北京MK-7240II期临床试验-在放射学阳性中轴型脊柱关节炎成人中评价Tulisokibart的Ⅱb期研究

登记号	CTR20254031	试验状态	进行中
申请人联系人	秦琰雯	首次公示信息日期	2025-10-10
申请人名称	Merck Sharp & Dohme LLC/ 默沙东研发（中国）有限公司/ Catalent Indiana, LLC

登记号	CTR20254031
相关登记号	暂无
药物名称	MK-7240
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	放射学阳性中轴型脊柱关节炎
试验专业题目	一项在放射学阳性中轴型脊柱关节炎（强直性脊柱炎）受试者中评价Tulisokibart有效性和安全性的Ⅱb期、随机、双盲、安慰剂对照研究
试验通俗题目	在放射学阳性中轴型脊柱关节炎成人中评价Tulisokibart的Ⅱb期研究
试验方案编号	MK-7240-013	方案最新版本号	01
版本日期:	2025-07-07	方案是否为联合用药	否

申请人名称	[["Merck Sharp & Dohme LLC"],["默沙东研发（中国）有限公司"],["Catalent Indiana, LLC"]]
联系人姓名	秦琰雯	联系人座机	010-58609758	联系人手机号	15198257906
联系人Email	yan.wen.qin@msd.com	联系人邮政地址	北京市-北京市-朝阳区容达路21号	联系人邮编	100012

评估tulisokibart在18-80岁活动性r-axSpA受试者中的有效性、安全性和耐受性。

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

年龄	18岁(最小年龄)至 80岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["临床诊断为axSpA，符合axSpA的ASAS分类标准，包括≥3个月的背痛，症状发作时年龄 < 45岁。"],["筛选时中心阅片确定符合修订的纽约AS标准的放射学标准。"],["筛选和随机分组时存在活动性疾病。"],["对NSAID应答不佳/不耐受且对bDMARD没有应答不佳或不耐受；既往对bDMARD应答不加或不耐受（最多2类）。"]]
排除标准	[["患有关节炎（17岁前发病）或当前诊断为除r-axSpA以外的炎性关节疾病（例如但不限于类风湿性关节炎、系统性红斑狼疮、PsA、系统性硬化症、肌炎等），或根据研究者的判断可能干扰r-axSpA评估的任何其他疾病。"],["有癌症史（完全治愈的非黑色素瘤皮肤癌或完全手术切除后的宫颈原位癌除外），且在随机分组前无疾病时间不足5年。"],["患有任何活动性感染。"],["已知对tulisokibart或其辅料过敏、发生过超敏反应或不耐受。"]]

试验药	[["中文通用名:MK-7240 英文通用名:MK-7240 商品名称:NA","剂型:注射剂 规格:信息涉及专利，不披露 用法用量:皮下注射，高剂量 用药时程:最长140周"],["中文通用名:MK-7240 英文通用名:MK-7240 商品名称:NA","剂型:注射剂 规格:信息涉及专利，不披露 用法用量:皮下注射，中剂量 用药时程:最长140周"],["中文通用名:MK-7240 英文通用名:MK-7240 商品名称:NA","剂型:注射剂 规格:信息涉及专利，不披露 用法用量:皮下注射，低剂量 用药时程:16周"]] 序号 名称 用法
对照药	[["中文通用名:MK-7240的安慰剂 英文通用名:PlaceboofMK-7240 商品名称:NA","剂型:注射剂（醋酸钠三水合物，醋酸，氯化钠，蔗糖，聚山梨酯20，注射用水） 规格:0mg/ml 用法用量:皮下注射 用药时程:16周"]] 序号 名称 用法

主要终点指标及评价时间	[["达到ASAS 40应答的受试者比例","16周","有效性指标"]] 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	[["达到ASDAS<2.1的受试者比例","16周","有效性指标"],["BASFI较基线的变化","16周","有效性指标"],["脊柱的SPARCC MRI评分较基线的变化","16周","有效性指标"],["SIJ的SPARCC MRI评分较基线的变化","16周","有效性指标"],["QoL较基线的变化","16周","有效性指标"],["BASDAI较基线的变化","16周","有效性指标"],["基线存在附着点炎的受试者亚组中MASES较基线的变化","16周","有效性指标"],["BASMIlin较基线的变化","16周","有效性指标"],["FACIT-疲劳较基线的变化","16周","有效性指标"],["Tulisokibart的安全性和耐受性","16周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	李梦涛	学位	博士	职称	主任医师
	电话	010-69159966	Email	Mengtao.li@cstar.org.cn	邮政地址	北京市-北京市-东城区帅府园1号北京协和医院东院
	邮编	100730	单位名称	中国医学科学院北京协和医院

[["中国医学科学院北京协和医院","李梦涛 田新平","中国","北京市","北京市"],["中山大学附属第三医院","潘云峰","中国","广东省","广州市"],["昆明医科大学第一附属医院","徐健","中国","云南省","昆明市"],["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"],["广东省人民医院","李洋","中国","广东省","广州市"],["河南科技大学第一附属医院","史晓飞","中国","河南省","洛阳市"],["萍乡市人民医院","胡建康","中国","江西省","萍乡市"],["蚌埠医学院第一附属医院","李志军","中国","安徽省","蚌埠市"],["吉林大学第一医院","赵令","中国","吉林省","长春市"],["Advanced Rheumatology of Houston","Tamar Brionez","美国","TX","The Woodlands"],["Inland Rheumatology Clinical Trials, Inc.","Eric Lee","美国","CA","Upland"],["Altoona Center for Clinical Research","Frederick MURPHY","美国","PA","Duncansville"],["Newport Huntington Medical Group","Christine Thai","美国","CA","Huntington Beach"],["DM Clinical Research - TRA","Shaikh Ali","美国","TX","Tomball"],["Inspire Santa Fe Medical Group","Hillary Norton","美国","NM","Santa Fe"],["Innovation Medical Research Center","Yelliann Ruiz Irizarry","美国","FL","Palmetto Bay"],["TriWest Research Associates – Chula Vista","Arthur Mabaquiao","美国","CA","Chula Vista"],["Arthritis and Rheumatic Disease Specialties","Norman Gaylis","美国","FL","Aventura"],["Arthritis and Rheumatism Associates - Rockville","Evan Siegel","美国","MD","Rockville"],["GNP Research - Hollywood","Mark Jaffe","美国","FL","Cooper City"],["AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff","Alexander Hu","美国","AZ","Flagstaff"],["Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert","Daniel Kreutz","美国","AZ","Gilbert"],["Arizona Arthritis & Rheumatology Associates, P.C. - Tucson","Romy Cabacungan","美国","AZ","Tuscon"],["Kansas City Physician Partners","Tina Shah","美国","MO","Kansas City"],["Lone Star Arthritis & Rheumatology Associates, P.C.","Shariq Chudhri","美国","TX","Fort Worth"],["AARA Clinical Research - Murfreesboro Medical Clinic","Marcus Owen","美国","TN","Murfreesboro"],["AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving","Ho Bing Oei","美国","TX","Irving"],["Cohen Medical Centers","Shariar Cohen-Gadol","美国","CA","Thousand Oaks"],["Willow Rheumatology and Wellness, PLLC","Angela Crowley","美国","IL","Willowbrook"],["AARA P.C.","Amer Al-Khoudari","美国","AZ","Chandler"],["Velocity Clinical Research - West County Rheumatology, St. Louis","Sona Kamat","美国","MO","St. Louis"],["Bay Area Arthritis and Osteoporosis","Vipul Joshi","美国","FL","Brandon"],["Chicago Arthritis & Regenerative Medicine","Siddharth Tambar","美国","IL","Chicago"],["Arthritis Care of Texas","Eric Chiang","美国","TX","Corpus Christi"],["Providence Medical Foundation","Shirley Pang","美国","CA","Fullerton"],["John Hopkins University","Ana-Maria Orbai","美国","MD","Baltimore"],["Provecta Research Network LLC","Michelle Eisenberg","美国","TX","Houston"],["Rheumatology Associates","Giovanni Geslani","美国","TX","Arlington"],["AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale","Eric Peters","美国","AZ","Glendale"],["Physician Research Collaboration, LLC","Melvin Churchill","美国","NE","Lincoln"],["Oregon Health & Science University","Atul Deodhar","美国","OR","Portland"],["Perelman Center for Advanced Medicine","Alexis Ogdie","美国","PA","Philadelphia"],["Epic Medical Research","Sunny Patel","美国","TX","Red Oak"],["G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.","Louis Bessette","加拿大","QC","Quebec"],["Centre de recherche Musculo-Squelettique","Frederic Morin","加拿大","QC","Trois-Rivières"],["Toronto Western Hospital","Nigil Haroon","加拿大","ON","Toronto"],["Charite Universit？tsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol","Hildrun Haibel","德国","Berlin","Berlin"],["Rheumazentrum Ratingen Studienambulanz","Siegfried Wassenberg","德国","Nordrhein-Westfalen","Ratingen"],["HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G","Andrea Everding","德国","Hamburg","Hamburg"],["Rheumatologische Schwerpunktpraxis","Jan Brandt-Juergens","德国","Berlin","Berlin"],["Rheuma-Research Lausitz","Mario Sutowicz","德国","Brandenburg","Cottbus"],["Medicover München Ost MVZ","David Kofler","德国","Bayern","Munich"],["Zuyderland Medical Centre","Sofia Ramiro","荷兰","Limburg","Heerlen"],["Amsterdam UMC","Marleen van de Sande","荷兰","Noord-Holland","Amsterdam"],["Maasstad Ziekenhuis","Radjesh Bisoendial","荷兰","Zuid-Holland","Rotterdam"],["Zespó？ Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda","Dariusz Chudzik","波兰","Lubelskie","Lublin"],["MICS Centrum Medyczne Torun","Slawomir Jeka","波兰","Kujawsko-pomorskie","Torun"],["Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy","Rafal Wojciechowski","波兰","Kujawsko-pomorskie","Bydgoszcz"],["MICS Centrum Medyczne Warszawa","Malgorzata Socik-Pojawa","波兰","Mazowieckie","Warszawa"],["Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1","Joanna Dmowska-Chalaba","波兰","Mazowieckie","Warszawa"],["MICS Centrum Medyczne Bydgoszcz","Iwona Dankiewicz-Fares","波兰","Kujawsko-pomorskie","Bydgoszcz"],["ANKARA UNIVERSITY IBNI SINA HOSPITAL","Sebnem Ataman","土耳其","Ankara","ANKARA"],["Marmara Universitesi Pendik Egitim Arastirma Hastanesi","Mehmet Atagunduz","土耳其","Istanbul","Istanbul"],["Hacettepe Universite Hastaneleri","Levent Kilic","土耳其","Ankara","Ankara"],["Istanbul University Cerrahpasa Medical School Internal Diseases Institute","Gulen Hatemi","土耳其","Istanbul","Fatih"],["Kocaeli üniversitesi","Ayse Cefle","土耳其","Kocaeli","Kocaeli"],["NECMETTIN ERBAKAN MERAM MEDICAL FAC.","Adem Kucuk","土耳其","Konya","Konya"],["Municipal Nonprofit Enterprise","Mykola Stanislavchuk","乌克兰","Vinnytska oblast","Vinnytsa"],["Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain","Yaroslav Kleban","乌克兰","Kyiv","Kyiv"],["Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council","Anna Kulyk","乌克兰","Chernivetska oblast","Cherkasy"],["Municipal Public Non-Profit Enterprise","Mariana Vatseba","乌克兰","Ivano-Frankivska oblast","Ukraine"],["Medical Center","Nataliia Kozak","乌克兰","Kyiv","Kyiv"],["ME","Svitlana Smiyan","乌克兰","Ternopilska oblast","Ternopil"],["Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care","Halyna Hrytsenko","乌克兰","Lvivska oblast","Lviv"],["Municipal Non-Profit Enterprise","Natalya Ursol","乌克兰","Khmelnytska oblast","Khmelnytskiy"],["Medical Center of Limited Liability Company","Iryna Kurylchyk","乌克兰","Kyivska oblast","Kyiv"],["Norfolk & Norwich University Hospital NHS Foundation Trust","Karl Gaffney","大不列颠及北爱尔兰联合王国","Norfolk","Norwich"],["St Luke's Hospital","Philip Helliwell","大不列颠及北爱尔兰联合王国","Bradford","Bradford"],["Royal United Hospital Bath NHS Foundation Trust","Raj Sengupta","大不列颠及北爱尔兰联合王国","Somerset","Bath"],["Barnet Hospital","Hasan Tahir","大不列颠及北爱尔兰联合王国","Barnet","Barnet"],["Complexo Hospital de Clínicas da Universidade Federal do Paraná","Valderilio Azevedo","巴西","Parana","Curitiba"],["Centro de Pesquisas Clínicas do Hospital das Clínicas de S？o Paulo","Carla Saad","巴西","Sao Paulo","Sao Paulo"],["IBPClin - Instituto Brasil de Pesquisa Clínica","Ana Claudia Cauceglia Melazzi","巴西","Rio de Janeiro","Rio de Janeiro"],["CMIP-CENTRO MINEIRO DE PESQUISA","Rafael Fraga","巴西","Minas Gerais","Juiz de Fora"],["LMK Servi？os Médicos S/S","ALINE STRECK","巴西","Rio Grande do Sul","Porto Alegre"],["Enroll SpA","Carlos Roman","智利","Region M. de Santiago","Santiago"],["Centro de Estudios GyC","Ivan Gonzalez Abarzua","智利","Region M. de Santiago","Santiago"],["Bioreuma","Ninette Pezo","智利","Biobio","Concepcion"],["Bradfordhill","Vicente Gonzalez","智利","Region M. de Santiago","Santiago"],["Clinica Alemana Osorno","Fabian Elgueta","智利","Los Lagos","Osorno"],["Fundación Valle del Lili","ANDRES HORMAZA","哥伦比亚","Valle del Cauca","Cali."],["Clinica de la Costa S.A.S.","Jesus Godoy Martinez","哥伦比亚","Atlantico","Barranquilla."],["CIREEM SAS","Martha Mantilla","哥伦比亚","Cundinamarca","Bogota"],["Hanyang University Seoul Hospital","Tae Hwan Kim","韩国","Seoul","Seoul"],["Seoul National University Hospital","Eun Young Lee","韩国","Seoul","Seoul"],["Kyung Hee University Hosptial at Gangdong","Sang-Hoon Lee","韩国","Seoul","Seoul"],["Taipei Medical University Shuang Ho Hospital","SHENG-HONG LIN","中国台湾","新北市","新北市"],["National Taiwan University Hospital","Chiao-Feng Cheng","中国台湾","台北市","台北市"],["National Cheng Kung University Hospital","Meng-Yu Weng","中国台湾","台南市","台南市"],["Chang Gung Memorial Hospital - Linkou Branch","Ping-Han Tsai","中国台湾","桃园市","桃园市"],["Kaohsiung Veterans General Hospital","Jui-Cheng Tseng","中国台湾","高雄市","高雄市"],["Taipei Veterans General Hospital","ming-han chen","中国台湾","台北市","台北市"],["Chang Gung Memorial Hospital at Kaohsiung","Chung-Yuan Hsu","中国台湾","高雄市","高雄市"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院北京协和医院","同意","2025-09-04"]]

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: 22 ； 国际: 315 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
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：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
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；