杭州注射用RO7837195II期临床试验-一项在中度至重度活动性溃疡性结肠炎患者中评估RO7837195有效性、安全性和药代动力学的IIb期、多中心、双盲 、安慰剂对照、诱导期加扩展活性治疗期研究

登记号	CTR20254876	试验状态	进行中
申请人联系人	鞠佩佩	首次公示信息日期	2025-12-10
申请人名称	Genentech, Inc./ 罗氏（中国）投资有限公司/ Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

登记号	CTR20254876
相关登记号	暂无
药物名称	注射用RO7837195
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	中度至重度活动性溃疡性结肠炎
试验专业题目	一项在中度至重度活动性溃疡性结肠炎患者中评估RO7837195有效性、安全性和药代动力学的IIb期、多中心、双盲 、安慰剂对照、诱导期加扩展活性治疗期研究
试验通俗题目	一项在中度至重度活动性溃疡性结肠炎患者中评估RO7837195有效性、安全性和药代动力学的IIb期、多中心、双盲 、安慰剂对照、诱导期加扩展活性治疗期研究
试验方案编号	GA45977	方案最新版本号	第1版
版本日期:	2025-04-05	方案是否为联合用药	否

申请人名称	[["Genentech, Inc."],["罗氏（中国）投资有限公司"],["Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC"]]
联系人姓名	鞠佩佩	联系人座机	021-28923546	联系人手机号	18621759973
联系人Email	Peipei.ju@roche.com	联系人邮政地址	上海市-上海市-浦东新区龙东大道1100号	联系人邮编	201203

本研究旨在评价RO7837195（一种抗p40/TL1a双特异性抗体）与安慰剂相比在既往传统和/或高阶疗法失败的中度至重度活动性溃疡性结肠炎（UC）患者中的有效性、安全性和药代动力学特征。

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	[["签署知情同意书"],["签署知情同意书时年龄≥18岁或符合当地标准的成人"],["能够依从研究方案，包括（受试者或照料者/护理者）愿意并能够使用电子设备收集患者报告结局数据"],["同意遵守方案中所述的避孕要求"],["在筛选前至少3个月确诊UC，并在筛选期间有临床和内镜证据得以证实UC诊断应得到组织病理学证实，并在组织病理学报告中记录。如果未获得既往组织病理学报告，则应在筛选时进行组织病理学检查"],["筛选期间进行的基线内镜检查（软式乙状结肠镜检查或结肠镜检查）显示距离肛缘延伸至少15 cm的UC证据。需注意的是，排除孤立性直肠炎"],["筛选前2年内接受过结肠镜检查，或愿意在筛选时接受结肠镜检查，而不是软式乙状结肠镜检查，结肠镜检查应满足以下所有条件：n–确认病变范围，定义为1）左半结肠炎（炎症累及脾曲以远），2）广泛结肠炎（炎症累及脾曲以近但未达全结肠），或3）全结肠炎（炎症累及全结肠）n–切除任何腺瘤性息肉n–对于所有病程>8年或者存在肠癌风险因素的溃疡性结肠炎患者，根据当地标准治疗监测异型增生"],["筛选期间证实患有中度至重度活动性UC，定义为mMS 5-9分，其中内镜单项评分≥2分"],["对于正在接受允许的口服5-氨基水杨酸（5-ASA）、口服糖皮质激素、口服益生菌、硫唑嘌呤（AZA）、6-巯嘌呤（6-MP）或甲氨蝶呤（MTX）背景UC治疗的患者：应在以下时间段内保持稳定剂量n–口服5-ASA剂量在筛选内镜检查前保持稳定≥2周。n–口服糖皮质激素剂量≤20 mg/d泼尼松（或等效剂量），且在筛选内镜检查前保持稳定≥2周。n–口服益生菌（例如Culturelle、布拉氏酵母菌）剂量在筛选内镜检查前保持稳定≥2周。n–AZA、6-MP或MTX剂量在筛选内镜检查前保持稳定≥12周。"],["既往高阶疗法失败和/或传统治疗失败"]]
排除标准	[["处于妊娠期或哺乳期，或者在研究期间或需要避孕的时间段内有备孕计划。有生育能力的受试者在筛选时的血清妊娠试验结果必须呈阴性，且在第0周时的尿液或血清妊娠试验结果必须呈阴性"],["经研究者判断，筛选前2年内有物质滥用史"],["UC既往接受过广泛结肠切除术、结肠次全切除术或全结肠切除术，或计划接受UC手术"],["既往或当前接受回肠造口术或结肠造瘘术"],["诊断为克罗恩病或未定型结肠炎"],["疑似缺血性结肠炎、放射性结肠炎或显微镜下结肠炎"],["筛选前12个月内诊断为中毒性巨结肠"],["既往或当前存在瘘管或腹部脓肿"],["病史或当前证据表明有未切除的腺瘤性结肠息肉或结肠黏膜异型增生"],["任何妨碍内镜评价的结肠狭窄"],["确诊或疑似患有原发性硬化性胆管炎"],["已知或疑似对生物制剂（包括RO7837195）或其辅料产生变态反应或过敏反应史"],["筛选前接受过RO7837195治疗"],["筛选前接受过靶向作用于TL1a的高阶疗法"],["筛选前对靶向作用于IL-12和/或IL-23的UC高阶疗法（例如，乌司奴单抗、mirikizumab、risankizumab、古塞奇尤单抗）应答不足、失应答或无法耐受"],["在筛选内镜检查前8周或5个半衰期内（以时间较长者为准）使用获批的生物制剂治疗UC"],["在筛选内镜检查前2周或5个半衰期内（以时间较长者为准）使用获批的非生物制剂治疗UC"],["在筛选前2周或试验药物的5个半衰期内（以时间较长者为准）参加过涉及非生物制剂的试验性研究，或在筛选前8周或试验药物的5个半衰期内（以时间较长者为准）参加过涉及生物制剂（包括疫苗）的试验性研究"],["在筛选内镜检查前2周内接受IV糖皮质激素治疗"],["在筛选内镜检查前2周内接受糖皮质激素灌肠剂或栓剂和/或局部用（直肠）5-ASA制剂治疗"],["在筛选内镜检查前2周内或计划在研究期间接受选择性白细胞吸附治疗（例如，Adacolumn&reg;吸附性血液净化器）"],["在筛选前12个月内接受B细胞或T细胞清除剂（例如，利妥昔单抗、visilizumab、alemtuzumab）治疗，或筛选内镜检查时存在持续性靶向性的淋巴细胞清除的证据"],["长期使用非甾体类抗炎药（NSAID）"],["在筛选前12个月内接种卡介苗（BCG）或在筛选前12周内接种任何其他活菌或活病毒疫苗，或者计划在研究期间接种此类疫苗"],["在筛选前4周内接受免疫球蛋白或血液制品治疗，或存在任何可能需要在研究期间接受此类治疗的疾病，除非研究者与医学监查员协商后认为治疗可接受"],["存在研究者评估认为可能需要在研究期间接受>20 mg/d泼尼松（或等效剂量）治疗的除UC以外的疾病"],["存在研究者认为可能混淆研究结果或危害受试者安全的无法控制的重大疾病或共存疾病，如心脏（例如，纽约心脏病协会III/IV级中度至重度心力衰竭，或左心室射血分数<35%的历史证据）、肺部、肾脏、肝脏、内分泌或胃肠道疾病（不包括UC）"],["筛选期间住院治疗（非择期原因）"],["可逆性后部脑病综合征（PRES）病史"],["恶性肿瘤或淋巴增生性疾病病史"],["筛选发现，既往或当前存在完全左束支传导阻滞、二度或三度房室传导阻滞或研究者认为具有临床意义的其他异常ECG结果"],["采用Fridericia公式校正的QT间期（QTcF）>450 ms（男性）或QTcF>470 ms（女性）n对于QRS>120的男性或女性：QTcF>480 ms"],["存在获得性或先天性免疫缺陷"],["既往或当前患有慢性或复发性感染性疾病，包括但不限于非结核分枝杆菌感染、组织胞浆菌病、球孢子菌病、复发性尿路感染、引流或感染的皮肤伤口或溃疡，或严重机会性感染（例如，巨细胞病毒性结肠炎、卡氏肺囊虫病、曲霉病）"],["筛选时HIV抗体检测结果呈阳性"],["筛选时丙型肝炎病毒（HCV）抗体检测结果呈阳性，且HCV RNA检测结果呈阳性"],["筛选时乙型肝炎（HBV）感染检查结果呈阳性"],["筛选期间或筛选前3个月内结核病（TB）阳性，定义为根据疾病控制和预防中心指南，干扰素γ释放试验（IGRA）（例如，QuantiFERON&reg;-TB Gold或T-SPOT.TB）阳性，或者如果IGRA不可及，纯化蛋白衍生物（PPD）皮肤试验阳性"],["筛选时或筛选前4周内有艰难梭菌（通过艰难梭菌毒素检测进行评估）或其他肠道病原体（通过粪便细菌培养、虫卵和寄生虫评价进行评估）的证据"],["筛选时或筛选前4周内通过组织学检查或免疫组化分析（根据当地标准）进行的结肠活组织检查显示巨细胞病毒（CMV）阳性仅当临床高度怀疑CMV以及确定是否需要治疗CMV时，才需要在筛选评价期间由实验室确认结肠活组织检查样本中是否存在CMV"],["筛选期间实验室检查（血液学、血清生化和尿液分析）发现具有临床意义的异常，研究者认为可能对接受研究治疗的受试者造成额外风险"],["ALT、AST、ALP或总胆红素>2×正常值上限（ULN），或存在研究者判断具有临床意义的肝合成功能检查异常n不排除患有非结合高胆红素血症的已知吉尔伯特综合征患者"],["ANC<1.5×10^9/L（1500/μL）"],["绝对淋巴细胞计数<0.8×10^9/L（800/μL）"],["血小板计数<100×10^9/L（100,000/ μL）"],["血红蛋白<90 g/L（9 g/dL）"],["肌酐清除率<30 mL/min"],["外周静脉通路难以建立"],["研究中心或申办者雇员，或者研究中心或申办者雇员的直系亲属"]]

试验药	[["中文通用名:注射用RO7837195 英文通用名:RO7837195injection 商品名称:NA","剂型:用于IV和SC给药的冻干制剂 规格:100mg/瓶 用法用量:首次剂量通过IV输注给药，从第4周开始，后续剂量通过SC注射给药。 用药时程:共48周"]] 序号 名称 用法
对照药	[["中文通用名:RO7837195安慰剂 英文通用名:RO7837195Placebo 商品名称:NA","剂型:SC给药溶液 规格:不适用 用法用量:SC注射给药 用药时程:共48周"]] 序号 名称 用法

主要终点指标及评价时间	[["第12周时达到临床缓解，其中临床缓解定义为mMS≤2分，且Mayo单项评分满足以下标准： n– 排便次数单项评分≤1分 n– 便血单项评分=0分 n– 内镜单项评分≤1分（改良评分1分，以排除易脆）","第12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	[["第12周时达到临床应答n第12周时达到内镜改善n第12周时达到内镜缓解","第12周","有效性指标"],["不良事件的发生率和严重程度，其中严重程度根据CTCAE v5.0分级量表确定n特定生命体征较基线的变化n特定临床实验室检查结果较基线的变化","试验期间","安全性指标"],["特定时间点血清中的RO7837195浓度","特定时间点","有效性指标+安全性指标"],["基线时ADA阳性率和研究期间ADA发生率","试验期间","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	曹倩	学位	博士	职称	主任医师
	电话	13588706896	Email	caoq@srrh.com	邮政地址	浙江省-杭州市-钱塘区下沙路368号
	邮编	310019	单位名称	浙江大学医学院附属邵逸夫医院

[["浙江大学医学院附属邵逸夫医院","曹倩","中国","浙江省","杭州市"],["四川省医学科学院-四川省人民医院","李良平","中国","四川省","成都市"],["郑州大学第二附属医院","冯百岁","中国","河南省","郑州市"],["吉林大学第一医院","唐彤宇","中国","吉林省","长春市"],["滨州医学院附属医院","刘成霞","中国","山东省","滨州市"],["宁波大学附属第一医院","丁小云","中国","浙江省","宁波市"],["武汉大学人民医院（湖北省人民医院","安萍","中国","湖北省","武汉市"],["福建医科大学附属第一医院","王承党","中国","福建省","福州市"],["厦门大学附属中山医院","胡益群","中国","福建省","厦门市"],["中山大学附属第六医院","高翔","中国","广东省","广州市"],["广州医科大学附属第二医院","杨辉","中国","广东省","广州市"],["惠州市中心人民医院","陈惠新","中国","广东省","惠州市"],["ASST Rhodense, Rho Memorial Hospital","Saibeni Simone","意大利","Rho","Milano"],["Chosun University Hospital","Lee Jun","韩国","NA","Gwangju"],["The Catholic University of Korea, Eunpyeong St. Mary’s Hospital","Jung Sunghoon","韩国","NA","Seoul"],["Groupe Hospitalier Ambroise Pare - Institut des MICI","Stefanescu Carmen","法国","Hauts de Seine","Neuilly Sur Seine"],["WSD MEDI Clinical sp z o o","Krogulecki Michal","波兰","NA","Warszawa"],["Newdata Clinical Trials","Vianey Callado Franca Alex","巴西","Sergipe","Aracaju"],["CHU Saint Etienne - H？pital Nord","Roblin Xavier","法国","Saint Etienne","Loire"],["SOLUMED Centrum Medyczne","Andrzejewska Magdalena","波兰","NA","Poznan"],["Yonsei University Wonju Severance Christian Hospital","Kim Hyun-Soo","韩国","Gangwon-do","Wonju-si"],["Asan Medical Center","Ye Byong Duk","韩国","NA","Seoul"],["BR Trials - Ensaios Clínicos e Consultoria","Gomes da Silva Junior Roberto","巴西","Sao Paulo","Sao Paulo"],["Bankstown-Lidcombe Hospital","Samuel Douglas","澳大利亚","New South Wales","Bankstown"],["Kangbuk Samsung Hospital","Park Dong Il","韩国","NA","Seoul"],["Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'？le-de-Montréal","Heron Valerie","加拿大","Quebec","Montreal"],["HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará","Campelo Braga Lúcia","巴西","Ceará","Fortaleza"],["Universitaetsklinikum Regensburg","Kandulski Arne","德国","Bayern","Regensburg"],["NHO Kanazawa Medical Center","Kagaya Takashi","日本","Ishikawa-Ken","Kanazawa-shi"],["University of Rochester - PARENT","Saubermann Lawrence","美国","New York","Rochester"],["Centro Medico Clinico Quirurgico Especializado en Investigacion","Cruz Neri Roberto Ulises","墨西哥","Jalisco","Tlajomulco de Zuniga"],["Hospital de Clínicas de Porto Alegre","dos Santos Harlacher Luciana","巴西","Rio Grande do Sul","Porto Alegre"],["Addenbrooke's Hospital","Raine Timothy","英国","Cambridgeshire","Cambridge"],["Fiona Stanley Hospital","Thin Lena","澳大利亚","Western Australia","Murdoch"],["PreventaMed s.r.o.","Pumprla Jiri","捷克","NA","Olomouc"],["Clinica de Investigacion en Reumatologia y Obesidad S.C.","Maldonado Martinez Juan Manuel","墨西哥","Jalisco","Guadalajara"],["FAICIC S. de R.L. de C.V.","Cruz Palacios Aracely","墨西哥","Veracruz","Veracruz"],["Universitaetsklinikum Frankfurt Goethe-Universitaet","Blumenstein Irina","德国","Hessen","Frankfurt am Main"],["Royal Prince Alfred Hospital","Corte Crispin","澳大利亚","New South Wales","Camperdown"],["CECIP - Centro de Estudos Clínicos do Interior Paulista","Felicio Otaviano","巴西","Sao Paulo","Jaú"],["Associa？？o Paranaense de Cultura – APC","Kotze Paulo Gustavo","巴西","Paraná","Curitiba"],["Medon Clinical Research Sp Z O O","Bochenek Mularczyk Anna","波兰","NA","Warszawa"],["CDC - Centro Digestivo de Curitiba","Ramos Junior Odery","巴西","Paraná","Curitiba"],["Royal Liverpool University Hospital","Razanskaite Violeta","英国","Merseyside","Liverpool"],["CHU Clermont Ferrand - Hopital d'Estaing","Buisson Anthony","法国","Puy de Dome","Clermont Ferrand cedex 1"],["Clinsante S.C. Osrodek Badan Klinicznych","Wiatr Michal","波兰","NA","Bydgoszcz"],["Clinical Research of Osceola","Atiquzzaman Basher","美国","Florida","Kissimmee"],["Kokikai Tsujinaka Hospital Kashiwanoha","Takeuchi Ken","日本","Chiba-Ken","Kashiwa-shi"],["Kojunkai Daido Clinic","Nishikawa Takahiro","日本","Aichi-Ken","Nagoya-shi"],["Provita Poliklinika sp. z o.o","Bugajski Marek","波兰","NA","Warszawa"],["Hospital Sirio Libanes","de Sousa Carlos Alexandre","巴西","Sao Paulo","S？o Paulo"],["Samsung Medical Center","Hong SungNoh","韩国","NA","Seoul"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Gasbarrini Antonio","意大利","Roma","Rome"],["I.R.C.C.S Policlinico San Donato","Annese Vito","意大利","Milano","San Donato Milanese (MI)"],["Monroe Biomedical Research","Igbinadolor Awawu","美国","North Carolina","Monroe"],["University of Utah Hospitals & Clinics","Valentine John","美国","Utah","Salt Lake City"],["Ospedale Mauriziano Umberto I","Daperno Marco","意大利","Torino","Torino"],["Ospedale Sacro Cuore Don Calabria","Variola Angela","意大利","Verona","Negrar"],["Shinseikai Sai Gastroenterology, Proctology","Sai Soken","日本","Osaka-Fu","Fujidera-shi"],["S. R. Kalla Memorial Gastro & General Hospital","Kalla Mukesh","印度","Rajasthan","Jaipur"],["Intercity Gastroenterology","Shahzad Ghulamullah","美国","New York","Fresh Meadows"],["Hospital Felicio Rocho","de Paula Guimar？es Bai Carolinaa","巴西","Minas Gerais","Belo Horizonte"],["Peak Gastroenterology Associates","Patel Bhaktasharan","美国","Colorado","Colorado Springs"],["Mz Badania Slowik Zymla Sp J","Zymla Maciej","波兰","NA","Knorow"],["Kingsway Hospital","Patil Samir","印度","Maharashtra","Nagpur"],["Kaiser Clinica","Kaiser Junior Roberto Luiz","巴西","Sao Paulo","Sao Jose do Rio Preto"],["Nemocnice Slany","Peterka Martin","捷克","NA","Slany"],["Twoja Przychodnia-Szczecińskie Centrum Medyczne","Gawdis Wojnarska Beata","波兰","NA","Szczecin"],["The Catholic University of Korea, Daejeon St. Mary's Hospital","Kang Sang Bum","韩国","NA","Daejeon"],["Istituto Clinico Humanitas","Armuzzi Alessandro","意大利","Milano","Rozzano"],["NSZOZ Termedica – Centrum Badan Klinicznych","Mazur Maciej","波兰","NA","Poznan"],["Velocity Skierniewice Sp. z o.o","Jastrzebski Dariusz","波兰","NA","Skierniewice"],["Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji","Rydzewska-Wyszkowska Grazyna","波兰","NA","Warszawa"],["Ospedale San Raffaele","Danese Silvio","意大利","Milano","Milano"],["Fondazione Poliambulanza Istituto Ospedaliero","Cesaro Paola","波兰","Brescia","Brescia"],["Asian Institute of Gastroenterology","Banerjee Rupa","印度","Andhra Pradesh","Hyderabad"],["ALLMEDICA Badania Kliniczne Sp. zo.o. Sp.K","Krzyzanowski Mikolaj","波兰","NA","Nowy Targ"],["Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan","Pinzon Te Lourdes Lol-Be","墨西哥","Yucatán","Merida"],["Guy's Hospital","Samaan Mark","英国","Greater London","London"],["Azienda Ospedale-Università di Padova","Savarino Edoardo Vincenzo","意大利","Padova","Padova"],["L2IP – Instituto de Pesquisas Clínicas Ltda.","Teixeira de Campos Luciana","巴西","Distrito Federal","Brasilia"],["Przychodnia Vistamed","Frysna Bernardeta","波兰","NA","Wroclaw"],["Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.","Vega Fonseca Jose Luis","墨西哥","San Luis Potos","San Luis Potosi"],["NHO Osaka National Hospital","Sakakibara Yuko","日本","Osaka-Fu","Osaka-shi"],["Saga University Hospital","Esaki Motohiro","日本","Saga-Ken","Saga-shi"],["Fukuoka University Hospital","Hirai Fumihito","日本","Fukuoka-Ken","Fukuoka-shi"],["Takamatsu Red Cross Hospital","Tamaki Hiroyuki","日本","Kagawa-Ken","Takamatsu-shi"],["Shree Giriraj Multispeciality Hospital","Mehta Chetan","印度","Gujarat","Rajkot"],["Clinical Research Center Spolka z o. o. Medic-R Sp. k.","Hanczewski Marcin","波兰","NA","Poznan"],["Shared Health","Bernstein Charles","加拿大","Manitoba","Winnipeg"],["University of Chicago Medical Center","Rubin David","美国","Illinois","Chicago"],["Northwestern University School of Medicine","Bellaguarda Emanuelle","美国","Illinois","Chicago"],["Centrum Medyczne LUKA MED.Joanna ？uka","Soltysiak Artur","波兰","NA","Chojnice"],["Centrum Zdrowia MDM","Liszka Dalecki Piotr","美国","NA","Warszawa"],["King's College Hospital","Pavlidis Polychronis","英国","Greater London","Denmark Hill"],["Institute of Post Graduate Medical Education And Research","Sarkar Rajib","印度","West Bengal","Kolkata"],["IAMSPE - Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual","Dourado Poli","巴西","Sao Paulo","Sao Paulo"],["Clinique IMD","Afif Waqqas","加拿大","Quebec","Montreal"],["Chung-Ang University Hospital","Choi Chang-hwan","韩国","NA","Seoul"],["Inje University Haeundae Paik Hospital","Kim Tae-Oh","韩国","NA","Busan"],["Access Research Institute","Muddassir Salman","美国","Florida","Brooksville"],["Medical Associates Research Group, Inc.","Kim Hyun","美国","California","San Diego"],["Chronos Pesquisa Clínica","Clemente Cintia","巴西","Distrito Federal","Brasilia"],["Centre Hospitalier Lyon Sud","Nancey Stephane","法国","Rhone","Pierre Benite cedex"],["Fondazione IRCCS Policlinico San Matteo","Di Sabatino Antonio","意大利","Pavia","Pavia"],["Centrum Medyczne Medis","Klopocka Maria","波兰","NA","Bydgoszcz"],["Twoja Przychodnia Opolskie Centrum Medyczne","Kwinto Marzena","波兰","NA","Opole"],["Hospital Gloria DOr - Hospitais Integrados da Gavea S/A","da Silva Moraes Antonio Carlos","巴西","Rio do Janeiro","Rio de Janeiro"],["NHO Fukuyama Medical Center","Toyokawa Tatsuya","日本","Hiroshima-Ken","Fukuyama-shi"],["London Digestive Disease Institute","Jairath Vipul","加拿大","Ontario","London"],["Royal Melbourne Hospital","Christensen Britt","澳大利亚","Victoria","Parkville VIC"],["Pesquisare Saude","de Sa Rolim Alexander","巴西","Sao Paulo","Santo Andre"],["John Radcliffe Hospital","Cheung Vincent","英国","Oxfordshire","Oxford"],["Hospital Ernesto Dornelles","Flores Cristina","巴西","Rio Grande do Sul","Porto Alegre"],["Royal Victoria Infirmary","Speight Ally","英国","Tyne & Wear","Newcastle upon Tyne"],["Medical Network Spó？ka z o. o., WIP Warsaw IBD Point Profesor Kierkus","Kierkus Jaroslaw","波兰","NA","Warszawa"],["Vita Longa Sp. z.o.o","Ramos Przemyslaw","波兰","NA","Katowice"],["CPQuali Pesquisa Clinica Ltda.","Bandeira Lages Rafael","巴西","Sao Paulo","S？o Paulo"],["Mount Sinai Hospital","Steinhart Hillary","加拿大","Ontario","Toronto"],["University of Arizona College of Medicine","Taleban Sasha","美国","Arizona","Tucson"],["Gastro Care Institute","Tyagi Viviak","美国","California","Lancaster"],["Mater Misericordiae Limited","An Yoon-Kyo","澳大利亚","Queensland","South Brisbane"],["ETG Zamosc","Wojcik Katarzyna","波兰","NA","Zamosc"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["浙江大学医学院附属邵逸夫医学伦理委员会","同意","2025-09-25"],["浙江大学医学院附属邵逸夫医学伦理委员会","同意","2025-11-18"]]

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: 23 ； 国际: 224 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 1 ；
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：2025-08-26；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-09-29；
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；