology","Radunovic, Goran","塞尔维亚","Belgrade","Belgrade"],["Military Medical Academy","Petronijevic, Milan","塞尔维亚","Belgrade","Belgrade"],["Clinical Center Kragujevac","Tomic Lucic, Aleksandra","塞尔维亚","Sumadijski okrug","Kragujevac"],["C.H.U. A Coruna","Freire Gonzalez, Mercedes","西班牙","Galicia","Coruna"],["Hospital Universitario Vall d'Hebron","Cortes Hernandez, Josefina","西班牙","Barcelona","Barcelona"],["H. Civil de Malaga","Fernandez Nebro, Antonio","西班牙","Malaga","Malaga"],["H.U.V.Arrixaca","Marras Fernandez Cid, Carlos","西班牙","Murcia","Murcia"],["Hospital Quironsalud Sagrado Corazo","Morote Ibarrola, Guadalupe","西班牙","Sevilla","Sevilla"],["Hospital Universitario de Canarias","Diaz Gonzalez, Federico","西班牙","Santa Cruz de Tenerife","San Cristobal de La Laguna"],["Hospital de Merida","Chamizo Carmona, Eugenio","西班牙","Badajoz","Merida"],["Taipei Veterans General Hospital - Allergy, Immunology and Rheuma","蔡長祐","中国台湾","台湾","台北"],["Tri-Service General Hospital - Neihu Branch - Rheumatology","陳相成","中国台湾","台湾","台北"],["Taichung Veterans General Hospital","陳怡行","中国台湾","台湾","台中"],["The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit","Vila, Josie","英国","Newcastle upon Tyne","Newcastle upon Tyne"],["Guy's and St Thomas NHS Trust","D'Cruz, David","英国","London","London"],["University College London Hospitals","Castelino, Madhura","英国","London","London"],["West Tennessee Research Institute","Aelion, Jacob","美国","Tennessee","Jackson"],["NYU Langone Ambulatory Care Brooklyn Heights","Goddard, David","美国","New York","Brooklyn"],["Klein & Associates, M.D., P.A.","Howell, Mary","美国","Maryland","Hagerstown"],["Altoona Center for Clinical Research - Research","Kivitz, Alan","美国","Pennsylvania","Duncansville"],["Southwest Rheumatology Research LLC","Singhal, Atul","美国","Texas","Mesquite"],["Arizona Arthritis & Rheumatology Research, PLLC - Rheumatology","Bennett, Ralph","美国","Arizona","Phoenix"],["Metroplex Clinical Research Center","Fallena, Margarita","美国","Texas","Dallas"],["Arthritis Northwest, PLLC","Kenney, Howard","美国","Washington","Spokane"],["Hospital for Special Surgery","Kirou, Kyriakos","美国","New York","New York"],["University of Alabama at Birmingham","Chatham, Walter","美国","Alabama","Birmingham"],["Penn State Milton S Hershey Medical Center Pediatrics","Olsen, Nancy","美国","Pennsylvania","Hershey"],["Wake Forest School of Medicine - Department of Rheumatology","Thapa, Rupak","美国","North Carolina-Winston","Salem"],["Wayne State University / Detroit Receiving Hospital","Sarakbi, Housam","美国","Michigan","Detroit"],["DJL Clinical Research, PLLC","Box, Emily Jane","美国","North Carolina","Charlotte"],["Bay Area Arthritis And Osteoporosis","Joshi, Vipul","美国","Florida","Brandon"],["Institute of Arthritis Research","Scoville, Craig","美国","Idaho","Idaho Falls"],["SUNY Upstate Medical University","Perl, Andras","美国","New York","Syracuse"],["Bronx-Lebanon Hospital Center","Franchin, Giovanni","美国","New York","Bronx"],["University of California San Diego School of Medicine","Kalunian, Kenneth","美国","California","La Jolla"],["Academic Medical Research Institute (AMRI)","El-Shahawy, Mohamed","美国","California","Los Angeles"],["Oklahoma Medical Research Foundation","Arriens, Cristina","美国","Oklahoma","Oklahoma City"],["Amarillo Center for Clinical Research, Ltd.","Saadeh, Constantine","美国","Texas","Amarillo"],["The Feinstein Institute for Medical Research","Aranow, Cynthia","美国","New York","Manhasset"],["Northwell Health/ Division of Rheumatology","Furie, Richard","美国","New York","Great Neck"],["University Of Washington Medical Ctr","Han, Kwanghoon","美国","Washington","Seattle"],["Innovative Health Research","Kelly, George","美国","Nevada","Las Vegas"],["Arthritis & Osteoporosis Medical Center, Inc. - La Palma","Ho, Gerald","美国","California","La Palma"],["Childrens Hospital Los Angeles","Haro (formerly Marzan, Katherine)","美国","California","Los Angeles"],["Graves-Gilbert Clinic - Bowling Green","Fraser, Asad","美国","Kentucky","Bowling Green"],["Accurate Clinical Research, Inc.","Mendez, Enrique","美国","Louisiana","Lake Charles"],["Klein and Associates, M.D., P.A.","Klein, Steven","美国","Maryland","Cumberland"],["UT Southwestern Medical Center","Karp, David","美国","Texas","Dallas"],["Rush University Medical Center","Nika, Ailda","美国","Illinois","Chicago"],["Duke Medical Center","Clowse, Megan","美国","North Carolina","Durham"],["East Bay Rheumatology Medical Group, Inc.","Neuwelt, Clark","美国","California","San Leandro"],["University of California San Diego","Chiraseveenuprapund, Peter","美国","California","San Diego"],["West Virginia University Hospitals","Ladani, Amit","美国","West Virginia","Morgantown"],["Arthritis and Rheumatology Center of Oklahoma, PLLC","Khan, Mohammad","美国","Oklahoma","Oklahoma City"],["Intergral Rheumatology & Immunology Specialist","Valenzuela, Guillermo","美国","Florida","Plantation"],["Center for Arthritis and Rheumatic Diseases","LaConti, Joseph","美国","Florida","Miami"],["AA Medical Research Center LLC","Karrar, Ali","美国","Michigan","Grand Blanc"],["Columbia University Medical Center","Askanase, Anca","美国","New York","New York"],["Mt. Olympus Medical Research","Yousaf Bhatt","美国","Texas","Bellaire"],["Denver Arthritis Clinic","Antolini, Christopher","美国","Colorado","Denver"],["University of California, Irvine","Desai, Sheetal","美国","California","Orange"],["Howard University Hospital","Dowell, Sharon","美国","District of Columbia","Washington"],["Clinic of Robert Hozman","Hozman, Robert","美国","Illinois","Skokie"],["Kaiser Permanente","Lee, Steve","美国","California","Fontana"],["UF Health Rheumatology","Bubb, Michael","美国","Florida","Gainesville"],["The Children's Hospital of Philadelphia (CHOP)","Mehta Chang","美国","Pennsylvania","Philadelphia"],["Thomas Jefferson University","Kiriakidou, Marianthi","美国","Pennsylvania","Philadelphia"],["UPMC","Coca (formerly Liang, Kimberly)","美国","Pennsylvania","Pittsburgh"],["St. Lawrence Health System Medical Campus","Kedar, Eyal","美国","New York","Canton"],["Yale Center for Clinical Investigation - Delivery","Koumpouras, Fotios","美国","Connecticut","New Haven"],["EMORY UNIVERSITY","Lim, Sung","美国","Georgia","Atlanta"],["TriWest Research Associates, LLC.","Dikranian, Ara","美国","California","San Diego"],["Loma Linda University - Rheumatology","Sandhu, Vaneet","美国","California","Loma Linda"],["Piedmont Healthcare","Machua, Wambui","美国","Georgia","Atlanta"],["Wallace Rheumatic Studies Center","Wallace, Daniel","美国","California","Beverly Hills"],["Precision Comprehensive Clinical Research Solutions","Basu, Dhiman","美国","Texas","Colleyville"],["Rheumatology Associates of Central Florida","Freeman, Pamela","美国","Florida","Orlando"],["Arthritis and Rheumatic Disease Specialties - Rheumatology","Gaylis, Norman","美国","Florida","Aventura"],["Western KY Rheumatology, PLLC","Desai, Kishorkumar","美国","Kentucky","Hopkinsville"],["University of Miami Miller School of Medicine - Department o","Carpintero-Ramirez, Maria","美国","Florida","Miami"],["University of Fukui Hospital","Minoru Hasegawa","日本","Yoshida-gun","Yoshida-gun"],["Osaka University Hospital","Atsushi Kumanogoh","日本","Osaka","Suita"],["Manabu Fujimoto","Osaka University Hospital - Dermatology","日本","Osaka","Suita"],["Mie University Hospital - Rheumatology","Ayako Nakajima","日本","Mie","Tsu"],["Nippon Medical School Hospital - Dermatology","Masataka Kuwana","日本","Tokyo","Bunkyo-ku"],["National Hospital Organization Nagoya Medical Center - Hematology","Masao Katayama","日本","Aiti [Aichi]","Nagoya"],["Nagasaki University Hospital - Rheumatology","Atsushi Kawakami","日本","Nagasaki","Nagasaki"],["Eiraku Clinic - Rheumatology","Nobutaka Eiraku","日本","Kagosima [Kagoshima]","Kagoshima"],["Toho University Medical Center Ohashi Hospital - Rheumatology","Hideto Kameda","日本","Tokyo","Meguro-ku"],["Hospital of the University of Occupational and Environmental Health","Yoshiya Tanaka","日本","Kitakyushu","Kitakyushu"],["Saitama Medical University Saitama Medical Center - Rheumatology/Collagen disease","Koichi Amano","日本","Saitama","Kawagoe"],["Hamanomachi Hospital - Rheumatology","Seiji Yoshizawa","日本","Hukuoka [Fukuoka]","Fukuoka"],["Kyushu Medical Center - Rheumatology","Tomoya Miyamura","日本","Hukuoka [Fukuoka]","Fukuoka"],["Kitasato University Hospital Rheumatology and Infectious Diseases","Kunihiro Yamaoka","日本","Kitasato University Hospital","Kitasato University Hospital"],["Kagawa University Hospital - Internal Medicine","Hiroaki Dobashi","日本","Kita-gun","Kita-gun"],["Saga University Hospital - Rheumatology","Yoshifumi Tada","日本","Saga","Saga"],["Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital - Rheumatology","Takuya Sawabe","日本","Hirosima [Hiroshima]","Hiroshima"],["The University of Tokyo Hospital - Allergy and Rheumatology","Keishi Fujio","日本","Tokyo","Bunkyo-ku"],["Tokyo Women's Medical University Hospital","Yasuhiro Katsumata","日本","Tokyo","Shinjuku-ku"],["St. Luke's International Hospital - Dermatology","Yukihiko Ikeda","日本","Tokyo","Chuo-ku"],["Juntendo University Hospital","Dr. Kentaro Minowa","日本","Bunkyo-ku","Bunkyo-ku"],["Kurashiki Medical Center - Rheumatology","Yasuhiko Yoshinaga","日本","Hokkaido","Sapporo"],["JCHO Chukyo Hospital - Dermatology","Masanari Kodera","日本","Aiti [Aichi]","Nagoya"],["Keio University Hospital - Rheumatology","Yuko Kaneko or Dr. Jun Kikuchi","日本","Tokyo","Shinjuku-ku"],["Sasebo Chuo Hospital - Internal Medicine","Yukitaka Ueki","日本","Nagasaki","Sasebo"],["National Center for Global Health and Medicine - Rheumatology","Hiroshi Kaneko","日本","Tokyo","Shinjuku-ku"],["Osaka University Hospital -Rheumatology","Dr. Yasuhiro Kato","日本","Osaka","Suita"],["Hokkaido University Hospital","Dr. Tatsuya Atsumi","日本","Hokkaido","Sapporo"]]

序号	机构名称	主要研究者	国家	省（州）	城市

五、伦理委员会信息

[["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2024-10-28"]]

序号	名称	审查结论	批准日期/备案日期

六、试验状态信息

1、试验状态

进行中（尚未招募）

2、试验人数

目标入组人数	国内: 57 ；国际: 760 ；
已入组人数	国内: 登记人暂未填写该信息；国际: 233 ；
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；

3、受试者招募及试验完成日期

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：2021-07-27；
第一例受试者入组日期	国内：登记人暂未填写该信息；国际：2021-07-27；
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；

上一个试验目前是第 19208 个试验/共 19731 个试验下一个试验

北京注射用DapirolizumabPegol单抗III期临床试验-一项旨在评估系统性红斑狼疮研究受试者接受dapirolizumab pegol治疗的长期安全性和耐受性的多中心、开放性扩展研究

基本信息

公示的试验信息