北京GalvokimigII期临床试验-一项在慢性阻塞性肺疾病伴慢性支气管炎研究参与者中评价galvokimig的有效性和安全性的II期、双盲、安慰剂对照、随机研究（SCALA）

登记号	CTR20262955	试验状态	进行中
申请人联系人	陈晶晶	首次公示信息日期	2026-07-30
申请人名称	UCB Biopharma SRL/ 优时比贸易（上海）有限公司/ Vetter Development Services USA Inc.

登记号	CTR20262955
相关登记号	暂无
药物名称	Galvokimig
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	慢性阻塞性肺疾病伴慢性支气管炎
试验专业题目	一项在中重度慢性阻塞性肺疾病伴慢性支气管炎研究参与者中评价galvokimig有效性和安全性的为期24-52周治疗的II期、多中心、随机、双盲、安慰剂对照研究（SCALA）
试验通俗题目	一项在慢性阻塞性肺疾病伴慢性支气管炎研究参与者中评价galvokimig的有效性和安全性的II期、双盲、安慰剂对照、随机研究（SCALA）
试验方案编号	COPD01	方案最新版本号	修订案2
版本日期:	2026-05-12	方案是否为联合用药	否

申请人名称	[["UCB Biopharma SRL"],["优时比贸易（上海）有限公司"],["Vetter Development Services USA Inc."]]
联系人姓名	陈晶晶	联系人座机	021-23210288	联系人手机号	13916411574
联系人Email	Emma.Chen@ucb.com	联系人邮政地址	上海市-上海市-黄浦区西藏中路268号上海来福士广场办公楼4906室	联系人邮编	200001

探讨在中重度COPD伴慢性支气管炎研究参与者中评价galvokimig与安慰剂相比在至首次慢性阻塞性肺疾病急性加重（AECOPD）时间方面的有效性。

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	40岁(最小年龄)至 80岁(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（ICF）时，参与者的年龄必须≥40岁且≤80岁（含）。"],["参与者经医生确诊为伴慢性支气管炎的中重度COPD。"],["有记录证实参与者在筛选前接受过稳定剂量维持吸入治疗≥3个月，治疗方案包括：n-长效β2受体激动剂（LABA）+ 长效抗胆碱能药物（LAMA）± 吸入糖皮质激素（ICS）"],["急性加重高危参与者，定义为：在筛选前12个月内记录有≥2次中度或重度AECOPD急性加重病史，或在筛选前6个月内记录有1次重度AECOPD急性加重病史。"],["筛选时参与者的CAAT 评分≥15。"],["在筛选访视期间，根据美国胸科学会/欧洲呼吸学会（ATS/ERS）指南，参与者需掌握可接受的吸入器给药和肺活量测定技术。"],["参与者可以是男性，也可以是女性。n- 男性参与者必须同意在干预期间和研究干预末次给药后至少60天内采取措施进行避孕，并且在这个研究期中禁止捐精。n- 非妊娠、非哺乳期且至少符合以下一项条件的女性研究参与者可参加本研究：n○ 非有生育能力的女性（WOCBP）或n○ 同意在干预期间以及研究干预末次给药后至少60 天内遵循避孕指南的WOCBP。"],["参与者为当前吸烟者或已戒烟者（吸烟史≥10 包/年）。"]]
排除标准	[["参与者既往或当前患有任何医学或精神疾病，经研究者判定，体格检查结果、实验室检查结果或心电图（ECG）信号在参与者接受研究干预治疗时可能带来风险；或干扰数据解读，可能危害或损害研究参与者参加本研究的能力。"],["在筛选前12 个月内，参与者有失代偿性心脏衰竭、体液过多或心肌梗死病史，或有新发缺血性心脏病或研究者判定的其他严重心脏疾病证据。"],["参与者存在IBD（包括克罗恩病和溃疡性结肠炎）或有IBD 家族史（一级亲属）。"],["参与者有未受控制的神经精神疾病、主动自杀意念或明确的自杀行为。"],["参与者在基线前6个月内存在慢性或复发性具有临床意义的感染或严重肺外感染史。"],["参与者患有除COPD伴慢性支气管炎以外的具有临床意义的肺疾病。"],["参与者患有需要双水平正压通气（BiPAP）的高碳酸血症。"],["参与者在筛选前4周内接种过活疫苗或减毒疫苗，或计划在研究期间接种此类疫苗。"],["参与者发生过一种或多种IL-13或IL-17生物反应调节剂相关安全性事件，导致治疗终止和方案改变。"],["参与者的中性粒细胞绝对计数（ANC）<1.5×10^3/μL。"],["男性参与者的校正的QT间期（QTc）>450 ms，或女性参与者的QTc>470 ms，或束支阻滞参与者的QTc>480 ms。"],["参与者在过去12个月内有长期酒精或药物滥用既往史或现病史。"]]

试验药	[["中文通用名:Galvokimig 英文通用名:Galvokimig 商品名称:NA","剂型:/ 规格:/ 用法用量:/ 用药时程:/"]] 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:/ 规格:/ 用法用量:/ 用药时程:/"]] 序号 名称 用法

主要终点指标及评价时间	[["从治疗分配至首次发生中度或重度AECOPD 的时间","直至60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	[["24周时支气管扩张剂（BD）给药前的第1秒用力呼气容积（FEV1）","第24周","有效性指标"],["截至治疗结束时的中重度AECOPD年发生率","从基线至52周","有效性指标"],["第24周时SGRQ-C较基线的变化","第24周","有效性指标"],["从基线至第24周SGRQ-C总评分降低≥4分的参与者比例","从基线至24周","有效性指标"],["TEAE的发生率","从基线至60周","安全性指标"],["严重TEAE的发生率","从基线至60周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	黄可	学位	医学博士	职称	副高级
	电话	15120079197	Email	huangke_zryy@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","黄可","中国","北京市","北京市"],["江西省人民医院 /南昌医学院第一附属医院","肖祖克","中国","江西省","南昌市"],["浙江省人民医院","孙益兰","中国","浙江省","杭州市"],["成都市第五人民医院","刘晓","中国","四川省","成都市"],["浙江大学医学院附属第二医院","黄华琼","中国","浙江省","杭州市"],["广州市第一人民医院","赵祝香","中国","广东省","广州市"],["广东医科大学附属医院","吴斌","中国","广东省","湛江市"],["深圳市人民医院","王凌伟","中国","广东省","深圳市"],["上海浦东新区人民医院","顾文超","中国","上海市","上海市"],["河北医科大学第三医院","赵云霞","中国","河北省","石家庄市"],["扬州市第一人民医院","吴峰","中国","江苏省","扬州市"],["Katholieke Universiteit Leuven, U Hospitals UZ Gasthuisberg","Wim Janssens","比利时","Flemish Region","Leuven"],["Antwerp University Hospital - Pneumologie","Thérèse Lapperre","比利时","Antwerpen","Edegem"],["Hopital Erasme","sylvia perez-bogerd","比利时","Brussels Capital Region","brussel"],["CHU De Liège - Pneumologie - Allergologie","Renaud Louis","比利时","Liège","Liège"],["Algemeen Ziekenhuis (AZ) Sint-Maarten","Muriel Lins","比利时","Antwerpen","Mechelen"],["Medical Center Pulmo-2018 EOOD","Veselin Kalfov","保加利亚","Haskovo","Haskovo"],["Medical Center Excelsior OOD, Base 1","Todor Popov","保加利亚","Sofia-Grad","Sofia"],["Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD","Stela Stefanova","保加利亚","Sofia","Sofia"],["Medical Center Zdrave-1 EOOD","Rumen Tiholov","保加利亚","Vratsa","Kozloduy"],["Medical Center Hermes Ruse Ltd","Nikolay Nikolaev","保加利亚","Ruse","Ruse"],["Multi-Profile Hospital for Active Treatment (MHAT) ''Dr. Stamen Iliev'' JSC - Montana","Lidiya Nikolcheva-Todorova","保加利亚","Montana","Montana"],["Diagnostics And Consultation Center Convex Ltd.","Kosta Kostov","保加利亚","Sofia-Grad","Sofia"],["Medical Center Hera - Pulmonology Office","Kiril Palaveev","保加利亚","Sofia","Sofia"],["Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD","Hristo Metev","保加利亚","Ruse","Ruse"],["DCC-1 Sliven Ltd.","Dina Doseva","保加利亚","Sliven","Sliven"],["Multiprofile Hospital for Active Treatment","Atanas Parev","保加利亚","Plovdiv","Plovdiv"],["MEDICON a.s. - Plicni oddeleni","Vaclava Bartu","捷克共和国","Hlavni mesto Praha","Praha 4"],["Krajska nemocnice Liberec, a.s. - Oddeleni TBC a resp. nemoci","Tomas Vencalek","捷克共和国","Liberecky kraj","Liberec"],["Plicni ambulance Kralupy s.r.o.","Otakar Hokynar","捷克共和国","Mělník","Kralupy nad Vltavou"],["Pneumologie Varnsdorf s.r.o.","Milan Sklenar","捷克共和国","ústecky kraj","Varnsdorf"],["Plicni ordinace a kalmetizace","Marie Buresova","捷克共和国","Kraj Vysocina","Havlí？k？v Brod"],["MUDr. Pavlisova Ilona s.r.o.","Ilona Pavlisova","捷克共和国","Jihomoravsky kraj","Miroslav"],["H？pital Cochin","Nicolas Roche","法国","Paris","Paris"],["CHU de Nice - H？′pital Pasteur","Jacques Boutros","法国","Alpes-Maritimes","Nice"],["CHU de Nice - H？′pital Pasteur","Charles-Hugo Marquette","法国","Alpes-Maritimes","Nice"],["CHU Grenoble Alpes - Pulmonology","Bruno Degano","法国","Isère","La Tronche cedex 9"],["CHU Arnaud de Villeneuve - Maladies respiratoires","Arnaud BOURDIN","法国","Hérault","Montpellier Cedex 5"],["IKF Pneumologie Mainz - Helix Medical Excellence Center Mainz","Stephanie Korn","德国","Rheinland-Pfalz","Mainz"],["IKF Pneumologie - Pulmonology","Marc Oliver Kornmann","德国","Hessen","Frankfurt"],["POIS Sachsen","Juliana Brode","德国","Sachsen","Leipzig"],["Pneumologie Odeonsplatz","Jan Feimer","德国","Bayern","Muenchen"],["Studienzentrum Dr. Keller","Claus Keller","德国","Hessen","Frankfurt am Main"],["Lungenpraxis Hohenzollerndamm","Anneliese Linnhoff","德国","Berlin","Berlin"],["Ospedale Luigi Sacco - Pneumologia Sacco","Pierachille Santus","意大利","Milano","Milano"],["Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Pneumologia","Nicola Scichilone","意大利","Palermo","Palermo"],["(IRCCS AOM – Ospedale Policlinico San Martino - Clinica Malattie respiratorie e Allergologia","Fulvio Braido","意大利","Genova","Genova"],["IRCCS San Raffaele Roma S.r.l. - Clinical Trial Center","Franco Pasqua","意大利","Roma","Roma"],["Azienda Ospedaliero Universitaria Careggi - Pneumologia e fisiopatologia toracopolmonare","Federico Lavorini","意大利","Firenze","Firenze"],["ASST Ospedale Papa Giovanni XXIII - Pneumologia","Fabiano Di Marco","意大利","Bergamo","Bergamo"],["Centro Ricerche Cliniche Di Verona S.r.l. - Pneumologia","Claudio Micheletto","意大利","Verona","Verona"],["Arcispedale Sant'Anna, AOU di Ferrara - Pneumologia Territoriale","Alberto Papi","意大利","Ferrara","Ferrara"],["Kanazawa Medical Center - Respiratory Medicine","Toshiyuki 俊之 Kita 北","日本","Ishikawa","Kanazawa-shi"],["Fukuoka University Hospital - Respiratory Medicine","Masaki 昌樹 Fujita 藤田","日本","Fukuoka","Fukuoka-shi"],["Toho University Ohashi Medical Center","Hiroto 厚人 Matsuse 松瀬","日本","Tokyo","Meguro-ku"],["Gifu Prefectural General Medical Center - Respiratory Medicine","Fumihiro 文祐 Asano 浅野","日本","Gifu","Gifu-shi"],["Catharina Ziekenhuis - Pulmonology","Pascal Wielders","荷兰","Noord-Brabant","Eindhoven"],["EB FlevoResearch B.V.","Mazin AlHakim","荷兰","Flevoland","Almere"],["Gelre Hospitals - Pulmonology","Martijn Goosens","荷兰","Gelderland","Zutphen"],["Zuyderland Medisch Centrum - Pulmonology","Frank Custers","荷兰","Limburg","Heerlen"],["Centrum Medyczne Pratia Katowice","Szymon P？aczek","波兰","Slaskie","Katowice"],["Centrum Medycyny Oddechowej, Mroz Spolka Jawna","Robert Mroz","波兰","Podlaskie","Bialystok"],["Instytut Gruzlicy i Chorob Pluc - II Klinika Chorob Pluc","Pawel Sliwinski","波兰","Mazowieckie","Warszawa"],["Pratia MCM Krakow","Marek Koprowski","波兰","Mazowieckie","Krakow"],["Centrum Innowacyjnych Terapii","Luiza Jonczak","波兰","Mazowieckie","Warszawa"],["Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie","Lucyna Dymek","波兰","Opolskie","Strzelce Opolskie"],["Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna","Izabella Krupa-Borek","波兰","Lubelskie","Lublin"],["Centrum Medyczne ALL-MED","Grazyna Pulka","波兰","Malopolskie","Krakow"],["Pro Familia Altera Sp. z o. o.","Danuta Wronska","波兰","Warminsko-mazurskie","Katowice"],["Centrum Medyczne PROMED","Bozena Zurowicz","波兰","Mazowieckie","Krakow"],["Plucna ambulancia Hrebenar s.r.o.","Slavomir Hrebenar","斯洛伐克","Ko？icky kraj","Spisska Nova Ves"],["ZAPA JJ s.r.o. - Pneumologia a ftizeologia","Jan Plutinsky","斯洛伐克","Nitriansky kraj","Levice"],["NsP Sv. Jakuba, n.o., Bardejov - Odd. TBC a plucnych chorob","Helena Lescisinova","斯洛伐克","Pre？ovsky kraj","Bardejov"],["FNsP F.D.R. Banska Bystrica - Pneumologie a ftizeologie","Eva Beresova","斯洛伐克","Trenciansky Kraj","Banska Bystrica"],["MEDEKA s.r.o. - Pneumologia a ftizeologia","Erika Pribulova","斯洛伐克","Ko？icky Kraj","Kosice"],["Pectus Respiratory Health","Juan Roldan Sanchez","西班牙","Barcelona","Barcelona"],["Pectus Respiratory Health SL - Girona","Juan Roldan Sanchez","西班牙","Barcelona","Barcelona"],["Hospital Universitario Virgen de la Victoria - Neumología","José Luis Velasco Garrido","西班牙","Málaga","Málaga"],["Hospital Internacional Vithas Xanit","Gustavo De Luiz Martinez","西班牙","Málaga","Benalmadena Costa"],["Hospital de la Santa Creu i Sant Pau - Neumología","David Ramos Barbón","西班牙","Barcelona","Barcelona"],["Hospital Universitario Fundacion Jimenez Diaz","Carolina Maria Gotera Rivera","西班牙","Madrid","Madrid"],["Area Sanitaria De Ferrol - Nuemología","Carlota Rodríguez García","西班牙","A Coru？a","Santiago de Compostela"],["Hospital Universitario Virgen de las Nieves","Bernardino Alcázar Navarrete","西班牙","Granada","Loja"],["Pectus Respiratory Health SL - Girona","Ana Moy Millan","西班牙","Girona","Girona"],["Pectus Respiratory Health","Ana Moy Millan","西班牙","Girona","Girona"],["Mersin Universtiy Medical Faculty - Pulmonary","Sibel Nayci At？？","土耳其","Mersin","Mersin"],["Ondokuz Mayis University Medical Faculty","Nurhan Koksal","土耳其","Samsun","Samsun"],["T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi","Bahar Kurt","土耳其","Ankara","Ankara"],["Akdeniz University Medical Faculty - Pulmonology","Aykut Cilli","土耳其","Antalya","Antalya"],["Medical Park Kocaeli Hospital","Ahmet Ilgazl？","土耳其","Kocaeli","Kocaeli"],["University Hospital Southampton NHS Foundation Trust","Thomas (Tom) Wilkinson","英国","Southampton","Southampton"],["Medicines Evaluation Unit (MEU)","Sukh Singh","英国","Greater Manchester","Manchester"],["Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital","Rachel Penfold","英国","Bridgewater","Bridgewater"],["The Newcastle Upon Tyne Hospitals NHS Trust","Nicholas Lane","英国","Newcastle upon Tyne","North Shields"],["Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital","Nawar Bakerly","英国","Salford","Salford"],["London North West University Healthcare NHS Trust - Northwick Park Hospital","Camus Nimmo","英国","Harrow","Harrow"],["Guy’s and St Thomas’ NHS Foundation Trust - Guy's Hospital","Amy Dewar","英国","London","London"],["Kern Research Inc.","Tonny Tanus","美国","California","Bakersfield"],["Metroplex Pulmonary and Sleep Center - Research","Shahrukh Kureishy","美国","Texas","McKinney"],["American Health Research","Selwyn Spangenthal","美国","North Carolina","Charlotte"],["Velocity Clinical Research - Medford","Sarah Smiley","美国","Oregon","Medford"],["Clinical Research Associates of Central PA, LLC","Sandeep Bansal","美国","Pennsylvania","DuBois"],["Research Institute of South Florida","Roberto Sotolongo","美国","Florida","Miami"],["Midwest Clinical Research LLC","Robert Onder","美国","Missouri","Saint Louis"],["DM Clinical Research - Tomball","Mustafa Naeem","美国","Texas","Tomball"],["Clinical Research of Rock Hill","Michael Denenberg","美国","South Carolina","Kings Mountain"],["Centricity Research - Georgia","Maria Mascolo","美国","Georgia","Rincon"],["Finlay Medical Research","Lilia Rodriguez-Ables","美国","Florida","Miami"],["Allianz Research Institute Inc.","Kareem Ahmad","美国","California","Westminster"],["Velocity Clinical Research- Union","Joseph Boscia","美国","South Carolina","Union"],["Temple University Hospital - Lung Center","Gerard Criner","美国","Pennsylvania","Philadelphia"],["Velocity Clinical Research, Spartanburg - Pulmonology","Farhan Siddiqui","美国","South Carolina","Spartanburg"],["DM Clinical Research - Seattle","Emily Zaragoza","美国","Washington","seattle"],["Remington-Davis, Inc","Edward Cordasco","美国","Ohio","Columbus"],["TTS Research","David Fuentes","美国","Texas","Boerne"],["Direct Helpers Research Center - Clinical Research","Alberto Manzor","美国","Florida","Hialeah"]]

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","2026-06-30"]]

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: 37 ； 国际: 402 ；
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；