一、题目和背景信息
| 登记号 |
CTR20254372 |
| 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 |
类风湿关节炎 |
| 试验专业题目 |
一项在类风湿关节炎受试者中评价Tulisokibart的有效性和安全性的IIb期、随机、双盲、安慰剂对照研究 |
| 试验通俗题目 |
评价Tulisokibart治疗类风湿关节炎的IIb期临床研究 |
| 试验方案编号 |
MK-7240-014 |
方案最新版本号
|
00 |
| 版本日期: |
2025-06-12 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["Merck Sharp & Dahme LLC"],["默沙东研发（中国）有限公司"],["Catalent Indiana, LLC"]] |
| 联系人姓名 |
刘馨心 |
联系人座机 |
010-58084657 |
联系人手机号 |
15011125696 |
| 联系人Email |
xinxin.liu@msd.com |
联系人邮政地址 |
北京市-北京市-朝阳区容达路21号楼 |
联系人邮编 |
100012 |
三、临床试验信息
1、试验目的
评估tulisokibart在活动性类风湿关节炎受试者中的有效性、安全性和耐受性
2、试验设计
| 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
|
3、受试者信息
| 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 |
[["筛选时临床诊断为RA，符合2010 ACR/EULAR分类标准。"],["在筛选时和随机分组时≥6个压痛关节和≥6个肿胀关节； 筛选时hsCRP值＞ULN。"],["随机分组前接受口服或注射MTX治疗已≥12周，且稳定剂量治疗已≥4周。"],["经研究者评估为bDMARD初治或 bDMARD-IR/不耐受。"],["如果在随机分组前接受以下任何允许药物的合并治疗，需要符合稳定剂量治疗持续时间： 非生物类DMARD，口服糖皮质激素或吸入性糖皮质激素，非阿片类镇痛药（全身性对乙酰氨基酚，NSAID）， 低效阿片类药物，基于肠促胰素的治疗药物。"],["性别不限，年龄为18至80周岁（含）。"]]
|
| 排除标准 |
[["患有关节炎（17岁前发病）或当前诊断为除RA以外的炎性关节疾病。"],["诊断为纤维肌痛，且在随机分组前12个月内处于活动状态，或研究者判断可能干扰有效性评估。"],["接受过器官移植并需要持续的全身免疫抑制治疗。"],["随机前5年内有癌症病史，或曾有诊断性评估提示恶性肿瘤。"],["患有活动性感染；已知感染HBV、HCV或HIV；患有结核。"],["筛选前3个月内接受过大型手术。"],["筛选前6个月内存在药物或酒精滥用。"],["既往曾暴露于tulisokibart或其他抗TL1A抗体；已知对tulisokibart或其辅料过敏、发生过超敏反应或不耐受。"],["在随机分组前≤8周内，对研究中待评估的关节进行了手术。"],["在规定的时间范围内接受过禁用药物治疗。"],["在随机分组前30天内或试验药物的5个半衰期内（以较长者为准）参加过另一项试验性临床研究。"],["筛选期实验室检查结果符合方案规定的实验室检查值排除标准。"],["存在任何状况、发现、治疗或其他情况可能混淆研究结果，或可能使受试者处于不必要风险。"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["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:安慰剂对照治疗期12周，主要扩展期44周，可选扩展期72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:安慰剂对照治疗期12周，主要扩展期44周，可选扩展期72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:安慰剂对照治疗期12周，主要扩展期44周，可选扩展期72周"]]
|
| 对照药 |
| 序号 |
名称 |
用法 |
[["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:安慰剂对照治疗期12周，直至研究揭盲为开放标签，无需再皮下注射安慰剂。"]]
|
5、终点指标
| 主要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["第12周时达到ACR20的受试者比例","第12周","有效性指标"]]
|
| 次要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["第12周时达到ACR50的受试者比例","第12周","有效性指标"],["第12周时达到ACR70的受试者比例","第12周","有效性指标"],["第12周时达到LDA（依据为DAS28-CRP≤3.2）的受试者比例","第12周","有效性指标"],["第12周时HAQ-DI较基线的变化","第12周","有效性指标"],["不良事件及因不良事件终止研究干预","整个研究期间","安全性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
张卓莉 |
学位 |
医学博士 |
职称 |
主任医师 |
| 电话 |
010-83572211 |
Email |
zhuoli.zhang@126.com |
邮政地址 |
北京市-北京市-西城区西什库大街8号 |
| 邮编 |
100034 |
单位名称 |
北京大学第一医院 |
2、各参加机构信息
| 序号 |
机构名称 |
主要研究者 |
国家 |
省（州） |
城市 |
[["北京大学第一医院","张卓莉","中国","北京市","北京市"],["临汾市中心医院","强树华","中国","山西省","临汾市"],["萍乡市人民医院","戴森华","中国","江西省","萍乡市"],["浙江省台州医院（台州恩泽医疗中心（集团））","潘绍标","中国","浙江省","台州市"],["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"],["厦门大学附属第一医院","石桂秀","中国","福建省","厦门市"],["中山大学附属第三医院","潘云峰","中国","广东省","广州市"],["新乡市中心医院","范文强","中国","河南省","新乡市"],["Advanced Rheumatology of Houston - Woodlands","Tamar Brionez","美国","TX","The Woodlands"],["Physician Research Collaboration, LLC","Melvin Churchill","美国","NE","Lincoln"],["Epic Medical Research","Sunny Patel","美国","TX","Red Oak"],["altoona center for clinical research","Alan Kivitz","美国","PA","Duncansville"],["Tekton Research, LLC.","Michael Thakor","美国","CO","Fort Collins"],["Sweet Hope Research Specialty, Inc","Carlos Sesin","美国","FL","Hialeah"],["HMD Research LLC","Sukhraj Singh","美国","FL","Orlando"],["Arizona Arthritis & Rheumatology Associates","Eric Peters","美国","AZ","Glendale"],["Arthritis & Osteoporosis Medical Center - La Palma","Gerald Ho","美国","CA","La Palma"],["Rheumatology Associates","Giovanni Geslani","美国","TX","Arlington"],["AA Medical Research Center","Ali Karrar","美国","MI","Grand Blanc"],["Rheumatology Specialty Center","Elana Eisner","美国","PA","Willow Grove"],["Kansas City Physician Partners","Tina Shah","美国","MO","Kansas City"],["AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa","Nikila Kumar","美国","AZ","Mesa"],["AARA Clinical Research - Murfreesboro Medical Clinic","Marcus Owen","美国","TN","Murfreesboro"],["Greater Chicago Specialty Physicians - Orland Park","Cory Conniff","美国","IL","Orland Park"],["Centre de recherche Musculo-Squelettique","Jean-Philippe Bergeron","加拿大","QC","Trois-Rivières"],["Mount Sinai Hospital","Bindee Kuriya","加拿大","ON","Toronto"],["Health Sciences Centre -Winnipeg","Liam O'Neil","加拿大","MB","Winnipeg"],["CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke","Javier Marrugo","加拿大","QC","Sherbrooke"],["Clinica Dermacross","LILIAN SOTO","智利","Region M. de Santiago","Santiago"],["Centro de Estudios GyC","Ivan Gonzalez Abarzua","智利","Region M. de Santiago","Santiago"],["CECIM","Maria Ines Dominguez","智利","Region M. de Santiago","Santiago"],["Pontificia Universidad Catolica de Chile-CICUC","Paula Burgos","智利","Region M. de Santiago","Santiago"],["Clinica de la Costa S.A.S.","Jesus Godoy Martinez","哥伦比亚","Atlantico","Barranquilla."],["CIREEM SAS","PATRICIA VELEZ SANCHEZ","哥伦比亚","Cundinamarca","Bogota"],["Fundación Valle del Lili","ANDRES HORMAZA","哥伦比亚","Valle del Cauca","Cali"],["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","München"],["Zespól Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda","Dariusz Chudzik","波兰","Lubelskie","Lublin"],["NZOZ BIF-MED","Hanna Mastalerz","波兰","Slaskie","Bytom"],["MICS Centrum Medyczne Torun","Slawomir Jeka","波兰","Kujawsko-pomorskie","Torun"],["Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej","Rafal Wojciechowski","波兰","Kujawsko-pomorskie","Bydgoszcz"],["MICS Centrum Medyczne Warszawa","Malgorzata Socik-Pojawa","波兰","Mazowieckie","Warszawa"],["Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji","Joanna Dmowska-Chalaba","波兰","Mazowieckie","Warszawa"],["MICS Centrum Medyczne Bydgoszcz","KATARZYNA KOLOSSA","波兰","Kujawsko-pomorskie","Bydgoszcz"],["Hospital Universitari Parc Tauli","María Garcia Manrique de Lara","西班牙","Barcelona","Sabadell"],["Hospital Universitari Vall d'Hebron","Maria Lopez Lasanta","西班牙","Barcelona","Barcelona"],["Hospital Clinico Universitario de Santiago","Eva Perez Pampin","西班牙","La Coruna","Santiago de Compostela"],["Hospital Universitario Marqués de Valdecilla","Ricardo Blanco Alonso","西班牙","Cantabria","Santander"],["Barnet Hospital","Hasan Tahir","大不列颠及北爱尔兰联合王国","United Kingdom","London"],["The Princess Alexandra Hospital NHS Trust","KHALID AHMED","大不列颠及北爱尔兰联合王国","England","Harlow"],["Chapel Allerton Hospital","Paul Emery","大不列颠及北爱尔兰联合王国","Leeds","Leeds"],["Hanyang University Seoul Hospital","Chan-Bum Choi","韩国","Seoul","Seoul"],["Chungnam national university hospital","Seung Cheol Shim","韩国","Taejon-Kwangyokshi","Daejeon"],["Soon Chun Hyang University Cheonan Hospital","Sung Hae Chang","韩国","Chungnam","Cheonan-si"],["Kai Clinic","Mutsuaki Kai","日本","Miyazaki","Miyazaki"],["Hirose Clinic","Wataru Hirose","日本","Saitama","Tokorozawa"],["Sasebo Chuo Hospital","Yukitaka Ueki","日本","Nagasaki","Sasebo"],["University of Yamanashi Hospital","Daiki Nakagomi","日本","Yamanashi","Chuo"],["Nagaoka Red Cross Hospital","Takako Saeki","日本","Niigata","Nagaoka"],["Toshin Yoshida Internal Medicine Rheumatology","Tomohiko Yoshida","日本","Nagano","Hanishina-gun"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["北京大学第一医院生物医学研究伦理委员会","同意","2025-09-03"],["北京大学第一医院生物医学研究伦理委员会","同意","2025-10-16"]]
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: 18 ；
国际: 182 ； |
| 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； |
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：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； |
