北京Nemolizumab注射液II期临床试验-Nemolizumab治疗成人系统性硬化症的研究

登记号	CTR20263715	试验状态	进行中
申请人联系人	李品	首次公示信息日期	2026-09-28
申请人名称	Galderma SA/ 科医国际贸易（上海）有限公司/ Vetter Pharma-Fertigung GmbH & Co. KG

登记号	CTR20263715
相关登记号	暂无
药物名称	Nemolizumab注射液
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	系统性硬化症
试验专业题目	一项 Nemolizumab 治疗系统性硬化症成人患者的 II 期、多中心、随机、双盲、安慰剂对照、剂量范围研究，包括 52 周主治疗期和 156 周扩展治疗期
试验通俗题目	Nemolizumab治疗成人系统性硬化症的研究
试验方案编号	SPR207796	方案最新版本号	6.0
版本日期:	2025-12-04	方案是否为联合用药	否

申请人名称	[["Galderma SA"],["科医国际贸易（上海）有限公司"],["Vetter Pharma-Fertigung GmbH & Co. KG"]]
联系人姓名	李品	联系人座机	021-23159790	联系人手机号
联系人Email	pin.li@galderma.com	联系人邮政地址	上海市-上海市-上海市黄浦区湖滨路168号无限极大厦7楼	联系人邮编	200021

在系统性硬化症（SSc）成人患者中，经过 52周治疗期后，评估nemolizumab 与安慰剂相比对皮肤增厚的有效性，并为该目标人群选择最佳剂量

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 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["在签署知情同意书时，受试者必须年满18岁或以上，或符合入组国家的法定成人年龄要求（如果超过18 岁）"],["根据 2013 年美国风湿病学会[ACR]/欧洲风湿病学会[EULAR]标准定义的 SSc分类"],["病程： na. 距筛选≤5 年的弥漫性皮肤系统性硬化症（DcSSc）受试者 nb. 距筛选≤2 年的局限性皮肤系统性硬化症（LcSSc）受试者 n病程定义为自首次出现 SSc 非雷诺现象临床表现的时间"],["改良 Rodnan 皮肤评分： na. 筛选和基线时改良 Rodnan 皮肤评分（mRSS）≥12且<30的DcSSc 受试者 nb. 筛选和基线时 mRSS≥8 的 LcSSc 受试者。排除筛选时抗着丝点阳性的LcSSc 受试者"],["允许受试者在基线前接受以下稳定的背景治疗至少3个月，包括以下任何组合： na. 尼达尼布（≤150 mg，每日两次）和/或 nb. 以下其中一项： n1) 甲氨蝶呤（MTX）（≤25 mg 每周一次）或 n2) 麦考酚酯 （ MMF ）、麦考酚钠（MPS）或麦考酚酸（MPA）（MMF≤3000mg每日，MPS或MPA≤2160mg每日） n注：MTX不应与MMF/MPS/MPA联合使用"],["有活动性或进展性疾病证据的受试者"],["男性（其女性伴侣有生育能力）和有生育能力的女性，需要在研究期间和接受末次研究治疗后至少 12 周内，在符合其偏好和日常生活方式的情况下，使用有效的避孕方法或承诺真正禁欲"],["不具备生育能力的女性受试者必须符合以下标准之一：na. 无任何其他医学原因，在筛选前 1 年内无月经出血。对于 60 岁以下的女性，应通过促卵泡激素（FSH）水平≥40 IU/L 确认绝经后状态；对于60岁以上的女性，无需 FSH 确认 nb. 筛选前至少3个月有子宫切除术、双侧输卵管切除术或双侧卵巢切除术的记录"],["签署了知情同意书"],["受试者愿意并能够遵守临床研究方案的所有时间承诺和程序要求，包括使用电子 eCOA/ePRO 类设备"]]
排除标准	[["LcSSc受试者筛选时抗着丝点抗体阳性"],["病程>18个月且抗 RNA 聚合酶III抗体阳性的受试者"],["肌酐清除率<30 mL/min（采用Cockcroft-Gault公式计算）"],["血清学结果阳性（乙型肝炎表面抗原[HBsAg]或乙型肝炎核心抗体[HbcAb]、丙型肝炎[HCV]抗体阳性且 HCV RNA 阳性的HCV 抗体确证试验阳性，或人类免疫缺陷病毒[HIV]抗体阳性）"],["筛选时 FVC<预计正常值的 50%（即 ppFVC<50%），DLCO<Hb校正的预计正常值的 40%（即 ppDLCOc<40%）"],["目前已列入肺移植名单和/或预计在未来12 个月内被列入肺移植名单"],["伴有需要治疗的临床显著心律失常的心血管疾病、充血性心力衰竭（纽约心脏病协会 III-IV 级功能能力）、不稳定型心绞痛、未受控制的高血压、肺源性心脏病或有症状的心包积液"],["筛选前 6 个月内有心肌梗死病史"],["需要治疗的肺动脉高压，WHO 功能分级为三级或更高（根据 WHO 2009 定义）"],["研究者认为出现重度吸收不良或需要肠外营养的临床体征"],["筛选前 6 个月内有硬皮病肾危象（SRC）病史"],["有基础慢性肝病的受试者（Child Pugh 分级为 A、B、C 级肝功能损害）"],["筛选或基线时体重<30.0千克（kg）"],["妊娠或哺乳期女性，或研究期间计划妊娠或哺乳的女性，或不愿意在研究期间采取适当避孕措施的女性"],["既往接受过 nemolizumab 治疗"],["受试者主要诊断为SSc以外的风湿性自身免疫性疾病，包括但不限于类风湿性关节炎、系统性红斑狼疮、多发性肌炎、皮肌炎、系统性血管炎、舍格林综合征、抗合成酶综合征或混合性 CTD，诊断需由研究者与医学监查员协商确定"],["系统性硬化症样疾病，包括但不限于局限性硬皮病（硬斑病）、嗜酸粒细胞增多性筋膜炎、硬皮病样移植物抗宿主病、纤维黏液性疾病（硬化病、硬化性黏液水肿）、与环境化学和药物暴露相关的硬皮病样疾病（例如，毒性菜籽油、氯乙烯、博来霉素、含钆造影剂[肾源性系统性纤维化]或代谢性疾病所致）"],["对免疫球蛋白产品（血浆来源或重组，例如单克隆抗体）或任何研究药物辅料有超敏反应史（包括过敏性休克）"],["已知在筛选前 4 周内需要住院、静脉注射（IV）抗生素或抗病毒药物治疗，或在筛选前 2 周内需要口服抗生素的活动性细菌、病毒、真菌或任何重大感染发作。一旦感染消退，可对受试者进行重新筛选"],["原发性免疫缺陷病史"],["骨髓移植史。嵌合抗原受体（CAR）T 细胞疗法或任何其他基因工程细胞治疗"],["在过去 5 年内有淋巴细胞增生性疾病史或任何器官系统的恶性肿瘤史，但不包括 (1) 已治疗且在基线访视前 12 周内无复发证据的基底细胞癌、原位鳞状细胞癌（鲍温病）或宫颈原位癌，或 (2) 已治疗的光化性角化症"],["有酒精或药物滥用依赖史，或研究者认为受试者不能可靠遵循指导并完成研究的任何状况"],["研究者认为受试者患有可能对受试者造成不当风险、妨碍研究完成或对研究测量的有效性或可解释性产生不利影响，或干扰研究评估或妨碍受试者完成研究能力的任何医学疾病，包括具有临床意义的肺部异常或心理状况，或具有临床意义的实验室检查异常"],["受试者在筛选前未遵守所选治疗的限制，或预期在研究期间不遵守方案所要求的限制用药"],["已知诊断为除ILD以外的具有临床意义的呼吸系统疾病，包括重度慢性阻塞性肺疾病、重度哮喘、近期（3 个月内）重度呼吸道感染或复发性呼吸道感染病史、吸烟和研究者认为可能干扰研究或对受试者构成风险的任何其他呼吸系统疾病"]]

试验药	[["中文通用名:Nemolizumab注射液 英文通用名:Nemolizumabinjection 商品名称:NA","剂型:注射剂 规格:30mg/0.49mlDCC-AI 用法用量:皮下注射给药，30/60mg（基于体重）每4周1次给药 用药时程:0-208周"],["中文通用名:Nemolizumab注射液 英文通用名:Nemolizumabinjection 商品名称:NA","剂型:注射剂 规格:30mg/0.49mlDCC-AI 用法用量:皮下注射给药，90/120mg（基于体重）每4周1次给药 用药时程:0-208周"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:注射剂 规格:0.49mlDCC-AI 用法用量:每4周1次皮下注射给药 用药时程:0-52周"]] 序号 名称 用法

主要终点指标及评价时间

[["改良 Rodnan 皮肤评分（mRSS；使用 0-3 分量表在 17 个体表区域评估皮肤增厚）较基线（BL）的变化","基线，第52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

[["用力肺活量（FVC；mL）较BL的变化","基线，第52周","有效性指标"],["根据修订版系统性硬化症复合应答指数（rCRISS）确定的治疗有效者比例","第52周","有效性指标"],["mRSS 较基线期的变化","第 8、12、24、28、36、44 周","有效性指标"],["mRSS 较基线期的百分比变化","基线，第52周","有效性指标"],["治疗期间 AE（TEAE）、治疗期间严重 AE（SAE）、治疗期间特别关注的 AE（AESI）、重大 SSc 相关TEAE、导致研究药物停药的 TEAE 和导致研究中止的 TEAE","整个研究期间","安全性指标"],["异常生命体征的发生率","至 52 周、至160周（仅血压）","安全性指标"],["异常实验室参数的发生率","至 52 周、至160周","安全性指标"],["异常心电图（ECG）结果的发生率","至 52 周","安全性指标"],["体重异常变化的发生率","至 52 周、至160周","安全性指标"],["FVC 占预计值百分比（ppFVC）较基线期的变化","基线，第52周","有效性指标"],["健康评估问卷 残疾指数（HAQ-DI）较基线期的百分比变化；","基线，第52周","有效性指标"],["患者整体评估（PGA）评分较基线期的百分比变化","基线，第52周","有效性指标"],["临床医生整体评估（CGA）评分较基线期的百分比变化","基线，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	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-北京
	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","曾小峰","中国","北京市","北京市"],["北京大学第三医院（北京大学第三临床医学院）","穆荣","中国","北京市","北京市"],["昆明医科大学第一附属医院（云南省皮肤病医院）","徐健","中国","云南省","昆明市"],["中山大学附属第三医院（中山大学肝脏病医院）","潘云峰","中国","广东省","广州市"],["中山大学附属第八医院（深圳福田）","张晓","中国","广东省","深圳市"],["四川大学华西医院（四川省国际医院）","崔贝贝","中国","四川省","成都市"],["浙江大学医学院附属第二医院、浙江省第二医院","孙闻嘉","中国","浙江省","杭州市"],["上海交通大学医学院附属仁济医院","李挺","中国","上海市","上海市"],["中国医科大学附属第一医院","杨娉婷","中国","辽宁省","沈阳市"],["吉林大学第一医院","姜振宇","中国","吉林省","长春市"],["Instituto CER S.A.","Cristian Benitez","阿根廷","Buenos Aires","Quilmes"],["IBAMEDICA","Nadia Raquel Benzaquen","阿根廷","Santa Fe","Santa Fe"],["Centro de Investigaciones Médicas Tucumán - PPDS","Horacio Berman","阿根廷","Tucumán","San Miguel de Tucumán"],["Consultorios Médicos Dr. Doreski - PPDS","Abel Bordón","阿根廷","Buenos Aires","Ciudad Autónoma"],["Sanatorio Allende S.A.-Hipolito Yrigoyen 384","Mariano Gottero","阿根廷","Córdoba","Córdoba"],["Framingham Centro Médico","Amelia Beatriz Granel","阿根廷","Buenos Aires","La Plata"],["Organización Médica de Investigación","María Lopez Meiller","阿根廷","Buenos Aires","Ciudad Autónoma"],["Instituto Médico Río Cuarto","Hernan Maldonado Ficco","阿根廷","Córdoba","Río Cuarto"],["Aprillus Asistencia e Investigacion - Terrada 89","Pablo Mannucci Walter","阿根廷","Buenos Aires","Ciudad Autónoma"],["Sanatorio Parque S.A.-Boulevard Nicasio Orono 860","Bernardo Pons-Estel","阿根廷","Santa Fe","Rosario"],["Centro Médico Dr. Javier Tartaglione","Oscar Rillo","阿根廷","Buenos Aires","Ciudad Autónoma"],["Consultora Integral de Salud Centro Médico Privado","Veronica Saurit","阿根廷","Córdoba","Córdoba"],["Centro de Investigaciones Reumatológicas","Maria Silvia Yacuzzi","阿根廷","Tucumán","San Miguel"],["University Multiprofile Hospital for Active Treatment Kaspela","Anastas Batalov","保加利亚","Plovdiv Province","Plovdiv"],["University Multi-Profile Hospital for Active Treatment St. Ivan Rilski EAD - ul. Urvich 13","Mariana Ivanova Goycheva","保加利亚","Sofia City Province (Sofia-Grad)","Sofia"],["University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard","Krasimir Kraev","保加利亚","Plovdiv Province","Plovdiv"],["University Multi-Profile Hospital for Active Treatment St. Ivan Rilski EAD - ul. Urvich 13","Rasho Rashkov","保加利亚","Sofia City Province (Sofia-Grad)","Sofia"],["University Multiprofile Hospital for Active Treatment Pulmed OOD","Lyubomir Sapundzhiev","保加利亚","Plovdiv Province","Plovdiv"],["Centro de especialidades médicas Vanguardia","Carlos Alberto Baumert Llanos","智利","Cautín","Temuco"],["BIOCINETIC Ltda","Maria Ines Dominguez","智利","Santiago","Santiago"],["Centro de Investigacion de Enfermedades Respiratorias e inmunologicas","Renato Jimenez Calabresse","智利","Valparaíso","Vina del Mar"],["Centro de Estudios Clinicos Victoria Limitada (Cevic)-Centro Victoria","Carlos Martinez Herrera","智利","Malleco","Victoria"],["Enroll SpA - Dr. Manuel Barros Borgono - PPDS","Carlos Roman Zamorano","智利","Santiago","Providencia"],["Clinica Universidad De la Sabana","Hermencia Aponte Murcia","哥伦比亚","Cundinamarca Department","Chía"],["Fundacion Santa Fe de Bogotá","Wilson Bautista Molano","哥伦比亚","Bogotá, D.C.","Bogotá"],["Hospital Universitario San Ignacio","Maria Diaz Jimenez","哥伦比亚","Bogotá, D.C.","Bogotá"],["Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin","Miguel Antonio Mesa Navas","哥伦比亚","Antioquia Department","Medellín"],["Hospital Pablo Tobon Uribe","Neil Pertuz Charris","哥伦比亚","Antioquia Department","Medellín"],["Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - CIREEM S.A.S","Patricia Velez Sanchez","哥伦比亚","Bogotá, D.C.","Bogotá"],["Polyclinic Bonifarm","Marinko Bilusic","克罗地亚","City of Zagreb","Zagreb"],["Poliklinika Solmed","Fanika Mrsic","克罗地亚","City of Zagreb","Zagreb"],["Special Hospital Medico","Marija Rogoznica Pavlovic","克罗地亚","Primorje-Gorski Kotar County","Rijeka"],["Centre Hospitalier Le Mans","Nathalie Beneton","法国","Sarthe","Le Mans"],["Hopital d'Instruction des Armées de Sainte Anne","Thierry Boye","法国","Var","Toulon"],["CHU de Saint-Etienne - Hopital Nord","Martin Killian","法国","Loire","Saint-Priest-en-Jarez"],["CHU de Lille - Hopital Claude Huriez","David Launay","法国","Nord","Lille"],["CHU d'Angers","Christian Lavigne","法国","Maine-et-Loire","Angers"],["CHU de Rennes - Hopital Pontchaillou","Alain Lescoat","法国","Ille-et-Vilaine","Rennes"],["CHU de Nice-Hopital L'Archet","Nihal Martis","法国","Alpes-Maritimes","Nice"],["CHU de Toulouse- Hopital de Rangueil","Gregory Pugnet","法国","Haute-Garonne","Toulouse"],["CHRU de Tours - Hopital Bretonneau","Benjamin Thoreau","法国","Indre-et-Loire","Tours"],["EUROMEDICA General Clinic of Thessaloniki","Nikolaos Kougkas","希腊","Thessaloniki Regional Unit","Thessaloniki"],["Laiko General Hospital of Athens","Clio P Mavragani","希腊","Attica Region","Athens"],["PAGNI-University General Hospital of Heraklion","Prodromos Sidiropoulos","希腊","Heraklion Regional Unit","Heraklion"],["AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova","Emanuele Cocchiara","意大利","Reggio Emilia Province","Reggio Emilia"],["Fondazione Policlinico Universitario A Gemelli - Rome - PPDS","Maria Antonietta D'Agostino","意大利","ome Metropolitan City","Roma"],["ASST Ovest Milanese - Ospedale Nuovo di Legnano","Antonino Mazzone","意大利","Metropolitan City of Milan","Legnano"],["Seoul National University Hospital","Eun Bong Lee","韩国","Seoul","Seoul"],["Hanyang University Seoul Hospital","Jae-Bum Jun","韩国","Jeollabuk-do","Seoul"],["Gangnam Severance Hospital, Yonsei University Health System","Min-Chan Park","韩国","Seoul","Seoul"],["Ajou University Hospital","Chang-Hee Suh","韩国","Gyeonggi-do","Suwon-si"],["University Malaya Medical Centre","Raja Jasmin Begum Raja Mohamed","马来西亚","Kuala Lumpur","Kuala Lumpur"],["Hospital Umum Sarawak","Cheng Lay Teh","马来西亚","Sarawak","Kuching"],["Centro Integral Reumatologia SA de CV","Hilario Avila Armengol","墨西哥","Jalisco","Americana"],["Centro Peninsular de Investigacion S.C.P","Francisco Avila Zapata","墨西哥","Yucatán","Merida"],["CENTRO DE INVESTIGACION FARMACOLOGICA DEL BAJIO SC","Leonel Daza Benitez","墨西哥","Guanajuato","Leon"],["Centro de Estudios de Investigacion Basica Y Clinica SC","Ignacio Garcia-Valladares","墨西哥","Jalisco","Guadalajara"],["Centro de Investigación y Tratamiento Reumatológico S.C","Fedra Irazoque-Palazuelos","墨西哥","Distrito Federal","Mexico City"],["FAICIC","Monica Macias Palacios","墨西哥","Veracruz","Fracc Ricardo Flores Magón"],["Clinstile, S.A. de C.V.","Juan Manuel Martinez Noriega","墨西哥","Distrito Federal","Mexico City"],["Centro de Investigacion Clinica Acelerada, S.C.","Katia Ramirez Santillan","墨西哥","Ciudad de México","Ciudad de México"],["Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","Tatiana Rodriguez-Reyna","墨西哥","Ciudad de México","Tlalpan"],["PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS","Gabriela Sierra-Jimenez","墨西哥","Jalisco","Guadalajara"],["Kohler and Milstein Research S.A. de C.V","Jesus Abraham Simon Campos","墨西哥","Yucatán","Mérida"],["Mediadvance Clinical S.A.P.I. de C.V.","Adelfia Urenda-Quezada","墨西哥","Chihuahua","Chihuahua"],["Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.","Agnieszka Bielewicz-Zielinska","波兰","Pomeranian","Malbork"],["Centrum Medyczne Plejady Magdalena Celinska – Lowenhoff, Michal Zolnowski Spolka komandytowa","Magdalena Celinska-Lowenhoff","波兰","Lesser Poland","Kraków"],["Centrum Medyczne Linden","Weronika Kleczynska-Szpakiewicz","波兰","Lesser Poland","Kraków"],["Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Curie-Sklodowskiej 24a","Otylia Kowal-Bielecka","波兰","Podlaskie","Bialystok"],["Twoja Przychodnia NCM","Malgorzata Miakisz","波兰","Lubusz","Nowa Sól"],["Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS","Katarzyna Romanowska-Prochnicka","波兰","Masovian","Warszawa"],["Malopolskie Centrum Kliniczne","Ewa Zimmer-Satora","波兰","Lesser Poland","Kraków"],["Military Medical Academy","Jelena Ceranic","塞尔维亚","Belgrade","Belgrade"],["Institute of Rheumatology - PPDS","Ivan Jeremic","塞尔维亚","Belgrade","Belgrade"],["Institute of Rheumatology - PPDS","Aleksandar Radivcev","塞尔维亚","Belgrade","Belgrade"],["Institute for Treatment and Rehabilitation Niska Banja","Bojana Stamenkovic","塞尔维亚","Nisava","Niska Banja"],["University Clinical Center Kragujevac","Aleksandra Tomic-Lucic","塞尔维亚","Sumadija","Kragujevac"],["Institute of Rheumatology - PPDS","Tatjana Zivanovic Radnic","塞尔维亚","Belgrade","Belgrade"],["Hospital Universitario Doctor Peset","Juan Jose Alegre","西班牙","Valencia","Valencia"],["Hospital Universitario A Coruna","Mercedes Freire Gonzalez","西班牙","a Coruna","a Coruna"],["Corporacio Sanitaria Parc Tauli","Silvia Garcia Cirera","西班牙","Barcelona","Sabadell"],["Hospital Quironsalud Malaga","Noemi Garrido Punal","西班牙","Málaga","Malaga"],["Hospital Universitario Vall d'Hebron - PPDS","Alfredo Guillen del Castillo","西班牙","Barcelona","Barcelona"],["C.H. Regional Reina Sofia","Rafaela Ortega Castro","西班牙","Córdoba","Cordoba"],["Hospital Universitario de Basurto","Esther Ruiz Lucea","西班牙","Biscay","Bilbao"],["Universitatsspital Zürich","Muriel Elhai","瑞士","Zürich","Zürich"],["Kantonsspital St. Gallen","Frauke Foerger","瑞士","St. Gallen","St. Gallen"],["Phramongkutklao Hospital","Sumapa Chaiamnuay","泰国","Bangkok Metropolis","Thung Phaya Thai"],["Prince of Songkhla University","Porntip Intapiboon","泰国","Songkhla","Hat Yai"],["Ramathibodi Hospital","Pintip Ngamjanyaporn","泰国","Bangkok Metropolis","Thung Phaya Thai"],["Luton and Dunstable University Hospital - PPDS","Muhammad Nisar","英国","Bedfordshire","Luton"],["Royal Free Hospital - PPDS","Voon Ong","英国","Great London","London"],["Northwestern Medical Group","Bradford Charles Bemiss","美国","Illinois","Chicago"],["Rheumatology Associates - Arlington","Giovanni Geslani","美国","Texas","Arlington"],["Yale Center for Clinical Investigations","Monique Hinchcliff","美国","Connecticut","New Haven"],["UT Physicians Rheumatology","Maureen Mayes","美国","Texas","Houston"],["Thomas Jefferson University","Fabian A Mendoza-Ballesteros","美国","Pennsylvania","Philadelphia"],["University of Michigan Hospital - 1500 E Medical Center Dr","Mio Nakamura","美国","Michigan","Ann Arbor"],["Life Clinical Trials","Jigar Shah","美国","Florida","Margate"],["Hospital For Special Surgery","Robert Spiera","美国","New York","New York"],["Southeastern Research Center","Hassan Yousaf","美国","North Carolina","Winston Salem"],["Tam Anh Hospital - PPDS","Lam Thi Hoang","越南","Ho Chi Minh","Ho Chi Minh"],["Vinmec Times City International Hospital - PPDS","Van Dinh Nguyen","越南","Hanoi","Ha Noi"],["University of Medicine Center, Ho Chi Minh City","Thuy Hong Tran","越南","Ho Chi Minh","Ho Chi Minh"]]

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药物临床试验伦理委员会","同意","2026-07-30"]]

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: 16 ； 国际: 162 ；
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；