广州SAR442970注射液II期临床试验-一项在克罗恩病患者中研究SAR442970疗效和安全性的研究

登记号	CTR20253563	试验状态	进行中
申请人联系人	王昕妍	首次公示信息日期	2025-09-04
申请人名称	Sanofi-Aventis Recherche & Développement/ 富启睿医药研发（北京）有限公司/ Sanofi-Aventis Recherche & Développement；Eurofins CDMO (Amatsigroup SAS)

登记号	CTR20253563
相关登记号	暂无
药物名称	SAR442970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	本品拟用于治疗成人中重度克罗恩病
试验专业题目	一项在中重度克罗恩病成人患者中评估SAR442970的疗效和安全性的II期、多中心、随机、双盲、安慰剂对照、剂量范围探索研究
试验通俗题目	一项在克罗恩病患者中研究SAR442970疗效和安全性的研究
试验方案编号	DRI18450	方案最新版本号	修正案01
版本日期:	2025-02-27	方案是否为联合用药	否

申请人名称	[["Sanofi-Aventis Recherche & Développement"],["富启睿医药研发（北京）有限公司"],["Sanofi-Aventis Recherche & Développement；Eurofins CDMO (Amatsigroup SAS)"]]
联系人姓名	王昕妍	联系人座机	010-57323000	联系人手机号	13120730351
联系人Email	Xinyan.Wang@fortrea.com	联系人邮政地址	北京市-北京市-北京市朝阳区酒仙桥路6号院10号楼1至14层101内4层403室	联系人邮编	100015

主要：评估诱导期末不同剂量的SAR442970在内镜应答方面的疗效。 次要：评估诱导期末不同剂量的SAR442970对临床缓解的影响。 评估诱导期末不同剂量的SAR442970对CD的PRO/体征和症状的影响。 评估诱导期末不同剂量的SAR442970对内镜缓解的影响。 评估诱导期末不同剂量的SAR442970对临床缓解和内镜应答复合终点的影响。 评估诱导期末不同剂量的SAR442970对临床应答的影响。 评估诱导期末不同剂量的SAR442970对疾病特异性QoL的影响。 评估CD受试者中不同剂量的SAR442970的PK。 评估不同剂量SAR442970的安全性和耐受性。 评估所有受试者中SAR442970的免疫原性潜力。 评估维持治疗结束时不同剂量的SAR442970对内镜缓解的影响。 评估维持治疗结束时不同剂量的SAR442970对临床缓解的影响。 评估维持治疗结束时不同剂量的SAR442970对内镜应答的影响。 评估维持治疗结束时不同剂量的SAR442970对临床应答的影响。 评估维持治疗结束时不同剂量的SAR442970对临床缓解和内镜应答的影响。

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 75岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["在筛选前至少3个月确诊CD的受试者。必须有恰当的活检（组织学）、内镜检查和/或放射学结果记录，与研究者确定的CD诊断一致。"],["患有中重度活动性CD的受试者"],["必须接受过CD既往治疗（以下“a”或“b”或二者联合）：a) 没有既往AT暴露史，但对以下任何药物的标准治疗应答不充分、失去应答或不耐受：5-ASA、6-MP、AZA、MTX、口服或IV皮质类固醇或皮质类固醇依赖史（定义为无法在CD不复发的情况下成功减量皮质类固醇），或b) 对≥1且≤3种经批准的AT治疗种类，如治疗CD的生物制剂（如抗TNF、抗整联蛋白 [不包括natalizumab（Tysabri®）或口服carotegrast methyl（Carogra®）]、抗IL-12/23、抗IL-23或实验性生物制剂）或小分子药物（如JAKi或S1PRm）有应答不充分、失去应答或不耐受史。必须根据以下时间表中止治疗：- 抗TNF治疗，随机分配前至少8周。- 维得利珠单抗、乌司奴单抗或Rizankizumab治疗，随机分配前至少8周。- 实验性生物制剂，随机分配前至少8周或IMP终末半衰期的5倍时间，以较长者为准。"],["受试者可以正在接受治疗剂量的以下药物：- 口服5-ASA药物：处方剂量必须在筛选期结肠镜检查前稳定至少2周，或在筛选期结肠镜检查前至少2周停止治疗。- 口服皮质类固醇的剂量必须为泼尼松等效剂量≤20 mg/天或布地奈德≤9 mg/天，且其剂量在筛选期结肠镜检查前稳定至少2周，或在筛选期结肠镜检查前至少2周停用。- AZA、6-MP或MTX：如果处方剂量在筛选期结肠镜检查前已稳定至少4周，或者如果停用，必须在筛选期结肠镜检查前已停药至少4周，视为符合入组资格。- 处方抗生素的剂量在筛选期结肠镜检查前已稳定至少4周，或者如果停用，必须在筛选期结肠镜检查前已停药至少4周，视为符合入组资格。"],["男性和女性使用的所有避孕措施应符合当地关于临床研究受试者避孕方法的规定。"]]
排除标准	[["患有活动性UC、不确定性结肠炎、未切除的腺瘤性结肠息肉、结肠粘膜发育不良（低度或高度发育不良）或短肠综合征的受试者。"],["仅涉及胃、十二指肠、空肠或肛周的CD受试者，无结肠或回肠受累。"],["受试者伴有CD的以下持续性并发症：- 瘘管病。- 脓肿（腹部或肛周）。- 症状性肠狭窄。- 以下五个肠段中有两个肠段完全缺失（手术切除或在最近的结肠镜检查中不可见）：末端回肠、右侧结肠、横结肠、乙状结肠和左侧结肠以及直肠。- 暴发性结肠炎。- 中毒性巨结肠。- 或可能需要在入组研究期间进行肠道手术的任何其他表现。- 接受过造口术或有回肠造口袋的受试者。- 患有可能干扰药物吸收的疾病（包括但不限于短肠综合征）的受试者。- 在筛选前三个月内接受过外科肠道切除术，或有>3次肠道切除术史的受试者。"],["根据研究者的判断，无论出于何种原因（包括医学或临床状况），受试者不适合参与，或受试者可能存在不依从研究程序的风险。"]]

试验药	[["中文通用名:SAR442970注射液 英文通用名:SAR442970Injection 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 用药时程:52周的主研究治疗期，包括16周的DB诱导期和36周的DB维持期。OL治疗期在完成16周DB诱导期后在DB维持期任何时间出现临床恶化的符合条件的受试者将有资格转换至OL治疗期。OLLTE期（符合条件的受试者的LTE治疗期最长为104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:不适用 用法用量:皮下注射 用药时程:52周的主研究治疗期，包括16周的DB诱导期和36周的DB维持期。OL治疗期在完成16周DB诱导期后在DB维持期任何时间出现临床恶化的符合条件的受试者将有资格转换至OL治疗期。"]] 序号 名称 用法

主要终点指标及评价时间

[["第16周时达到内镜应答的受试者百分比。内镜应答定义为根据中心阅片SES-CD较基线降低>50%（或基线评分≥4分的孤立性回肠疾病受试者降低至少2分）。","第16周时","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16周时根据CDAI达到临床缓解的受试者百分比。CDAI临床缓解定义为CDAI评分<150。","第16周时","有效性指标"],["第16周时达到PRO-2临床缓解的受试者百分比。PRO-2临床缓解定义为每日平均SF≤3且较基线无恶化以及每日平均AP≤1且较基线无恶化。","第16周时","有效性指标"],["第16周时达到内镜缓解的受试者百分比。内镜缓解定义为根据中心阅片SES-CD≤4分且较基线降低至少2分，同时单个变量的子评分都不>1。","第16周时","有效性指标"],["第16周时达到临床缓解和内镜应答的受试者百分比。CDAI定义为CDAI评分<150，内镜应答定义为根据中心阅片SES-CD较基线降低>50%(或基线评分≥4分的孤立性回肠疾病受试者降低至少2分)","第16周时","有效性指标"],["第16周时达到CDAI临床应答的受试者百分比。CDAI临床应答定义为CDAI较基线降低≥100分。","第16周时","有效性指标"],["第16周IBDQ评分较基线的变化","第16周时","有效性指标"],["第16周FACIT-F评分较基线的变化。","第16周时","有效性指标"],["治疗期间预定时间点的SAR442970血清浓度。","治疗期间","有效性指标+安全性指标"],["诱导期和维持治疗期间以及LTE治疗期间发生任何TEAE的受试者人数和百分比。","诱导期和维持治疗期间以及LTE治疗期间","安全性指标"],["开放标签治疗期间发生任何TEAE的受试者人数和百分比。","开放标签治疗期间","安全性指标"],["ADA发生率随时间的变化。","研究期间","安全性指标"],["第52周时根据中心阅片的SES-CD达到内镜缓解的受试者百分比。内镜缓解定义为根据中心阅片SES-CD≤4分且较基线降低至少2分，同时单个变量的子评分都不>1。","第52周时","有效性指标"],["第52周时达到CDAI临床缓解的受试者百分比。CDAI临床缓解定义为CDAI<150。","第52周时","有效性指标"],["第16周和第52周时达到CDAI临床缓解的受试者百分比。","第16周和第52周","有效性指标"],["第52周时达到内镜应答的受试者百分比。内镜应答定义为根据中心阅片SES-CD较基线降低>50%（或基线评分≥4分的孤立性回肠疾病受试者降低至少2分）。","第52周时","有效性指标"],["第16周和第52周达到内镜应答的受试者百分比。","第16周和第52周","有效性指标"],["第52周时达到CDAI临床应答的受试者百分比。CDAI临床应答定义为CDAI较基线降低≥100分。","第52周时","有效性指标"],["第52周时CDAI<150和中心阅片的SES-CD较基线降低>50%同时达到临床缓解和内镜应答的受试者百分比。","第52周时","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	高翔	学位	博士	职称	主任医师
	电话	13502405878	Email	helen_gao818@163.com	邮政地址	广东省-广州市-广州市天河区员村二横路26号
	邮编	510655	单位名称	中山大学附属第六医院

[["中山大学附属第六医院","高翔","中国","广东省","广州市"],["上海交通大学医学院附属新华医院","葛文松","中国","上海市","上海市"],["中南大学湘雅二医院","王学红","中国","湖南省","长沙市"],["南昌大学第一附属医院","廖旺娣","中国","江西省","南昌市"],["常州市第二人民医院","刘文佳","中国","江苏省","常州市"],["浙江大学医学院附属第二医院、浙江省第二医院","陈焰","中国","浙江省","杭州市"],["中国医科大学附属盛京医院（中国医科大学附属第二医院）","田丰","中国","辽宁省","沈阳市"],["中南大学湘雅三医院","王晓艳","中国","湖南省","长沙市"],["北京大学第三医院（北京大学第三临床医学院）","丁士刚","中国","北京市","北京市"],["天津医科大学总医院","王邦茂","中国","天津市","天津市"],["Epworth Eastern Hospital","Elizabeth Chow","澳大利亚","Victoria/Box Hill","Victoria/Box Hill"],["Mater Misericordiae Limited","Yoon-Kyo An","澳大利亚","Queensland/Brisbane","Queensland/Brisbane"],["Coral Sea Clinical Research Institute","James Daveson","澳大利亚","Queensland/North Mackay","Queensland/North Mackay"],["SA Group of Specialists – IBDSA","Peter Bampton","澳大利亚","South Australia/Kurralta Park","South Australia/Kurralta Park"],["Nepean Hospital","Martin Weltman","澳大利亚","New South Wales/Penrith","New South Wales/Penrith"],["UZ Leuven","Severine Vermeire","比利时","Flemish Brabant/Leuven","Flemish Brabant/Leuven"],["PreventaMed, s.r.o.","Jiri Pumprla","捷克共和国","Olomouc","Olomouc"],["Vojenska Nemocnice Brno","David Stepek","捷克共和国","Brno","Brno"],["Hepato-Gastroenterologie HK, s.r.o.","Miroslava Volfova","捷克共和国","Hradec Kralove","Hradec Kralove"],["Nemocnice Slany","Martin Peterka","捷克共和国","Slany","Slany"],["CHRU Montpellier - Saint Eloi","Romain Altwegg","法国","Montpellier","Montpellier"],["H？pital Rangueil","Laurent Alric","法国","Toulouse","Toulouse"],["CHU de Nice - L'Archet","Adrien Nicolau","法国","Nice","Nice"],["Universit？tsklinikum Ulm","Jochen Klaus","德国","Baden-Wurttemberg/Ulm","Baden-Wurttemberg/Ulm"],["Gastroenterologische Gemeinschaftspraxis Minden","Philipp Efken","德国","North Rhine-Westphalia/Minden","North Rhine-Westphalia/Minden"],["Universit？tsklinikum Jena","Andreas Stallmach","德国","Thuringia/Jena","Thuringia/Jena"],["Universitatsklinikum Schleswig-Holstein","Stefan Schreiber","德国","Schleswig-Holstein/Kiel","Schleswig-Holstein/Kiel"],["Iwate Medical University Uchimaru Medical Center","Takayuki Matsumoto","日本","Iwate/Morioka-shi","Iwate/Morioka-shi"],["Hyogo Medical University Hospital","Shinichiro Shinzaki","日本","Hyogo-Ken/Nishinomiya-shi","Hyogo-Ken/Nishinomiya-shi"],["Hamamatsu University Hospital","Ken Sugimoto","日本","Shizuoka/Hamamatsu-shi","Shizuoka/Hamamatsu-shi"],["Institute of Science Tokyo Hospital","Kento Takenaka","日本","Tokyo/Bunkyo-Ku","Tokyo/Bunkyo-Ku"],["Oita Red Cross Hospital","Tetsuya Ueo","日本","Oita/Oita-shi","Oita/Oita-shi"],["Matsuda Hospital","Katsuhiko Kawakami","日本","Shizuoka/Hamamatsu-shi","Shizuoka/Hamamatsu-shi"],["Tsujinaka Hospital-Kashiwanoha","Ken Takeuchi","日本","Chiba/Kashiwa-shi","Chiba/Kashiwa-shi"],["National Hospital Organization Hirosaki General Medical Center","Yoh Ishiguro","日本","Aomori-Ken/Hirosaki-Shi","Aomori-Ken/Hirosaki-Shi"],["Krakowskie Centrum Medyczne","Piotr Rozpondek","波兰","Lower Silesia/Krakow","Lower Silesia/Krakow"],["Vistamed & Vertigo Sp. z o.o.","Bernardeta Frysna","波兰","mazowieckie/Warszawa","mazowieckie/Warszawa"],["WIP Warsaw IBD Point","Jaroslaw Kierkus","波兰","mazowieckie/Warszawa","mazowieckie/Warszawa"],["FutureMeds Wroclaw","Karol Kowalski","波兰","Kuyavian-Pomerania/Wroclaw","Kuyavian-Pomerania/Wroclaw"],["Medrise Sp. z o.o.","Wit Cezary Danilkiewicz","波兰","lubelskie/Lublin","lubelskie/Lublin"],["Endoskopia Sp. z o. o.","Dariusz Kleczkowski","波兰","pomorskie/Sopot","pomorskie/Sopot"],["TrialMed - Piotrkow Trybunalski","Beata Neneman","波兰","lodzkie/Piotrkow Trybunalski","lodzkie/Piotrkow Trybunalski"],["Centrum Zdrowia Matki, Dziecka i M？odzie？y","Milosz Jastrzebski","波兰","mazowieckie/Warszawa","mazowieckie/Warszawa"],["Office of John P. Wright, MB CHB","John Wright","南非","Western Cape/Claremont","Western Cape/Claremont"],["Lenmed Ahmed Kathrada Private Hospital","Nazeer Chopdat","南非","Gauteng/Johannesburg","Gauteng/Johannesburg"],["Clinresco Centres","Jennifer Rosa","南非","Gauteng/Johannesburg","Gauteng/Johannesburg"],["Busamed Hillcrest Private Hospital","Ronelle Moodliar","南非","Durban","Durban"],["Mediclinic Constantiaberg","Naayil Rajabally","南非","Plumstead","Plumstead"],["Hospital Universitario La Paz","Maria Dolores Martin Arranz","西班牙","Madrid","Madrid"],["FutureMeds - Madrid Santa Elena","Laura Crespo","西班牙","Chamberí","Chamberí"],["Hospital Universitario Virgen Macarena","Federico Arugelles Arias","西班牙","Seville/Sevilla","Seville/Sevilla"],["Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital","Mark Samaan","英国","London","London"],["Elpida Sciences Clinical Trials","Balgit Chhokar","英国","London","London"],["Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital","Timothy Raine","英国","Cambridge","Cambridge"],["Barts Health NHS Trust - The Royal London Hospital","Syed Hoque","英国","London","London"],["Fairfield General Hospital","Jimmy Limdi","英国","Bury","Bury"],["Gastro Care Institute","Kumaravel Perumalsamy","美国","California/Lancaster","California/Lancaster"],["Gastroenterology Clinic of San Antonio, P.A. (GCSA) - Fredericksburg","Charles Randall","美国","Texas/Fredericksburg","Texas/Fredericksburg"],["University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne - UNC Endocrinology","Millie Long","美国","North Carolina/Escondido","North Carolina/Escondido"],["Gastroenterology & Liver Institute","Naveen Gara","美国","California/Escondido","California/Escondido"],["University of Kansas Medical Center (KUMC)","Tuba Esfandyari","美国","Kansas/Kansas City","Kansas/Kansas City"],["AdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando","Ilan Aharoni","美国","Florida/Orlando","Florida/Orlando"],["Gastroenterology Associates of Western Michigan","Allan Coates","美国","Michigan/Wyoming","Michigan/Wyoming"],["Jackson Siegelbaum Gastroenterology - East Shore","Adnan Ahmad","美国","Pennsylvania/Harrisburg","Pennsylvania/Harrisburg"],["Baylor College of Medicine Medical Center - McNair Campus","Jason Hou","美国","Texas/Houston","Texas/Houston"],["Tropical Clinical Trials","Michael Feldman","美国","Florida/Palmetto Bay","Florida/Palmetto Bay"],["Sylvester Comprehensive Cancer Center","David Kerman","美国","Florida/Miami","Florida/Miami"],["Washington University School of Medicine - Center for Advanced Medicine - Gastroenterology Center","Deepak Parakkal","美国","Missouri/Saint Louis","Missouri/Saint Louis"],["Alliance Medical Research - Lighthouse Point","Vipin Gupta","美国","Florida/Lighthouse Point","Florida/Lighthouse Point"],["Advanced Research Institute","John Lowe","美国","Utah/Ogden","Utah/Ogden"],["Central Florida Gastro Research","Asif Mohiuddin","美国","Florida/Kissimmee","Florida/Kissimmee"],["Gastrointestinal Specialists of Georgia, PC","Aasim Sheikh","美国","Georgia/Marietta","Georgia/Marietta"],["Brigham and Women's Hospital","Jessica Allegretti","美国","Massachusetts/Boston","Massachusetts/Boston"],["University of Washington Medical Center","Scott Lee","美国","NM/Las Cruces","NM/Las Cruces"],["Banner-University Medical Center Tucson Campus","Sasha Taleban","美国","Arizona","Arizona"],["University of Iowa Hospitals and Clinics","Steven Polyak","美国","Iowa/Iowa City","Iowa/Iowa City"],["Gulf Coast Gastroenterology LLC","Nathaniel Winstead","美国","AL/Fairhope","AL/Fairhope"],["VCU Medical Center","William Pandak","美国","Virginia/Richmond","Virginia/Richmond"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中山大学附属第六医院伦理委员会","同意","2025-05-23"]]

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: 9 ； 国际: 登记人暂未填写该信息；
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；