北京Depemokimab注射液IV期临床试验-在有风险的成人和青少年2型哮喘患者中比较Depemokimab与安慰剂的有效性和安全性的IIIb/IV期研究（MODIFY）。

登记号	CTR20263030	试验状态	进行中
申请人联系人	李雪菲	首次公示信息日期	2026-08-04
申请人名称	GlaxoSmithKline Research & Development Limited/ 葛兰素史克（中国）投资有限公司/ Glaxo Operations UK Limited trading as Glaxo Wellcome Operations

登记号	CTR20263030
相关登记号	暂无
药物名称	Depemokimab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	成人和青少年2型哮喘
试验专业题目	MODIFY研究：一项评估Depemokimab早期干预有风险的成人和青少年2型哮喘患者对急性发作率、临床治愈、肺功能下降和安全性的影响的为期最长156周、IIIb/IV期、随机、双盲、安慰剂对照、多中心研究。
试验通俗题目	在有风险的成人和青少年2型哮喘患者中比较Depemokimab与安慰剂的有效性和安全性的IIIb/IV期研究（MODIFY）。
试验方案编号	222926	方案最新版本号	修正案I
版本日期:	2025-12-19	方案是否为联合用药	否

申请人名称	[["GlaxoSmithKline Research & Development Limited"],["葛兰素史克（中国）投资有限公司"],["Glaxo Operations UK Limited trading as Glaxo Wellcome Operations"]]
联系人姓名	李雪菲	联系人座机	020-28339666	联系人手机号
联系人Email	zhixian.z.li@gsk.com	联系人邮政地址	广东省-广州市-越秀区中山六路218－222号捷泰广场15楼	联系人邮编	510180

主要目的：评估与安慰剂相比，每26周给药一次Depemokimab 100 mg（SC）的附加治疗，在正在接受ICS/LABA哮喘治疗但仍存在急性发作风险的T2炎症型哮喘受试者中的有效性 次要目的：评估与安慰剂相比，每26周给药一次Depemokimab 100 mg（SC），在正在接受ICS/LABA哮喘治疗但仍存在急性发作风险的T2炎症型哮喘受试者中符合临床治愈定义的受试者比例；评估与安慰剂相比，每26周给药一次Depemokimab 100 mg（SC）对基线时哮喘未受控制的受试者亚组QoL的影响；评估与安慰剂相比，每26周给药一次Depemokimab 100 mg（SC）对基线时哮喘未受控制的受试者亚组哮喘控制的影响；探讨与安慰剂相比，每26周给药一次Depemokimab 100 mg（SC）对正在接受ICS/LABA哮喘治疗但仍存在急性发作风险的T2炎症型哮喘受试者肺功能的影响。

试验分类	安全性和有效性	试验分期	IV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	12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	[["年龄：在签署知情同意书/未成年人知情同意书时年龄≥12岁的成人和青少年。对于当地法规或研究药物的监管状态仅允许入组成人的国家/地区，招募的受试者须≥18岁。"],["哮喘诊断：受试者必须具有符合美国国家心肺血液研究所、NICE或GINA指南的医生诊断记录显示患有哮喘≥2年。"],["急性发作史筛选前3年内有至少2次既往确认的急性发作，并且筛选访视1前一年内至少有1次急性发作。n --尽管已使用低至中等剂量ICS/LABA，但仍需要全身性CS（IM、IV或口服）治疗急性发作，持续至少3天。"],["哮喘SoC：有明确记录表明需要接受低至中等剂量ICS/LABA治疗（筛选访视前12个月内，[GINA, 2025]，参见第10.10节（附录10））。治疗应在筛选前保持稳定达3个月。如果受试者定期接受维持和缓解治疗/单一维持和缓解治疗，则每日总剂量应纳入低剂量或中等剂量ICS的评估中。n --本研究将限制入组患者中接受低剂量ICS/LABA的患者比例，最多40%。"],["性别和避孕/屏障措施要求 男性或符合条件的女性受试者：n --男性受试者：对于有女性伴侣的男性受试者，不要求进行避孕。n --女性受试者：如果女性受试者未妊娠或未哺乳，并且符合下列条件之一，则有资格参加研究：n - 受试者为PONCBPn或n - 为POCBP，并从研究治疗首次给药前至少14天至研究治疗末次给药后至少35周期间持续使用高效避孕方法（失败率<1%，具体实施要求参见第10.4.2节）。n --POCBP必须在筛选访视1、退出访视11或退出研究访视时进行高灵敏度血清妊娠试验且结果为阴性，并在研究治疗首次给药前24小时内进行高灵敏度尿妊娠试验且结果为阴性。n --女性受试者采取的避孕措施应符合当地有关临床研究受试者避孕方法的法规要求。n --研究者应评估避孕方法失败的可能性（例如未依从，或在接近研究治疗首次给药时才开始使用）。n --研究者负责审查受试者的病史、月经史和近期性行为情况，以降低纳入未被察觉的早期妊娠女性的风险。n 注：如果研究开始后受试者的生育能力发生变化（例如尚未经历月经初潮的女性受试者出现初潮），或妊娠风险发生改变（例如原本无异性性行为的女性受试者开始此类活动），则受试者必须与研究者进行商谈，由研究者判断是否需要立即开始采用高效避孕方法。如果对生殖状态存疑，应考虑进行额外评估。"],["知情同意：能够签署知情同意书/未成年人知情同意书，包括同意遵守ICF和本方案中列出的要求和限制。"],["在导入期结束时，研究受试者必须满足以下所有随机化入选/排除标准，才能随机分配至接受研究治疗。nRINC#1 – T2型哮喘：具有T2高表达哮喘且存在急性发作风险，定义为满足以下任一条件：n--筛选时外周血EOS计数升高≥500个细胞/mL，或筛选访视前3个月内出现升高≥500个细胞/mL。n或n--筛选时外周血EOS计数升高≥300个细胞/mL，或筛选访视前3个月内出现升高≥300个细胞/mLn且n--筛选时FeNo≥35 ppb。n或n--记录证实当前存在CRSwNP。"]]
排除标准	[["在访视1前一年内出现过≥3次急性发作的受试者。"],["使用OCS维持治疗或高剂量ICS/LABA治疗哮喘的受试者。"],["哮喘病程>20年的受试者。"],["除哮喘外，已知存在具有临床意义的基础肺部疾病。这包括（但不限于）当前感染、支气管扩张、肺纤维化、支气管肺曲霉病或肺癌病史。排除当前诊断为肺气肿或慢性支气管炎（除哮喘外的COPD）的受试者。"],["有其他可能导致EOS升高疾病的受试者，例如高嗜酸性粒细胞综合征，包括但不限于嗜酸性肉芽肿性多血管炎（之前称为Churg-Strauss综合征）或嗜酸细胞性食管炎。"],["在筛选前4周内出现急性发作的受试者。n注：如果受试者出现急性发作情况，可在症状缓解后重新安排筛选访视，此时需确保距离治疗急性发作的药物末次给药已经过至少4周。"],["在筛选前6个月内已知存在基础寄生虫侵染的受试者，除非已接受治疗且有证据表明其已缓解。"],["已知存在免疫缺陷（例如，人类免疫缺陷病毒），但因哮喘治疗使用的CS所导致的情况除外。"],["当前存在恶性肿瘤或筛选前缓解期<12个月的既往癌症史。n注：不排除接受了根治性切除术的局部皮肤癌受试者。"],["已知存在具有临床意义的基础心脏、内分泌、自身免疫、代谢、神经系统、精神、肾脏、胃肠、肝脏、血液或其他系统异常，且经标准治疗后仍未受控制的受试者。"],["当前诊断为血管炎的受试者。n注：将对筛选时临床高度怀疑为血管炎的受试者进行评估，入组前必须排除当前患有血管炎的受试者。"],["接受过任何已批准或试验性生物制剂mAb治疗的受试者。"],["在研究治疗首次给药前2年内有酗酒或物质滥用史（或疑似病史）。"],["目前吸烟者或既往吸烟者（吸烟史320包年（包年数=[每天吸烟支数/20]×吸烟年数））和电子烟使用者。n注：既往吸烟者定义为在筛选前至少6个月已戒烟的受试者。"],["对mAb或生物制剂或任何Depemokimab辅料（参见表3）过敏/不耐受的受试者。"],["妊娠期或哺乳期的受试者。n注：如果受试者计划在研究期间妊娠，则不得入组。"],["有证据表明对控制药物不依从和/或无法遵从医生建议的受试者。"],["有证据表明，根据研究者判断，筛选（访视0）时血液学、生化或尿分析筛选结果异常且具有临床意义。"],["ALT>2xULN。"],["总胆红素>1.5×ULN；对于患有Gilbert综合征的受试者：如果直接胆红素≤1.5×ULN，总胆红素>1.5×ULN也可入组。"],["肝硬化或经研究者评估认为当前存在不稳定的肝脏或胆道疾病，定义为存在腹水、脑病、凝血障碍、血白蛋白过少、食管或胃静脉曲张、持续性黄疸。n注：患有稳定的非肝硬化性慢性肝病（包括Gilbert综合征、无症状胆结石、稳定的慢性HBV [已排除HDV]或丙型肝炎），若受试者同时符合其他入选标准，则此类情况可接受。"],["ECG评估：QTcF ≥450 ms，或束支阻滞受试者QTcF ≥480 ms（基于筛选访视的12导联ECG中心判读或访视1的12导联ECG机器判读）。"],["根据研究者的评估，若筛选访视时12导联ECG经中心判读发现异常结果且具有临床意义，可能影响受试者参加研究，则该受试者将被排除。nn在导入期结束时，如果受试者符合以下任一标准，将不予随机化：n1.tREXC#1 - ECG评估：QTcF ≥450 ms，或束支阻滞受试者QTcF ≥480 ms（基于筛选访视的12导联ECG中心判读或访视1的12导联ECG机器判读）。n2.tREXC#2 - ALT >2×ULN。n3.tREXC#3 - 总胆红素>1.5×ULN；对于患有Gilbert综合征的受试者，如果直接胆红素≤1.5×ULN，总胆红素>1.5×ULN也可入组。n4.tREXC#4 - 哮喘不稳定：如果受试者在随机化前7天内出现具有临床意义的哮喘急性发作，应推迟其随机化访视，直至研究者确认受试者哮喘病情恢复稳定。n5.tREXC#5 - 哮喘维持治疗：在导入期，任何基线ICS的剂量或方案发生变化和/或加用控制药物（治疗急性发作除外）。"]]

试验药	[["中文通用名:德莫奇单抗 英文通用名:depemokimab 商品名称:易适来®","剂型:注射剂 规格:100mg（1ml）/支（单剂量预充式安全注射器） 用法用量:每26周一次给予100mg 用药时程:100mgSC,每26周给药一次，持续52周"]] 序号 名称 用法
对照药	[["中文通用名:氯化钠溶液 英文通用名:sodiumchloridesolution 商品名称:NA","剂型:注射液 规格:0.9% 用法用量:每26周一次给予100mg 用药时程:100mgSC,每26周给药一次，持续52周"]] 序号 名称 用法

主要终点指标及评价时间	[["GSK3511294/Depemokimab+SoC与安慰剂+SoC的急性发作率比值","治疗期间","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	[["2年时达到临床治愈的比值比","第2年","有效性指标"],["2年时AQLQ较基线平均变化的差异","第2年","有效性指标"],["2年时ACQ-5较基线平均变化的差异","第2年","有效性指标"],["2年时BD后FEV1较基线平均变化的差异。n2年时BD前FEV1较基线平均变化的差异。","第2年","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	曹彬	学位	医学博士	职称	主任医师
	电话	13911318339	Email	caobin_ben@163.com	邮政地址	北京市-北京市-朝阳区樱花园东街2号
	邮编	100029	单位名称	中日友好医院

[["中日友好医院","曹彬","中国","北京市","北京市"],["杭州市第一人民医院","王利民、蒋春明","中国","浙江省","杭州市"],["浙江大学医学院附属第二医院","黄华琼","中国","浙江省","杭州市"],["中南大学湘雅医院","潘频华","中国","湖南省","长沙市"],["中南大学湘雅三院","孙圣华","中国","湖南省","长沙市"],["四川大学华西医院","文富强","中国","四川省","成都市"],["河南省人民医院","张晓菊","中国","河南省","郑州市"],["徐州医科大学附属医院","陈碧","中国","江苏省","徐州市"],["上海交通大学医学院附属瑞金医院","汤葳","中国","上海市","上海市"],["华中科技大学同济医学院附属协和医院","周琼","中国","湖北省","武汉市"],["北京朝阳医院","黄克武","中国","北京市","北京市"],["复旦大学附属中山医院","金美玲","中国","上海市","上海市"],["福建医科大学附属协和医院","陈湘琦","中国","福建省","福州市"],["中山大学附属第一医院","郭禹标","中国","广东省","广州市"],["天津市第一中心医院","蒋萍","中国","天津市","天津市"],["华中科技大学同济医学院附属同济医院","张惠兰","中国","湖北省","武汉市"],["郑州大学第一附属医院","许爱国","中国","河南省","郑州市"],["重庆医科大学第二附属医院","兰箭","中国","重庆市","重庆市"],["山东省立医院","刘毅","中国","山东省","济南市"],["河北省中石油中心医院","刘政","中国","河北省","廊坊市"],["新疆维吾尔自治区中医医院","李风森","中国","新疆维吾尔自治区","乌鲁木齐市"],["广州医科大学附属第一医院","陈如冲","中国","广东省","广州市"],["广州医科大学附属第三医院","魏立平","中国","广东省","广州市"],["University of Nebraska Medical Center","Jill Poole","United States","Nebraska","Nebraska"],["Northwell Health, LLC","Mina Makaryus","United States","New York","New York"],["University of Iowa Health Care","Spyridon Fortis","United States","Iowa","Iowa"],["Brigham and Women's Hospital","Elliot Israel","United States","Massachusetts","Massachusetts"],["University of Michigan","Arjun Mohan","United States","Michigan","Michigan"],["Envision Trials LLC","Rafael Valdespino","United States","Florida","Florida"],["Montefiore Medical Center (MMC)","Golda Hudes","United States","New York","New York"],["VAMC Gainesville","Eric Papierniak","United States","Florida","Florida"],["Innovative Research of West Florida, Inc.","Miguel Trevino","United States","Florida","Florida"],["Bernstein Clinical Research Center, LLC","David Bernstein","United States","Ohio","Ohio"],["Woodland Clinic","Rajan Merchant","United States","California","California"],["Clinical Trials Center of Middle Tennessee","Aaron Milstone","United States","Tennessee","Tennessee"],["Montana Medical Research, Inc.","Carl Thornblade","United States","Montana","Montana"],["University of Florida","Vandana Seeram","United States","Florida","Florida"],["AA MRC LLC Ahmed Arif Medical Research Center","Ahmed Arif","United States","Michigan","Michigan"],["Integrated Clinical Trial Services, Inc.","James Coggi","United States","Iowa","Iowa"],["Synergy Healthcare, LLC","Patrick Weston","United States","Florida","Florida"],["Epic Medical Research Bedford","Haresh Boghara","United States","Texas","Texas"],["Legacy Clinical Trials of Oklahoma City","Christopher Harris","United States","Oklahoma","Oklahoma"],["Cullman Clinical Trials","Gordon Warner","United States","Alabama","Alabama"],["ORSO Health","Jennifer Hill","United States","Arizona","Arizona"],["3Sync Research","Leila Yoonessi","United States","California","California"],["3Sync Research","Meada Pakour","United States","California","California"],["ORSO Health","Mohammad Ali Doroudchi","United States","California","California"],["Gartnavel General Hospital","Rekha Chaudhuri","United Kingdom","Strathclyde","Strathclyde"],["Southmead Hospital","Rahul Shrimanker","United Kingdom","Avon","Avon"],["Addenbrooke's Hospital","Robin Gore","United Kingdom","Cambridgeshire","Cambridge"],["Glenfield Hospital","Shams Un Nisa Naveed","United Kingdom","Leicestershire","Leicester"],["Queen Alexandra Hospital","Thomas Brown","United Kingdom","Hampshire","Portsmouth"],["Guy's Hospital","David Jackson","United Kingdom","Greater London","London"],["Lister Hospital","Uruj Hoda","United Kingdom","Hertfordshire","Stevenage"],["Sheikh Shakbout Medical City","Abbas Ahmed","United Arab Emirates","Abu Dhabi","Abu Dhabi"],["Sheikh Khalifa Medical City","Tufail Muhammad","United Arab Emirates","Abu Dhabi","Abu Dhabi"],["Tawam Hospital","Kashkousha Ramzi","United Arab Emirates","Abu Dhabi","Al Ain"],["Hospital Universitari i Politecnic La Fe","Miguel Angel Diaz Palacios","Spain","Valencia","Valencia"],["Hospital Universitario Fundacion Alcorcon","Ana Rosado Ingelmo","Spain","Alcorcon","Madrid"],["Hospital Universitario de Navarra","Francisco Javier Campano Lancharro","Spain","Pamplona","Navarra"],["Hospital Universitari Germans Trias i Pujol","Carlos Martinez Rivera","Spain","Badalona","Barcelona"],["Hospital Universitario Marques de Valdecilla","Juan Luis Garcia Rivero","Spain","Santander","Cantabria"],["Hospital Universitario 12 de Octubre","Ismael Garcia Moguel","Spain","Madrid","Madrid"],["Hospital Clinic de Barcelona","Irina Diana Bobolea","Spain","Barcelona","Barcelona"],["Hospital Universitario Virgen de las Nieves","Concepcion Morales Garcia","Spain","Granada","Granada"],["Hospital Universitario Lucus Augusti","Luis Perez de Llano","Spain","Lugo","Lugo"],["FutureMeds ES Viamed Madrid","Jesus Fernandez Frances","Spain","Madrid","Madrid"],["Hospital Sant Joan de Deu","Jaime Lozano Blasco","Spain","Esplugues de Llobregat","Barcelona"],["Hospital Vithas Xanit Internacional","Gustavo Adolfo de Luiz Martinez","Spain","Benalmádena","Málaga"],["Pectus Respiratory Health Girona","Juan Roldan Sanchez","Spain","Barcelona","Barcelona"],["Hospital del Mar","Pilar Ausin Herrero","Spain","Barcelona","Barcelona"],["Hospital Universitari Son Espases","Francisco de Borja Garcia-Cosio Piqueras","Spain","Palma de Mallorca","Baleares"],["Hospital Universitario de La Princesa","Carolina Cisneros Serrano","Spain","Madrid","Madrid"],["Hospital Universitario Miguel Servet","Marta Marin Oto","Spain","Zaragoza","Zaragoza"],["Hospital Universitario Virgen Macarena","Agustin Valido Morales","Spain","Sevilla","Sevilla"],["Hospital Universitario Infanta Leonor","Ismael Ali Garcia","Spain","Madrid","Madrid"],["Hospital Universitario San Pedro","Carlos Ruiz Martinez","Spain","Logrorio","La Rioja"],["Hospital Memorial Publio Cordon","Lorena Aida Comeche Casanova","Spain","Pozuelo de Alarcón","Madrid"],["King Fahad Medical City","Al-Lehebi Riyad","Saudi Arabia","Riyadh","Riyadh"],["King Saud University Medical City","Alshehri Moayad","Saudi Arabia","Riyadh","Riyadh"],["King Abdulaziz University Hospital","Habis Yahya","Saudi Arabia","Makkah","Jeddah"],["S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L","Liliana Duca","Romania","Brasov","Brasov"],["Theramed Healthcare SRL","Ioana Agache","Romania","Brasov","Brasov"],["S.C Policlinica de Diagnostic Rapid S.A","Cristina Mihaela Ciobanu","Romania","Brasov","Brasov"],["Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova","Dragos Nicolosu","Romania","Craiova","Dolj"],["Institutul de Pneumoftiziologie","Roxana Nemes","Romania","Bucuresti","Bucuresti"],["Delta Health Care S.R.L","Mihaela Oros","Romania","Bucuresti","Bucuresti"],["Centrul Medical Unirea S.R.L","Corina Steluta Popa","Romania","Brasov","Brasov"],["Seoul National University Bundang Hospital","Sae-Hoon Kim","Korea, Republic of","Gyeonggi-do","Seongnam"],["Asan Medical Center","Tae Bum Kim","Korea, Republic of","Seoul","Seoul"],["Seoul National University Hospital","Heung-Woo Park","Korea, Republic of","Seoul","Seoul"],["Ajou University Hospital","Yoo-Seob Shin","Korea, Republic of","Gyeonggi-do","Suwon"],["Samsung Medical Center","Byung-Jae Lee","Korea, Republic of","Seoul","Seoul"],["Konkuk University Medical Center","Kwang Ha Yoo","Korea, Republic of","Seoul","Seoul"],["Yeungnam University Hospital","Jong Geol Jang","Korea, Republic of","Daegu","Daegu"],["Azienda Ospedaliero Universitaria delle Marche","Maria Beatrice Bilo","Italy","Ancona","Ancona"],["Fondazione Salvatore Maugeri - Clinica Del Lavoro E Della Riabilitazione IRCCS - Istituto Scientific","Dina Visca","Italy","Varese","Tradate"],["IRCCS Ospedale Policlinico San Martino","Diego Bagnasco","Italy","Genova","Genova"],["Centro Ricerche Cliniche di Verona s.r.l.","Marco Caminati","Italy","Verona","Verona"],["Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari","Giovanna Carpagnano","Italy","Bari","Bari"],["Azienda Ospedaliero Universitaria Renato Dulbecco","Girolamo Pelaia","Italy","Catanzaro","Catanzaro"],["Azienda Ospedaliera Universitaria Careggi","Alessandra Vultaggio","Italy","Firenze","Florenze"],["Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza","Matteo Bonini","Italy","Roma","Roma"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Cristiano Caruso","Italy","Roma","Roma"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Laura Pini","Italy","Brescia","Brescia"],["Azienda Ospedaliero Universitaria Policlinico “Gaspare Rodolico - San Marco” (Presidio G. Rodolico)","Claudia Crimi","Italy","Catania","Catania"],["Università di Cagliari-Presidio Policlinico Monserrato","Stefano Del Giacco","Italy","Cagliari","Monserrato"],["Istituto Clinico Humanitas","Enrico Heffler","Italy","Milano","Rozzano"],["Azienda Ospedaliero Universitaria delle Marche","Maria Beatrice Bilo","Italy","Ancona","Ancona"],["Cork University Hospital","Desmond Murphy","Ireland","Cork","Cork"],["Our Lady of Lourdes","Elaine Hayes","Ireland","Louth","Drogheda"],["Connolly Hospital - Blanchardstown","Abirami Subramaniam","Ireland","Dublin","Dublin"],["Beaumont Hospital","Richard Costello","Ireland","Dublin","Dublin"],["Tallaght University Hospital","Patrick Mitchell","Ireland","Dublin","Dublin"],["Midland Regional Hospital Mullingar","Junaid Khan","Ireland","Westmeath","Mullingar"],["Praxis fuer Pneumologie und Allergologie","Gerhard Hoheisel","Germany","Sachsen","Leipzig"],["POIS Sachsen GmbH","Falk Brunner","Germany","Sachsen","Leipzig"],["IKF Pneumologie Mainz","Stephanie Korn","Germany","Rheinland Pfalz","Mainz"],["Pneumologisches Studienzentrum MVZ","Markus Becker","Germany","Berlin","Berlin"],["KPPK Studienzentrum","Olaf Schmidt","Germany","Rheinland Pfalz","Bendorf"],["MECS GmbH","Thomas Schultz","Germany","Berlin","Berlin"],["Studienzentrum Dr. Keller","Claus Keller","Germany","Hessen","Frankfurt am Main"],["Klinische Forschung Hannover-Mitte GmbH - Pratia Germany","Jan Wagner","Germany","Niedersachsen","Hannover"],["CH de Cannes","Fabien Rolland","France","Alpes Maritimes","Cannes"],["Centre Hospitalier du Pays d'Aix","Youssef Trigui","France","Bouches-du-Rh？ne","Aix en Provence"],["CHU de Strasbourg - Nouvel Hopital Civil","Naji Khayath","France","Bas Rhin","Strasbourg Cedex"],["CHRU de Brest - H？pital Morvan","Pierrick Cros","France","Finistere","Brest"],["H0pital Nord - CHU Marseille","Pascal Chanez","France","Bouches-du-Rh？ne","Marseille"],["CHU de Grenoble - Hopital Nord","Christel Saint Raymond","France","Isere","Grenoble Cedex 09"],["Hopital Cochin","Frédérique Aubourg","France","Paris","Paris"],["CHU de Brest - Hopital de la Cavale Blanche","Raphael Le Mao","France","Finistere","Brest"],["Fakultni nemocnice Brno","Sova Milan","Czech Republic","South Moravian","Brno"],["MediTrial s.r.o","Kopecky Petr","Czech Republic","South Bohemian","Jindrichuv Hradec"],["MUDr. Ilona Pavlisova s.r.o.","Pavlisova Ilona","Czech Republic","South Moravian","Miroslav"],["CARe Clinic","Badenhorst Josias","Canada","Alberta","Red Deer"],["Dynamic Drug Advancement","Philteos George","Canada","Ontario","Ajax"],["C.I.C. Saint Laurent","Coman Isabel","Canada","Quebec","Saint-Laurent"],["Jewish General Hospital","Zhao Nan","Canada","Quebec","Montreal"],["SHATPPD","Svetoslav Dachev","Bulgaria","Ruse","Ruse"],["Medical Centre Pratia Clinic EOOD","Iskra Velichkova","Bulgaria","Varna","Varna"],["Medical Center Hera EOOD","Kiril Palaveev","Bulgaria","Sofia","Sofia"],["Medical Center Iskar EOOD","Mariana Mandazhieva - Pepelanova","Bulgaria","Sofia","Sofia"],["DCC","Borislava Krusheva","Bulgaria","Sofia","Sofia"],["Haelan Care 4 Medical Center EOOD","Pavlina Peneva","Bulgaria","Varna","Varna"],["Medical Center- Prolet Ltd","Stefan Dimitrov","Bulgaria","Ruse","Ruse"],["AZ Sint-Maarten","Muriel Lins","Belgium","Antwerp","Mechelen"],["UZA","Katrien Eger","Belgium","Antwerp","Edegem"],["Pneumocare","Jean Benoit Martinot","Belgium","Namur","Namur"],["Cliniques Universitaires Saint-Luc","Charles Pilette","Belgium","Brussels Capital Region","Bruxelles"],["CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE","Florence Schleich","Belgium","Liège","Liege"],["HUB Erasme","Alain Michils","Belgium","Brussels Capital Region","Brussels"],["De Meulemeester, Marc","Marc de Meulemeester","Belgium","Hainaut","Gozee"],["Canopy Clinical Northern Beaches","Denissa Loh","Australia","New South Wales","Brookvale"],["Canopy Clinical Sutherland Shire","Karen Kaluhin","Australia","New South Wales","Miranda"],["TrialsWest Mandurah","Peter Bremner","Australia","Western Australia","Western Australia"],["Paratus Clinical Melbourne","Kianoosh Samie","Australia","Victoria","Melbourne"],["University of the Sunshine Coast Clinical Trials Centre","Indika Leelasena","Australia","Queensland","Meadowbrook"],["Canopy Clinical Altona North","Oscar Walsh","Australia","Victoria","Altona North"],["Emeritus Research, Melbourne","Rishi Shah","Australia","Victoria","Camberwell"],["Queensland Allergy Services","Peter Smith","Australia","Queensland","Southport"],["The Prince Charles Hospital","Timothy Riddles","Australia","Queensland","Chermside"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中日友好医院药物（器械）临床试验伦理委员会","同意","2026-06-11"]]

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: 71 ； 国际: 456 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 4 ；
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：2026-03-13；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2026-04-08；
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；