北京BI1015550III期临床试验-一项旨在评估nerandomilast是否有助于风湿性疾病相关肺纤维化患者的研究

登记号	CTR20251234	试验状态	进行中
申请人联系人	勃林格殷格翰临床试验信息公示组	首次公示信息日期	2025-04-02
申请人名称	Boehringer Ingelheim International GmbH/ 勃林格殷格翰(中国)投资有限公司/ Boehringer Ingelheim Pharma GmbH & Co. KG

登记号	CTR20251234
相关登记号	暂无
药物名称	BI 1015550
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	系统性自身免疫性风湿性疾病相关间质性肺疾病（SARD-ILD）
试验专业题目	一项在系统性自身免疫性风湿性疾病相关间质性肺疾病（SARD-ILD）患者中评价nerandomilast治疗26周的疗效和安全性的双盲、随机、安慰剂对照试验
试验通俗题目	一项旨在评估nerandomilast是否有助于风湿性疾病相关肺纤维化患者的研究
试验方案编号	1305-0046	方案最新版本号	2.0
版本日期:	2024-11-21	方案是否为联合用药	否

申请人名称	[["Boehringer Ingelheim International GmbH"],["勃林格殷格翰(中国)投资有限公司"],["Boehringer Ingelheim Pharma GmbH & Co. KG"]]
联系人姓名	勃林格殷格翰临床试验信息公示组	联系人座机	021-52883966	联系人手机号
联系人Email	MEDCTIDgroup.CN@boehringer-ingelheim.com	联系人邮政地址	上海市-上海市-静安区南京西路1601号越洋广场29楼	联系人邮编	200040

本研究的主要目的是了解研究药物nerandomilast如何影响患有全身性自身免疫性风湿病患者的肺部。

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	[["签署知情同意书时患者年龄≥18岁（或高于当地法规规定的法定年龄）"],["男性或女性受试者。"],["受试者患有系统性自身免疫性风湿性疾病相关间质性肺疾病（SARD-ILD），定义为na.经风湿免疫科医生诊断为以下SARD之一：类风湿性关节炎（RA）、系统性硬化症（SSc）（受试者必须为抗着丝点自身抗体阴性）、特发性炎症性肌病（IIM）、舍格林病或混合性结缔组织病（MCTD）nb.中心审查根据访视1前12个月内进行的HRCT或访视2前进行的基线HRCT（如果历史扫描不可用）确认存在纤维化ILD，定义为存在网状异常伴牵引性支气管扩张，伴或不伴HC且显示疾病范围>10%"],["免疫抑制剂治疗反应为无肺功能改善且ILD无具有临床意义的改善主要根据以下两个标准来判断na.访视1前15个月内通过两次（间隔≥3个月）肺量计检查确定FVC占预测值百分比的绝对改变未达到改善（不大于5%）nb. 根据临床医生的评估（包括症状、影像学检查/HRCT或研究者认为相关并记录的其他评估），认为ILD未获得具有临床意义的改善"],["访视1时FVC≥正常预测值的45%"],["访视1前3个月内或访视1时DLCO≥正常预测值的25%（经血红蛋白校正后）"],["受试者必须接受任何免疫抑制剂药物稳定治疗≥6个月（或≥3个月[IIM-ILD受试者]）且符合以下标准：na. 如果使用泼尼松，受试者必须在访视2前接受稳定剂量≥4周nb. 如果使用利妥昔单抗，受试者必须在访视2前>6个月已完成第一个周期的治疗"],["如果使用尼达尼布，受试者必须在访视2前接受稳定剂量≥12周"],["研究者认为，不会计划更改免疫抑制剂、免疫调节剂或尼达尼布的背景标准治疗"]]
排除标准	[["HRCT中机化性肺炎为主要模式"],["访视1时使用支气管扩张剂前FEV1/FVC<0.7"],["根据研究者的判断，访视1前3个月内和/或筛选期间ILD急性加重"],["访视1前8周内或筛选期间出现不稳定或未受控制的活动性血管炎"],["过去2年内存在任何自杀行为"],["过去3个月或访视1和/或访视2时有任何C-SSRS 4型或5型自杀想法"],["使用以下任何药物：在访视1前6个月内使用环磷酰胺, 访视1前8周内使用过吡非尼酮"]]

试验药	[["中文通用名:BI1015550 英文通用名:BI1015550 商品名称:NA","剂型:片剂 规格:9mg/18mg 用法用量:口服给药，用药剂量将根据前期试验的主要分析来确定。 用药时程:直至试验结束"]] 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:片剂 规格:不适用 用法用量:口服给药，与试验药匹配。 用药时程:直至试验结束"]] 序号 名称 用法

主要终点指标及评价时间	[["第26周时QILD评分[%]较基线的绝对变化","基线和第26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26周时QLF评分[%]较基线的绝对变化","基线和第26周","有效性指标"],["第26周时QGGO评分[%]较基线的绝对变化","基线和第26周","有效性指标"],["第26周时FVC[mL]较基线的绝对变化","基线和第26周","有效性指标"],["第26周时L-PF症状呼吸困难领域评分较基线的绝对变化","基线和第26周","有效性指标"],["第26周时L-PF症状咳嗽领域评分较基线的绝对变化","基线和第26周","有效性指标"],["从基线至第26周感染相关AE的发生率","基线和第26周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	李梦涛	学位	医学博士	职称	主任医师
	电话	010-69151188	Email	mengtao.li@cstar.org.cn	邮政地址	北京市-北京市-东城区帅府园1号
	邮编	100730	单位名称	中国医学科学院北京协和医院

[["中国医学科学院北京协和医院","李梦涛","中国","北京市","北京市"],["厦门大学附属第一医院","石桂秀","中国","福建省","厦门市"],["首都医科大学附属北京朝阳医院","孟娟","中国","北京市","北京市"],["浙江大学医学院附属第一医院","林进","中国","浙江省","杭州市"],["中日友好医院","卢昕","中国","北京市","北京市"],["南昌大学第一附属医院","吴锐","中国","江西省","南昌市"],["株洲市中心医院","李敬扬","中国","湖南省","株洲市"],["四川大学华西医院","谢其冰","中国","四川省","成都市"],["华中科技大学同济医学院附属同济医院","董凌莉","中国","湖北省","武汉市"],["浙江大学医学院附属第二医院","吴华香","中国","浙江省","杭州市"],["天津医科大学总医院","魏蔚","中国","天津市","天津市"],["华中科技大学同济医学院附属协和医院","李秋柏","中国","湖北省","武汉市"],["广东省人民医院","李洋","中国","广东省","广州市"],["复旦大学附属华山医院","薛愉","中国","上海市","上海市"],["四川省人民医院","朱静","中国","四川省","成都市"],["河南科技大学第一附属医院","史晓飞","中国","河南省","洛阳市"],["Royal Prince Alfred Hospital","Tamera Corte","澳大利亚","New South Wales","Camperdown, Sydney"],["The Prince Charles Hospital","John Mackintosh","澳大利亚","Queensland","Chermside"],["Fiona Stanley Hospital","Jeremy Wrobel","澳大利亚","Western Australia","Murdoch"],["St Vincent's Hospital Sydney","Claire Thomson","澳大利亚","New South Wales","Darlinghurst"],["Austin Hospital","Nicole Goh","澳大利亚","Victoria","Heidelberg"],["Krems University Hospital","Sabin Handzhiev","奥地利","NA","Krems"],["Klinikum Wels - Grieskirchen GmbH","Monika Steinmaurer","奥地利","NA","Wels"],["AKH - Medical University of Vienna","Marco Idzko","奥地利","NA","Vienna"],["University Hospital Zurich","Carmen-Marina Mihai","瑞士","NA","Zurich"],["Kantonsspital St.Gallen","Andrea Rubbert-Roth","瑞士","NA","St. Gallen"],["Hopitaux Universitaires de Geneve (HUG)","Anne Bergeron","瑞士","NA","Geneve"],["University Hospital Basel","Ulrich Walker","瑞士","NA","Basel"],["Cantonal Hospital of Aarau","Sabine Adler","瑞士","NA","Aarau"],["Neuchatel Hospital Network","Jean-Marc Fellrath","瑞士","NA","Neuchatel"],["Gesundheit Nord gGmbH | Klinikverbund Bremen","Steven Demedts","德国","NA","Bremen"],["Klinikum der Universitat Munchen AOR","Hendrik Schulze-Koops","德国","NA","Munchen"],["Universitatsklinikum Freiburg","Stephanie Finzel","德国","NA","Freiburg"],["St. Elisabeth Gruppe GmbH","Ioana Andreica","德国","NA","Herne"],["medius Kliniken gGmbH","Bastian Walz","德国","NA","Kirchheim unter Teck"],["Medizinische Hochschule Hannover","Benjamin Seeliger","德国","NA","Hannover"],["Klinikum Konstanz","Stephan Walterspacher","德国","NA","Konstanz"],["Universitatsklinikum Erlangen","Christina Bergmann","德国","NA","Erlangen"],["Universitatsklinikum Bonn AoR","Valentin Schafer","德国","NA","Bonn"],["Stadtisches Klinikum Braunschweig gGmbH","Katja Schmitt-Bieda","德国","NA","Braunschweig"],["Technische Universitat Dresden","Anne-Kathrin Tausche-Wunderlich","德国","NA","Dresden"],["Krankenhaus Porz am Rhein gGmbH","Johannes Strunk","德国","NA","Koln"],["Helios Fachklinik Vogelsang-Gommern GmbH","Eugen Feist","德国","NA","Gommern"],["Immanuel-Krankenhaus GmbH","Hans Bastian","德国","NA","Berlin"],["Charite - Universitatsmedizin Berlin","Fredrik Albach","德国","NA","Berlin"],["Universitatsklinikum Schleswig-Holstein, Campus Lubeck","Gabriela Riemekasten","德国","NA","Lubeck"],["Johannes Wesling Klinikum Minden","Gunter Assmann","德国","NA","Minden"],["Krankenhaus Barmherzige Bruder Regensburg","Georg Pongratz","德国","NA","Regensburg"],["Hospital Universitario 12 de Octubre","Patricia Carreira Delgado","西班牙","Madrid","Madrid"],["Hospital de Bellvitge","Francisco Narváez García","西班牙","NA","L'Hospitalet de Llobregat"],["Complejo Hospitalario Universitario de Vigo","Nair Perez","西班牙","Pontevedra","Vigo"],["Hospital Universitario Reina Sofia-Cordoba-40500","Alejandro Escudero","西班牙","Cordoba","Cordoba"],["Fundacion Jimenez Díaz","Olga Sanchez Pernaute","西班牙","Madrid","Madrid"],["Hospital de Basurto","Esther Ruiz","西班牙","Bizkaia","Bilbao"],["Hospital Ramon y Cajal","Jesus Loarce","西班牙","Madrid","Madrid"],["Hospital Clinico de Santiago","Maria Freire Dapena","西班牙","La Coruna","Santiago de Compostela"],["Hospital Dr. Peset","Juan Alegre Sancho","西班牙","NA","Valencia"],["Hospital Virgen del Rocio","Clara Aguilera Cross","西班牙","Sevilla","Sevilla"],["Hospital Santa Creu i Sant Pau","Ivan Castellvi Barranco","西班牙","Barcelona","Barcelona"],["Hospital Vall d'Hebron","Alfredo Guillen","西班牙","Barcelona","Barcelona"],["HOP Claude Huriez","Eric Hachulla","法国","NA","Lille"],["HOP Bichat","Philippe Dieude","法国","NA","Paris"],["HOP d'Angers","Christian Lavigne","法国","NA","Angers"],["HOP Civil","Alain Meyer","法国","NA","Strasbourg"],["HOP Sud","Eric Mensi","法国","NA","Rennes"],["HOP Rangueil","Gregory Pugnet","法国","NA","Toulouse"],["HOP Cochin","Yannick Allanore","法国","NA","Paris"],["HOP Pellegrin","Marie-Elise Truchetet","法国","NA","Bordeaux"],["Antrim Area Hospital","Paul Minnis","英国","NA","Antrim"],["Royal United Hospital, Bath","Sarah Tansley","英国","NA","Bath"],["Chapel Allerton Hospital","Paul Emery","英国","NA","Leeds"],["Royal Preston Hospital","Yussuf Haider","英国","NA","London"],["Heartlands Hospital","Christopher Huntley","英国","NA","Birmingham"],["Royal Cornwall Hospital","David Hutchinson","英国","NA","Truro"],["Royal Hallamshire Hospital","James Maxwell","英国","NA","Sheffield"],["University College Hospital","Joanna Porter","英国","NA","London"],["Royal Brompton Hospital","Elisabetta Renzoni","英国","NA","London"],["Southend University Hospital","Gouri Koduri","英国","NA","Essex"],["Luton & Dunstable University Hospital","Muhammad Nisar","英国","NA","Luton"],["Altnagelvin Area Hospital","Nazia Chaudhuri","英国","NA","Londonderry"],["St George's Hospital-London-26733","Raminder Aul","英国","NA","London"],["Azienda Ospedaliera Policlinico di Modena","Dilia Giuggioli","意大利","Emilia-Romagna","MODENA"],["Università degli Studi Padova","Elisabetta Zanatta","意大利","NA","PADOVA"],["Fondazione IRCCS Policlinico S. Matteo","Veronica Codullo","意大利","Lombardia","PAVIA"],["ASST degli Spedali Civili di Brescia","Ilaria Cavazzana","意大利","Lombardia","BRESCIA"],["A. O. Universitaria Careggi","SERENA GUIDUCCI","意大利","Toscana","Frienze"],["IRCCS San Raffaele","Lorenzo DAGNA","意大利","Lombardia","Milano"],["Fondazione IRCCS Ca’Granda-Ospedale Maggiore Policlinico","Lorenzo Beretta","意大利","Lombardia","Milano"],["Keio University Hospital","Yuko Kaneko","日本","NA","Tokyo, Shinjuku-ku"],["St. Marianna University Hospital","Kimito Kawahata","日本","NA","Kanagawa, Kawasaki"],["Sapporo Medical University Hospital","Hiroki Takahashi","日本","NA","Hokkaido, Sapporo"],["Kyoto University Hospital","Ran Sasai","日本","NA","Kyoto, Kyoto"],["Kitasato University Hospital","Kenji Oku","日本","NA","Kanagawa, Sagamihara"],["Hiroshima University Hospital","Tomohiro Sugimoto","日本","NA","Hiroshima, Hiroshima"],["Saitama Medical University Hospital","Yu Funakubo","日本","NA","Saitama, Iruma-gun"],["Nippon Medical School Hospital","Masataka Kuwana","日本","NA","Tokyo, Bunkyo-ku"],["Nagasaki University Hospital","Atsushi Kawakami","日本","NA","Nagasaki, Nagasaki"],["Osaka Medical and Pharmaceutical University Hospital","Tohru Takeuchi","日本","NA","Osaka, Takatsuki"],["Hokkaido University Hospital","Michihito Kono","日本","NA","Hokkaido, Sapporo"],["Juntendo University Hospital","Masakazu Matsushita","日本","NA","Tokyo, Bunkyo-Ku"],["Hospital of the University of Occupational and Environmental Health","Shingo Nakayamada","日本","NA","Fukuoka, Kitakyushu"],["Fujita Health University Hospital","Hidekata Yasuoka","日本","NA","Aichi, Toyoake"],["Kagawa University Hospital","Hiroaki Dobashi","日本","NA","Kagawa, Kita-gun"],["Soonchunhyang University Hospital Seoul","Hyun Sook Kim","韩国","NA","Seoul"],["Kyung Hee University Hospital","Yeon-Ah Lee","韩国","NA","Seoul"],["Seoul National University Hospital","Eun Young Lee","韩国","NA","Seoul"],["Seoul National University Bundang Hospital","Eun Ha Kang","韩国","NA","Seongnam"],["CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV","Gabriel Medrano Ramirez","墨西哥","Ciudad de Mexico","Ciudad de Mexico"],["Hospital Universitario Dr Jose Eleuterio Gonzalez","Uriel Chavarria Martinez","墨西哥","Nuevo Leon – Monterrey","Monterrey"],["Medical Care & Research SA de CV","Aaron Barrera Rodriguez","墨西哥","Yucatan - Merida","Merida"],["Centro Integral en Reumatologia, SA. de CV.","Alejandra Ramos Hernandez","墨西哥","Jalisco - Guadalajara","Guadalajara"],["Investigacion y Biomedicina de Chihuahua S.C.","Cesar Pacheco Tena","墨西哥","Chihuahua - Chihuahua","Chihuahua"],["SOLTMED SMO","Edgar Reyes Garcia","墨西哥","Ciudad de Mexico","Ciudad de Mexico"],["Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran","Tatiana Rodriguez Reyna","墨西哥","Ciudad de Mexico","Mexico"],["Erasmus Medisch Centrum-ROTTERDAM-50697","Marlies Wijsenbeek-Lourens","荷兰","NA","ROTTERDAM"],["St. Antonius ziekenhuis, locatie Nieuwegein","Marcel Veltkamp","荷兰","NA","Nieuwegein"],["Zuyderland Medisch Centrum","R.L.M. Mostard","荷兰","NA","HEERLEN"],["Akershus Universitetssykehus HF","Ragnhild Gagama","挪威","NA","Nordbyhagen"],["Sykehuset Telemark HF, Avd. Skien","Silje Heitmann","挪威","NA","Skien"],["University of Wisconsin","Stephen Halliday","美国","Wisconsin","Madison"],["University of Pittsburgh Medical Center","Chester Oddis","美国","Pennsylvania","Pittsburgh"],["University of Utah Health Sciences Center","Mary Scholand","美国","Utah","Salt Lake City"],["Piedmont Hospital","Amy Case","美国","NA","Piedmont"],["Northwell Health Physician Partners Rheumatology - Great Neck","Sonali Narain","美国","NA","New York"],["Mayo Clinic","Misbah Baqir","美国","Florida","Jacksonville"],["UT Health San Antonio","Anoop Nambiar","美国","San Antonio","Texas"],["University of South Florida","Debabrata Bandyopadhyay","美国","Tampa","Florida"],["Temple Lung Center","Gerard Criner","美国","Pennsylvania","Philadelphia"],["Augusta University","Elena Schiopu","美国","Georgia","Augusta"],["Rheumatology and Pulmonary Clinic","Wassim Saikali","美国","West Virginia","Beckley"],["The University of Texas Health Science Center at Houston","Zsuzsanna McMahan","美国","Texas","Houston"],["Cleveland Clinic","Kristin Highland","美国","Ohio","Cleveland"],["Massachusetts General Hospital","Flavia Castelino","美国","Massachusetts","Boston"],["University of Kansas Medical Center","Mark Hamblin","美国","Kansas","Kansas"],["University of Minnesota","Hyun Kim","美国","Minnesota","Minneapolis"],["NYU Langone Health","Rany Condos","美国","New York","New York"],["University of Alabama at Birmingham","Tejaswini Kulkarni","美国","Alabama","Birmingham"],["Brigham and Women's Hospital","Gregory McDermott","美国","Massachusetts","Boston"],["Evanston Hospital","Shashi Bellam","美国","Illinois","Evanston"],["Northwestern University","Bradford Bemiss","美国","Illinois","Chicago"],["Miami VA Healthcare System","Robert Jackson","美国","Florida","Miami"],["National Jewish Health","Joshua Solomon","美国","Colorado","Denver"],["University of Nebraska Medical Center","Daniel Hershberger","美国","Nebraska","Omaha"],["Yale University School of Medicine","Danielle Antin-Ozerkis","美国","Connecticut","New Haven"],["Centro Reumatologico de Caguas","Amarilis Perez De Jesus","美国","Puerto Rico","Caguas"],["Columbia University Medical Center-New York Presbyterian Hospital","Da Zhang","美国","New York","New York"],["University of California Los Angeles","Augustine Chung","美国","California","Los Angeles"],["LSU Health Sciences Center","Stephen Lindsey","美国","Louisiana","New Orleans"],["Onsite Clinical Solutions","Rakesh Patel","美国","North Carolina","Salisbury"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2024-11-07"],["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2025-01-06"],["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2025-01-27"]]

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: 27 ； 国际: 400 ；
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；