北京Itepekimab注射液III期临床试验-一项在控制不佳的慢性鼻窦炎伴鼻息肉参与者中评估 itepekimab （抗 IL-33 mAb）的疗效、安全性和耐受性的 Ⅲ 期研究

登记号	CTR20250539	试验状态	进行中
申请人联系人	赛诺菲	首次公示信息日期	2025-02-18
申请人名称	Sanofi-Aventis Recherche & Développement/ 赛诺菲（中国）投资有限公司/ Genzyme Ireland Limited

登记号	CTR20250539
相关登记号	暂无
药物名称	Itepekimab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	慢性鼻窦炎伴鼻息肉
试验专业题目	一项在控制不佳的慢性鼻窦炎伴鼻息肉成人参与者中评价 itepekimab 的疗效、安全性和耐受性的随机、双盲、安慰剂对照、平行组、52 周 Ⅲ 期试验
试验通俗题目	一项在控制不佳的慢性鼻窦炎伴鼻息肉参与者中评估 itepekimab （抗 IL-33 mAb）的疗效、安全性和耐受性的 Ⅲ 期研究
试验方案编号	EFC18419	方案最新版本号	临床试验方案01
版本日期:	2024-10-14	方案是否为联合用药	否

申请人名称	[["Sanofi-Aventis Recherche & Développement"],["赛诺菲（中国）投资有限公司"],["Genzyme Ireland Limited"]]
联系人姓名	赛诺菲	联系人座机	010-65634716	联系人手机号
联系人Email	contact-us.cn@sanofi.com	联系人邮政地址	北京市-北京市-朝阳区建国路112号	联系人邮编	100022

主要目的：评价 itepekimab 与安慰剂相比对 NP 大小和鼻塞的疗效。 次要目的：评价 itepekimab 与安慰剂相比对 NP 大小的长期疗效；评价 itepekimab 与安慰剂相比对鼻塞的长期疗效；评价 itepekimab 与安慰剂相比对鼻窦浑浊的疗效；评价 itepekimab 与安慰剂相比对 CRSwNP 症状的疗效；评价 itepekimab 与安慰剂相比对嗅觉的疗效；评价 itepekimab 与安慰剂相比在健康相关生活质量方面的疗效；评价 itepekimab 与安慰剂相比对睡眠失调的疗效；评价 itepekimab 与安慰剂相比降低需要 SCS 或鼻窦手术治疗的加重／急性鼻窦 炎风险的能力；评价 itepekimab 与安慰剂相比对合并哮喘的参与者的哮喘的作用；评价 itepekimab 与安慰剂相比对 AERD 参与者亚组的作用；评价 itepekimab 与安慰剂相比的疗效；评价 itepekimab 与安慰剂相比在 CRSwNP 参与者中的安全性和耐受性；评价 itepekimab 的 PK；评估与安慰剂相比 itepekimab 的经时免疫原性。

试验分类	安全性和有效性	试验分期	III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	[["参与者在签署知情同意时必须年满 18 岁。"],["参与者在筛选前有至少 1 年 CRSwNP 病史"],["参与者必须至少有以下特征之一：n- 既往接受过 NP 鼻腔鼻窦手术。 n- 筛选访视（访视 1）前 2 年 CRS 症状加重并需要 SCS 治疗。 n- 过去 2 年 CRS 症状加重，需要 SCS 治疗，但参与者对 SCS 不耐受或禁忌使用 SCS。"],["在筛选和随机化时，内镜双侧 NPS 至少为 5（最高评分为 8；每侧鼻腔的最低评分 为 2）。"],["持续存在以下症状（访视 1 前已持续存在至少 12 周）：n1.t访视 1 时存在中度或重度鼻塞／鼻堵（症状严重程度评分为 2 或 3）并且随机化 （访视 2）前一周的平均严重程度评分高于 1， n且 n2. 至少出现以下两种症状之一：嗅觉丧失或流涕（前流涕／后流涕）。"],["女性参与者如未处于妊娠期或哺乳期且符合以下至少一个条件，则有资格参加研究：n-t不是 WOCBP 或 n-t是 WOCBP 并且同意在研究期间（至少直至研究干预末次给药后 20 周） 采用失败率＜1% 的高效避孕方法。"]]
排除标准	[["研究者认为参与者有可能干扰研究或需要接受可能干扰研究的治疗的具有临床意义的肾脏、肝脏、代谢系统、神经系统、血液学、眼科、呼吸系统（不包括可能纳入 本研究的哮喘和 AERD 参与者）、胃肠系统、心血管、脑血管或其他重大疾病或功 能障碍病史。"],["目前正在吸烟和／或吸电子烟的参与者，或在筛选（访视 1）前 6 个月内戒烟的参与者。尼古丁替代疗法和／或非吸入性烟草制品的使用不视为当前吸烟。"],["参与者有 MFNS 的任何禁忌症，例如对 MFNS 或其任何组分过敏，或存在未控制的机会性感染的参与者。"],["有对 mAb 存在重度全身性超敏反应病史的参与者。"],["参与者的疾病／合并症使其在访视 1 时无法评估或无法进行主要疗效终点评价。"],["参与者存在鼻腔恶性肿瘤和良性肿瘤（例如，乳头状瘤、血肿等）。"],["过去一年内有 2 次和／或以上需要 SCS 治疗的急性加重史或 1 次需要 SCS 的住院治疗的重度未控制哮喘参与者。"],["研究者认为可能干扰肺功能测定的表现和解读的合并肺疾病史（哮喘除外，例如，COPD、间质性肺疾病）。"],["筛选期间接受 INCS（允许使用 MFNS）、鼻内给药器械／支架、使用呼气式给药系统的鼻喷雾剂（例如 Xhance™）治疗的参与者。在日本和中国，允许使用除 MFNS 以外的 INCS。"],["访视 1 前 6 个月内接受过任何鼻窦鼻内手术（包括息肉切除术）的参与者。"],["在筛选访视（访视 1）前 1 个月或在筛选期间（访视 1 和访视 2 之间）接受 SCS 治疗的参与者。"],["已知对 itepekimab 或其辅料或研究者认为禁忌参加本研究的任何药物过敏，或其他过敏。"]]

试验药	[["中文通用名:SAR440340 英文通用名:itepekimab 商品名称:NA","剂型:注射液 规格:此信息暂不披露 用法用量:单剂量,皮下注射给药。 用药时程:52周"]] 序号 名称 用法
对照药	[["中文通用名:与itepekimab匹配的安慰剂 英文通用名:NA 商品名称:NA","剂型:注射液 规格:无 用法用量:单剂量,皮下注射给药。 用药时程:52周"]] 序号 名称 用法

主要终点指标及评价时间

[["内镜 NPS 较基线的变化。","基线至24周","有效性指标"],["NCS 较基线的变化","基线至24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

[["内镜 NPS 较基线的变化","基线至52周","有效性指标"],["NCS 较基线的变化","基线至52周","有效性指标"],["使用 LMK 评分根据 CT 扫描评估的 鼻窦浑浊较基线的变化。","基线至24周","有效性指标"],["TSS（鼻塞／鼻堵、前流 涕／后流涕和嗅觉丧失）较基线的变化。","基线至24周，52周","有效性指标"],["使用每日 CRSwNP 鼻腔鼻窦症状电子日志评 估的嗅觉丧失严重程度评分和 UPSIT 评分。","基线至24周，52周","有效性指标"],["SNOT-22 总分较基线的变化。","基线至24周，52周","有效性指标"],["PROMIS SD-SF-8b 评分较基线的变化。","基线至24周，52周","有效性指标"],["需要使用 SCS 或手术治疗的 CRSwNP 参与者比例。","基线至52周","有效性指标"],["在计划的研究干预期间，使用 SCSa 或手术治 疗 CRS 的年化发生率。","基线至52周","有效性指标"],["至首次使用 SCS 或手术治疗 CRS 的时间。","基线至52周","有效性指标"],["在合并哮喘的参与者中，pre-BD FEV1（单位 mL）较基线的变化。","基线至24周， 52周","有效性指标"],["在合并哮喘的参与者中，ACQ-5评分较基线的变化。","基线至24周， 52周","有效性指标"],["在 AERD 参与者亚组中，NPS 和 NCS 较基线的变化。","基线至24周， 52周","有效性指标"],["在计划的研究干预期间，需要使用 SCS 或手术 治疗 CRS 的 AERD 参与者比例。","基线至52周","有效性指标"],["在计划的研究干预期间，AERD 参与者中使用 SCS 或手术治疗 CRS 的年化发生率。","基线至52周","有效性指标"],["至 AERD 参与者首次使用 SCS 或手术治疗 CRS 的时间。","基线至52周","有效性指标"],["在 AERD 参与者中，preBD FEV1（单位 mL）较基线的变化。","基线至24周， 52周","有效性指标"],["NPS 应答者比例（定义为 NPS 改善至少 1 分的参与者）。","第 24 周和第 52 周","有效性指标"],["NPS 应答者比例（定义为 NPS 改善至少 2 分的参与者）。","第 24 周和第 52 周","有效性指标"],["TEAE、TESAE、TEAESI 和导致治疗终止的 TEAE 的发生率。","基线至第72周试验结束","安全性指标"],["Itepekimab 的血清浓度。","基线至第72周试验结束","有效性指标+安全性指标"],["整个研究期间治疗期间出现的抗 itepekimab 抗体（ADA）反应的发生率。","基线至第72周试验结束","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	张罗	学位	医学博士	职称	主任医师
	电话	13911189954	Email	dr.luozhang@gmail.com	邮政地址	北京市-北京市-东交民巷1号
	邮编	100005	单位名称	首都医科大学附属北京同仁医院

[["首都医科大学附属北京同仁医院","张罗","中国","北京市","北京市"],["首都医科大学附属北京同仁医院","王成硕","中国","北京市","北京市"],["山东省第二人民医院（山东省耳鼻喉医院）","史丽","中国","山东省","济南市"],["烟台毓璜顶医院","宋西成","中国","山东省","烟台市"],["成都市第二人民医院","何刚","中国","四川省","成都市"],["安徽省立医院","孙敬武","中国","安徽省","合肥市"],["中国医科大学附属盛京医院","曹志伟","中国","辽宁省","沈阳市"],["淄博市中心医院","宋道亮","中国","山东省","淄博市"],["荆州市中心医院","万俐佳","中国","湖北省","荆州市"],["武汉大学人民医院","许昱","中国","湖北省","武汉市"],["山西医科大学第一医院","柴向斌","中国","山西省","太原市"],["浙江大学医学院附属第一医院","周水洪","中国","浙江省","杭州市"],["包头市中心医院","许振东","中国","内蒙古自治区","包头市"],["广西壮族自治区人民医院","瞿申红","中国","广西壮族自治区","南宁市"],["山西医科大学第二医院","薛金梅","中国","山西省","太原市"],["苏州大学附属第一医院","于亚峰","中国","江苏省","苏州市"],["CARE - Centro de Alergia y Enfermedades Respiratorias","Melina HEINZE","ARGENTINA","Buenos Aires","Buenos Aires"],["Fundación CIDEA","Jorge Máspero","ARGENTINA","Buenos Aires","Buenos Aires"],["Fundación Scherbovsky","Pablo Saez Scherbovsky","ARGENTINA","Mendoza","Mendoza"],["Instituto de Asma, Alergia y Enfermedades Respiratorias","Alejandro Berardi","ARGENTINA","CORRIENTES","CORRIENTES"],["Investigaciones en Patologias Respiratorias","AnatStok","ARGENTINA","SAN MIGUEL DE TUCUMáN","SAN MIGUEL DE TUCUMáN"],["TrialsWest - Spearwood","Chady Sader","AUSTRALIA","South Australia","Eastwood"],["Royal Brisbane and Women's Hospital","Abigail WALKER","AUSTRALIA","Queensland","Herston"],["UZ Leuven","Peter Hellings","BELGIUM","Leuven","Leuven"],["Universitair Ziekenhuis Gent","PHILIPPEtGevaert","BELGIUM","Gent","Gent"],["Cliniques Universitaires Saint Luc","Valerie Marie Hox","BELGIUM","Brussels","Brussels"],["Pneumocare","Jean-Benoit Martinot","BELGIUM","Gesves Namur","Gesves Namur"],["UZ Brussel","Sébastien Carlot","BELGIUM","Jette","Jette"],["Anima research center","Hilde Bollen","BELGIUM","Alken","Alken"],["Nelson Rosario Medicos Associados S/S","Nelson Augusto Rosário Filho","BRAZIL","Paraná","Curitiba"],["Faculdade de Medicina de Marilia","Vanessa Dinarte","BRAZIL","Marília","Marília"],["Clinica de Alergia Martti Antila","Martti ANTILA","BRAZIL","Sorocaba","Sao Paulo"],["CLIGED - Unidade Barra da Tijuca","Susan Tabasnik","BRAZIL","Rio De Janeiro","Rio De Janeiro"],["Institut universitaire de cardiologie et de pneumologie de Quebec","Michel Bussieres","CANADA","Quebec","Quebec"],["McGill University Health Centre - Glen Site","Marc Tewfik","CANADA","Quebec","Montreal"],["Centre De Recherche Appliqué En Allergie De Québec","Remi Gagnon","CANADA","Quebec","Quebec"],["Dartmouth ENT Associates","John Scott","CANADA","Nova Scotia","Dartmouth"],["St. Joseph's Health Care","Leigh Sowerby","CANADA","Ontario","Toronto"],["BV Medical Research","Nikhil Pradip Joshi","CANADA","Alberta","Calgary"],["CIC Mauricie","Bruno Francoeur","CANADA","Trois-Rivières","Trois-Rivières"],["Inspiration Research","Kenneth Chapman","CANADA","Ontario","Toronto"],["Alpha Recherche Clinique - Lebourgneuf Clinic","Steeve Kwan Tat","CANADA","Quebec","Levis"],["Triple A Lab","Jason Ohayon","CANADA","Hamilton","Hamilton"],["Yang Medicine","Shaun Kilty","CANADA","Ottawa","Ottawa"],["Dr. Smriti Nayan Medicine Professional Corp","Smriti Nayan","CANADA","Ontario","Cambridge"],["Fakultní nemocnice v Motole","Stepan NOVAK","CZECHIA","Praha 5","Praha 5"],["Fakultni nemocnice Hradec Kralove","Viktor Chrobok","CZECHIA","Hradec Kralove","Hradec Kralove"],["Nemocnice Pardubického kraje","Zdenek Knizek","CZECHIA","Pardubice","Pardubice"],["Fakultní nemocnice Královské Vinohrady","PetrtSchalek","CZECHIA","Praha 10","Praha 10"],["Fakultni nemocnice Plzen","Vladan Hrabe","CZECHIA","Plzen - Bory","Plzen - Bory"],["Aarhus Universitetshospital - Skejby","Tejs Ehlers-Klug","DENMARK","Aarhus","Aarhus"],["Sjaellands Universitetshospital/Zealand University Hospital","Preben Homoe","DENMARK","Koge","Koge"],["Hvidovre Hospital","Charlotte Suppli Ulrik","DENMARK","Hvidovre","Hvidovre"],["Hopital de la Conception","Thomas RADULESCO","FRANCE","MARSEILLE","MARSEILLE"],["Hopital Gui de Chauliac","Valentin Favier","FRANCE","Montpellier","Montpellier"],["Centre Hospitalier Universitaire de Poitiers","Florent Carsuzaa","FRANCE","Poitiers","Poitiers"],["Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin Tripode","Ludovic De Gabory","FRANCE","BORDEAUX","BORDEAUX"],["HApital NOVO a€“ site de Pontoise","Benoit Faucon","FRANCE","PONTOISE","PONTOISE"],["Technische Universitaet Dresden","Philipp Nahrath","GERMANY","Dresden","Dresden"],["Universitatsklinikum Leipzig","Andreas DIETZ","GERMANY","Leipzig","Leipzig"],["SRH Wald-Klinikum Gera","Andreas Müller","GERMANY","GERA","GERA"],["Universitaetsklinikum Duesseldorf","Martin Wagenmann","GERMANY","Düsseldorf","Düsseldorf"],["Universitatsklinikum Hamburg-Eppendorf","Anna-Sophie Hoffmann","GERMANY","Hamburg","Hamburg"],["Szegedi Tudományegyetem","Agnes Kiricsi","HUNGARY","Szeged","Szeged"],["RMC Medical Zrt.","László Balogh","HUNGARY","Budapest","Budapest"],["Galilee Medical Center","TAL MARSHAK","ISRAEL","Nahariya","Nahariya"],["Kaplan Medical Center","MeirtWarman","ISRAEL","Rehovot","Rehovot"],["Bnai Zion Medical Center","Shihada Rabia","ISRAEL","Haifa","Haifa"],["Hadassah Medical Center","Ron Eliashar","ISRAEL","Jerusalem","Jerusalem"],["San Raffaele Hospital","Giulia Dane","ITALY","Milano","Milano"],["Presidio Ospedaliero Vittorio Emanuele","Ignazio La Mantia","ITALY","Catania","Catania"],["Azienda Ospedaliero Universitaria di Ferrara","Stefano Pelucchi","ITALY","FERRARA","FERRARA"],["Azienda Ospedaliera Universitaria Federico II","Elena Cantone","ITALY","Naples","Naples"],["Instituto Jalisciense de Investiacion Clinica","dante hernandez colin","MEXICO","Jalisco","Guadalajara"],["Arke SMO SA de CV","AlejandratOrtega Salazar","MEXICO","Veracruz","Veracruz"],["Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia","AnatLeon-de-Avila","MEXICO","Durango","Durango"],["ICARO Investigaciones en Medicina","Victor ManueltBelalcazar Lopez","MEXICO","Chihuahua","Chihuahua"],["Oaxaca Site Management Organization","Lorenzo Tobias Avendano Santiago","MEXICO","Oaxaca","Oaxaca"],["Centro de Investigación Médica Aguascalientes (CIMA)","Erika Nayeli Duron Lopez","MEXICO","Aguascalientes","Aguascalientes"],["Hospital Angeles Chihuahua","GerardotMejia Jaramillo","MEXICO","Chihuahua","Chihuahua"],["Eukarya PharmaSite","LINO ANTONIO GUEVARA MALDONADO","MEXICO","Monterrey","Monterrey"],["Universitair Medisch Centrum Utrecht","Digna Kamalski","NETHERLANDS","UTRECHT","UTRECHT"],["Amsterdam UMC, locatie AMC","Sietze Reitsma","NETHERLANDS","Amsterdam","Amsterdam"],["Szpital Sw. Lukasza","Sarka Solecka","POLAND","Bielsko-Biala","Bielsko-Biala"],["Santa Sp. z o.o.","Magdalena Jozefowicz-Korczynska","POLAND","Lodz","Lodz"],["IP Clinic","Tomasz Grzelewski","POLAND","Lodz","Lodz"],["Fundeni Clinical Institute","Mihaela Mitroi","ROMANIA","Bucharest","Bucharest"],["Centrul Medical de Diagnostic si Tratament Ambulator","Valeriu Bronescu","ROMANIA","brasov","brasov"],["Centrul Medical Unirea SRL Brasov","Catalin Stefan","ROMANIA","brasov","brasov"],["Hospital Universitario Marqués de Valdecilla","David Robinson Lobo Duro","SPAIN","Cantabria","Santander"],["Hospital Universitari de Bellvitge","Xavier Gonzalez-Compta","SPAIN","BARCELONA","BARCELONA"],["Hospital Del Mar","Rafael Hijano Esque","SPAIN","Barcelona","Barcelona"],["Clinica Universidad de Navarra - Pamplona","Secundino Gonzalez","SPAIN","Navarra","PAMPLONA"],["Hospital Universitario Ramón y Cajal","ALFONSO Santamaria Gadea","SPAIN","Madrid","Madrid"],["Hospital Universitario Fundacion Jimenez Diaz","Jose-Miguel VILLACAMPA","SPAIN","Madrid","Madrid"],["Bursa Uludag Universitesi Kulak burun Bogaz","UYGAR DEMIR","TüRKIYE","Bursa","Bursa"],["Sisli Etfal Egitim ve Arastima Hastanesi","BILGE TURK","TüRKIYE","Istanbul","Istanbul"],["Ankara Tip Ibni Sina Hastanesi","Suha Beton","TüRKIYE","Ankara","Ankara"],["Imperial College Healthcare NHS Trust","Catherine Rennie","UNITED KINGDOM","London","London"],["Wrightington Hospital","Balasubrahmanyam Nirmal Kumar","UNITED KINGDOM","Wigan","Wigan"],["Musgrove Park Hospital","Edward Chisholm","UNITED KINGDOM","Taunton","Taunton"],["NHS Greater Glasgow and Clyde - Queen Elizabeth University Hospital","Saleh Okhovat","UNITED KINGDOM","Glasgow","Glasgow"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["首都医科大学附属北京同仁医院伦理委员会","同意","2024-12-10"]]

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: 33 ； 国际: 210 ；
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；