Bexotegrast (PLN-74809) 治疗特发性肺纤维化疗效和安全性的随机、双盲研究
2026年8月3日 更新者：Pliant Therapeutics, Inc.
一项评估 Bexotegrast (PLN-74809) 治疗特发性肺纤维化 (BEACON-IPF) 疗效和安全性的随机、双盲、剂量范围、安慰剂对照研究
一项随机、双盲、剂量范围、安慰剂对照研究，旨在评估贝索格司特 (PLN-74809) 治疗特发性肺纤维化 (BEACON-IPF) 的有效性和安全性。
研究概览
详细说明
这是一项随机、双盲、剂量范围、安慰剂对照研究，旨在评估服用 IPF 的参与者和未服用 IPF 的参与者服用 2 剂贝索司特 (PLN-74809) [160 和 320 mg] 52 周的有效性和安全性接受背景治疗（即尼达尼布或吡非尼酮）。
该研究将包括长达 28 天的筛选期、52 周的治疗期和 14 天的安全随访期。 值得注意的是，在研究开始时未接受背景治疗的参与者将被允许在研究期间的任何时间开始。
研究类型
介入性
注册 (实际的)
320
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Anhui
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Hefei、Anhui、中国、230061
- The Second Hospital of Anhui Medical University
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Guangdong
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Guangzhou、Guangdong、中国、510515
- Nanfang Hospital of Southern Medical University
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Guangzhou、Guangdong、中国、510163
- The First Affiliated Hospital of Guangzhou Medical University
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Hebei
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Shijiazhuang、Hebei、中国、50051
- The 3rd Hospital of Hebei Medical University
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Henan
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Zhengzhou、Henan、中国、450003
- Henan Provincial People's Hospital
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Zhengzhou、Henan、中国、450000
- Henan Provincial Chest Hospital
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Hubei
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Yichang、Hubei、中国、443000
- Yichang Central People's Hospital
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Hunan
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Changsha、Hunan、中国、410008
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Wuxi、Jiangsu、中国、214023
- Wuxi People's Hospital
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Xuzhou、Jiangsu、中国、221006
- The Affiliated Hospital of Xuzhou Medical College
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Jiangxi
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Nanchang、Jiangxi、中国、330209
- The First Affiliated Hospital of Nanchang University
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Liaoning
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Shenyang、Liaoning、中国、110004
- Shengjing Hospital of China Medical University
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Shandong
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Jinan、Shandong、中国、250012
- Qilu Hospital of Shandong University
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital, Sichuan University
-
Chengdu、Sichuan、中国、610072
- Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300052
- Tianjin Medical University General Hospital
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Zhejiang
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Hangzhou、Zhejiang、中国、310006
- Hangzhou First People's Hospital
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-
-
-
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Aarhus、丹麦、8200
- Aarhus Universitetshospital
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Aarhus、丹麦
- Aarhus Universitetshospital
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Hellerup、丹麦、2900
- Gentofte Hospital
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Odense、丹麦
- Odense Universitetshospital
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Region Syddanmark
-
Odense、Region Syddanmark、丹麦、5000
- Odense Universitetshospital
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-
-
-
-
Beersheba、以色列、84001
- Soroka University Medical Center
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Haifa、以色列、34980
- Rambam Medical Center
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Kfar Saba、以色列、4428164
- Meir Medical Center
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Petah Tikva、以色列、49100
- Rabin Medical Center
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Central District
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Rehovot、Central District、以色列、76100
- Kaplan Medical Center
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Haifa District
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Haifa、Haifa District、以色列、34362
- Lady Davis Carmel Medical Center
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Jerusalem
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Jerusalem、Jerusalem、以色列、91031
- Shaare Zedek Medical Center
-
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Southern District
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Ashkelon、Southern District、以色列、7830604
- Barzilai Medical Center
-
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Tel Aviv
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Ashkelon、Tel Aviv、以色列、78278
- Tel Aviv Sourasky Medical Center
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Ramat Gan、Tel Aviv、以色列、52394
- Sheba medical center
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-
-
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y 3H5
- Kelowna Respirology and Allergy Research
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Vancouver、British Columbia、加拿大、V6Z 1Y6
- Pacific Lung Research Center
-
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Ontario
-
Ajax、Ontario、加拿大、L1S 2J5
- Dynamic Drug Advancement
-
-
Quebec
-
Saint-Charles-Borromée、Quebec、加拿大、J6E 2B4
- CIC Joliette
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Trois-Rivières、Quebec、加拿大、G8T 7A1
- Centre d'investigation Clinique Mauricie
-
-
-
-
Gujarat
-
Surat、Gujarat、印度、395010
- Unity Hospital ICU and Trauma
-
-
Haryana
-
Faridabad、Haryana、印度、121001
- ESIC Medical College and Hospital
-
-
Karnataka
-
Belagavi、Karnataka、印度、590010
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
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Belagavi、Karnataka、印度、590016
- BHS Lakeview Hospital
-
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Maharashtra
-
Mumbai、Maharashtra、印度、400007
- Bhatia Hospital
-
Nashik、Maharashtra、印度、422007
- Siddhi Hospital
-
-
Rajasthan
-
Ajmer、Rajasthan、印度、305001
- J.L.N., Medical College and Attached Hospitals
-
Jaipur、Rajasthan、印度、302023
- Asthma Bhavan
-
-
Uttar Pradesh
-
Lucknow、Uttar Pradesh、印度、226006
- Midland Healthcare & Research Center
-
-
West Bengal
-
Kolkata、West Bengal、印度、700027
- Calcutta Medical Research Institute
-
Kolkata、West Bengal、印度、700053
- B. P. Poddar Hospital and Medical Research Limited
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-
-
-
-
Kaohsiung City、台湾、807
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
-
Taichung、台湾、40447
- China Medical University Hospital
-
Taichung、台湾
- Taichung Veterans General Hospital
-
Taipei、台湾、10002
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taipei、台湾、220
- Far Eastern Memorial Hospital
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-
-
-
-
Porto Alegre、巴西、90610-000
- Hospital Sao Lucas da PUCRS
-
Porto Alegre、巴西、90410-001
- Hospital de Clinicas de Porto Alegre HCPA - PPDS
-
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Estado de Bahia
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Salvador、Estado de Bahia、巴西、40170310
- Hospital Cardio Pulmonar
-
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Minas Gerais
-
Belo Horizonte、Minas Gerais、巴西、30150-221
- Santa Casa de Misericordia de Belo Horizonte
-
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Rio Grande do Sul
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Passo Fundo、Rio Grande do Sul、巴西、99010-120
- Instituto Méderi de Pesquisa e Saúde
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Porto Alegre、Rio Grande do Sul、巴西、90050-170
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre、Rio Grande do Sul、巴西、90160-093
- Hospital Ernesto Dornelles
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Porto Alegre、Rio Grande do Sul、巴西、91010-006
- Hospital Nossa Senhora da Conceicao
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-
-
-
-
Heraklion、希腊、71110
- University General Hospital of Heraklion
-
-
Achaïa
-
Pátrai、Achaïa、希腊、265 04
- University General Hospital of Patras
-
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Attica
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Athens、Attica、希腊、115 27
- Sotiria Thoracic Diseases Hospital of Athens
-
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Evros
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Alexandroupoli、Evros、希腊、681 00
- University General Hospital of Alexandroupolis
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-
-
-
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Coswig、德国、01640
- Fachkrankenhaus Coswig GmbH
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Frankfurt、德国
- IKF Pneumologie GmbH & Co. KG
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Homburg、德国
- Universitaetsklinikum des Saarlandes
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Leipzig、德国
- Universitaetsklinikum Leipzig AoeR
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Bavaria
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München、Bavaria、德国、81377
- LMU Klinikum der Universität München - Campus Großhadern
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Lower Saxony
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Hanover、Lower Saxony、德国、30625
- Medizinische Hochschule Hannover
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North Rhine-Westphalia
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Cologne、North Rhine-Westphalia、德国、51109
- Kliniken der Stadt Koln
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Essen、North Rhine-Westphalia、德国、45239
- Ruhrlandklinik
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Schleswig-Holstein
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Kiel、Schleswig-Holstein、德国、24105
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
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State of Berlin
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Berlin、State of Berlin、德国、13125
- Evangelische Lungenklinik Berlin
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-
-
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Alessandria
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Alessandria、Alessandria、意大利、15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
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Bergamo
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Bergamo、Bergamo、意大利、24127
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
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Firenze
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Florence、Firenze、意大利、50134
- Azienda Ospedaliera Universitaria Careggi
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Foggia
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Foggia、Foggia、意大利、71122
- Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
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Milano
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Milan、Milano、意大利、20123
- Ospedale San Giuseppe Multimedica SpA
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-
-
-
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Prague、捷克语、140 00
- Fakultni Thomayerova nemocnice
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Olomouc Region
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Olomouc、Olomouc Region、捷克语、779 00
- Fakultni Nemocnice Olomouc
-
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South Moravian
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Brno、South Moravian、捷克语、625 00
- Fakultni nemocnice Brno
-
-
-
-
Canterbury
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Christchurch、Canterbury、新西兰、8013
- Christchurch Hospital
-
-
North Island
-
Auckland、North Island、新西兰、1051
- Greenlane Clinical Centre
-
-
Otago
-
Dunedin、Otago、新西兰、9016
- Dunedin Hospital
-
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Waikato Region
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Hamilton、Waikato Region、新西兰、3204
- Waikato Hospital
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-
-
-
Fukuoka
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Fukuoka、Fukuoka、日本、814-0180
- Fukuoka University Hospital
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Fukuoka、Fukuoka、日本、810-0066
- NHO Kyushu Medical Center
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Iizuka-shi、Fukuoka、日本、820-8505
- Aso Co.,Ltd Iizuka Hospital
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Kitakyushu-shi、Fukuoka、日本、807-8556
- Hospital of the University of Occupational and Environmental Health
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Fukushima
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Fukushima、Fukushima、日本、960-1295
- Fukushima Medical University Hospital
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Hiroshima
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Hiroshima、Hiroshima、日本、732-0827
- Hiroshima Prefectural Hospital
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Hokkaido
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Sapporo、Hokkaido、日本、060-0001
- Sapporo Medical University Hospital
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Hyōgo
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Kobe、Hyōgo、日本、650-0047
- Kobe City Hospital Organization
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Kobe、Hyōgo、日本、6500047
- Center General Hospital
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Ibaraki
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Naka-gun、Ibaraki、日本、319-1113
- NHO Ibarakihigashi National Hospital
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Kanagawa
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Kawasaki-shi、Kanagawa、日本、216-8511
- Tokushima University Hospital
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Yokohama、Kanagawa、日本、236-0051
- Kanagawa Cardiovascular and Respiratory Center
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-
Kumamoto
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Kumamoto、Kumamoto、日本、860-8556
- Kumamoto University Hospital
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Okayama-ken
-
Okayama、Okayama-ken、日本、700-8558
- Okayama University Hospital
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-
Osaka
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Osaka、Osaka、日本、591-8555
- NHO Kinki-Chuo Chest Medical Center
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-
Saitama
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Kumagaya-shi、Saitama、日本、360-0197
- Saitama Prefectural Cardiovascular and Respiratory Center
-
Saitama-shi、Saitama、日本、330-8553
- Saitama Red Cross Hospital
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Shimane
-
Izumo-shi、Shimane、日本、693-8501
- Shimane University Hospital
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-
Shizuoka
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Hamamatsu、Shizuoka、日本、431-3192
- Hamamatsu University School of Medicine, University Hospital
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Tokyo-To
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Bunkyō City、Tokyo-To、日本、113-8519
- Institute of Science Tokyo Hospital
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Bunkyō City、Tokyo-To、日本、113-8603
- Nippon Medical School Hospital
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Hachioji-shi、Tokyo-To、日本、192-0081
- NHO Okinawa National Hospital
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Minatoku、Tokyo-To、日本、105-0023
- Juntendo University Hospital
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-
-
-
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Quillota、智利、2260734
- CENRESIN
-
Santiago、智利、7500571
- Av. Providencia 1208 oficina 209
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Santiago、智利、7750495
- CEC SpA
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Santiago、智利、8330336
- Biocinetic
-
Santiago、智利、7500657
- CIMER - Centro de Investigaciones Medicas Respiratorias
-
Talca、智利、3481349
- Centro de Investigacion del Maule
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-
-
-
-
Leuven、比利时、3000
- UZ Leuvan
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-
West-Vlaanderen
-
Roeselare、West-Vlaanderen、比利时、8800
- AZ Delta
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-
-
-
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Bordeaux、法国
- CHU de Bordeaux- Hopital du Haut Lévêque
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Lyon、法国
- CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
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Marseille、法国
- Hôpital Nord - CHU Marseille
-
Montpellier、法国
- CHU Arnaud de Villeneuve
-
Nice、法国
- CHU Nice - Hôpital Pasteur
-
Nice、法国
- Hopital Pasteur CHU Nice
-
Paris、法国
- Hopital Bichat - Claude Bernard
-
Paris、法国
- Hospital Bretonneau
-
Pessac、法国
- Hopital Haut-Leveque Pharmacie
-
Reims、法国
- CHU Reims - Hôpital Maison Blanche
-
Toulouse、法国
- Hopital Larrey
-
-
Ille-et-Vilaine
-
Rennes、Ille-et-Vilaine、法国、35000
- Hôpital Pontchaillou
-
-
Nord
-
Lille、Nord、法国、59037
- Institut Coeur Poumon - CHU de Lille
-
-
Seine St Denis
-
Bobigny、Seine St Denis、法国、93000
- Hopital Avicenne
-
-
-
-
-
Bydgoszcz、波兰
- Vitamed Galaj i Cichomski sp.j.
-
Gdansk、波兰、80-952
- Uniwersyteckie Centrum Kliniczne
-
Krakow、波兰、30-688
- SP ZOZ Szpital Uniwersytecki w Krakowie
-
-
Lubusz Voivodeship
-
Nowa Sól、Lubusz Voivodeship、波兰、67-100
- Twoja Przychodnia NCM
-
-
-
-
-
Midland、澳大利亚、6056
- Institute for Respiratory Health - Midland
-
-
New South Wales
-
Camperdown、New South Wales、澳大利亚、2050
- Royal Prince Alfred Hospital
-
-
Queensland
-
Chermside、Queensland、澳大利亚、4032
- Lung Research Qld
-
-
South Australia
-
Kent Town、South Australia、澳大利亚、5067
- Respiratory Clinical Trials
-
Woodville South、South Australia、澳大利亚、5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
Box Hill、Victoria、澳大利亚、3128
- Box Hill Hospital
-
Clayton、Victoria、澳大利亚、3168
- Monash Medical Centre
-
Heidelberg、Victoria、澳大利亚、3084
- Austin Health
-
Melbourne、Victoria、澳大利亚、3004
- The Alfred Hospital
-
-
Western Australia
-
Murdoch、Western Australia、澳大利亚、6050
- Fiona Stanley Hospital
-
Spearwood、Western Australia、澳大利亚、6163
- Trialswest
-
-
-
-
Alabama
-
Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
-
-
Arizona
-
Phoenix、Arizona、美国、85012
- Arizona Pulmonary Specialists
-
Phoenix、Arizona、美国、85013
- Dignity Health-St. Josephs Hospital and Medical Center
-
Tucson、Arizona、美国、85724
- Banner University Medical Center
-
-
California
-
Los Angeles、California、美国、90048
- Cedars Sinai Medical Center
-
New Port Beach、California、美国、92663
- Newport Native MD, Inc
-
Palm Springs、California、美国、92262
- Palmtree Clinical Research
-
Palo Alto、California、美国、94304
- VA Palo Alto Health Care System
-
Redding、California、美国、96001
- Paradigm Clinical Research Institute Inc - ClinEdge
-
Sacramento、California、美国、95807
- University of California Davis Comprehensive Cancer Center
-
San Francisco、California、美国、94143
- UCSF Medical Center - Pulmonary Practice
-
Santa Barbara、California、美国、93105
- Jeffrey S. Sager, MD Medical Corporation
-
Stanford、California、美国、94305
- Stanford Health Care
-
-
Colorado
-
Aurora、Colorado、美国、80048
- University of Colorado
-
Denver、Colorado、美国、80206
- National Jewish Health Main Campus
-
Lakewood、Colorado、美国、80228
- Critical Care, Pulmonary and Sleep Associates
-
-
Connecticut
-
Danbury、Connecticut、美国、06810
- Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
-
New Haven、Connecticut、美国、06510
- Yale New Haven Hospital - York Street Campus
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Gainesville、Florida、美国、32608
- Malcom Randall VA Medical Center
-
Jacksonville、Florida、美国、32224
- Mayo Clinic Jacksonville
-
Kissimmee、Florida、美国、34746
- Clinical Research Specialists, LLC
-
Leesburg、Florida、美国、34738
- Clinical Site Partners - Leesburg
-
Orlando、Florida、美国、32803
- Central Florida Pulmonary Group PA
-
Tampa、Florida、美国、33609
- GCP Clinical Research
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory Clinic
-
Augusta、Georgia、美国、30912
- Augusta University
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
-
Maywood、Illinois、美国、60153
- Loyola University Medical Center
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- IU Health Advanced Heart and Lung Care
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
-
-
Kentucky
-
Lexington、Kentucky、美国、40508
- Lexington VA Medical Center
-
Louisville、Kentucky、美国、40202
- Norton Pulmonary Specialists
-
-
Louisiana
-
New Orleans、Louisiana、美国、70112
- Tulane Medical Center
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- University of Maryland Medical Center
-
Baltimore、Maryland、美国、21224
- The Johns Hopkins Hospital JHH
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Cente
-
Boston、Massachusetts、美国、02115
- Brigham and Womans Hospital
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital - Pulmonary Associates
-
North Dartmouth、Massachusetts、美国、02747
- Infinity Medical Research
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- University of Michigan Health System
-
Detroit、Michigan、美国、48202
- Henry Ford Health System
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- University of Minnesota Medical Center, Fairview
-
Rochester、Minnesota、美国、55905
- Mayo Clinic
-
-
Missouri
-
Chesterfield、Missouri、美国、63017
- The Lung Research Center
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756
- Dartmouth Hitchcock Medical Center
-
-
New York
-
New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
-
New York、New York、美国、10032
- New York Presbyterian Hospital-Columbia University Medical Center
-
New York、New York、美国、10032
- Weill Cornell Medicine
-
The Bronx、New York、美国、10467
- Montefiore Medical Center Moses Division Hospital
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Duke University Medical Center
-
Greensboro、North Carolina、美国、27403
- PulmonIx, LLC
-
Winston-Salem、North Carolina、美国、27103
- Southeastern Research Center
-
-
Ohio
-
Cincinnati、Ohio、美国、45267
- University of Cincinnati
-
Cleveland、Ohio、美国、44195
- The Cleveland Clinic Foundation
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73104
- OU Health Physicians
-
-
Oregon
-
Bend、Oregon、美国、97701
- Bend Memorial Clinic/Summit Medical Group - Eastside
-
Portland、Oregon、美国、97232
- Legacy Good Samaritan Hospital
-
-
Pennsylvania
-
DuBois、Pennsylvania、美国、15801
- Clinical Research Associates Of Central Pa , Llc
-
Hershey、Pennsylvania、美国、17033
- Penn State Health Milton S. Hershey Medical Center
-
Philadelphia、Pennsylvania、美国、19104
- Perelman Center for Advanced Medicine
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
-
-
South Carolina
-
Charleston、South Carolina、美国、29425
- Medical University of South Carolina
-
Greenville、South Carolina、美国、29615
- Velocity Clinical Research
-
North Charleston、South Carolina、美国、29406
- Lowcountry Lung and Critical Care PA
-
-
Tennessee
-
Franklin、Tennessee、美国、37067
- Clinical Trials Center of Middle Tennessee
-
Knoxville、Tennessee、美国、37920
- University of Tennessee Medical Center
-
Knoxville、Tennessee、美国、37909
- Statcare Pulmonary Consultants - Knoxville
-
Nashville、Tennessee、美国、37204
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas、Texas、美国、75246
- Baylor Scott and White Health - Advanced Lung Disease Specialists
-
El Paso、Texas、美国、79902
- El Paso Pulmonary Association
-
Houston、Texas、美国、77030
- Baylor College of Medicine
-
McKinney、Texas、美国、75071
- Research Centers of America
-
The Woodlands、Texas、美国、77380
- Renovatio Clinical Research
-
Waxahachie、Texas、美国、75165
- Topline Clinical Research
-
-
Utah
-
Salt Lake City、Utah、美国、84108
- University of Utah
-
-
Vermont
-
Burlington、Vermont、美国、05401
- University of Vermont Medical Center
-
-
Virginia
-
Falls Church、Virginia、美国、22042
- Inova Fairfax Medical Campus
-
-
Washington
-
Everett、Washington、美国、98208
- Western Washington Medical Group
-
-
-
-
Birmingham
-
Birmingham、Birmingham、英国、B9 5SS
- Birmingham Heartlands Hospital
-
-
Cambridgeshire
-
Cambridge、Cambridgeshire、英国、CB2 0AY
- Royal Papworth Hospital
-
Peterborough、Cambridgeshire、英国、PE3 9GZ
- Peterborough City Hospital
-
-
Derry
-
Londonderry、Derry、英国、BT47 6SB
- Altnagelvin Area Hospital
-
-
Hampshire
-
Southampton、Hampshire、英国、SO16 6YD
- Southampton General Hospital
-
-
London
-
London、London、英国、SW3 6NP
- Royal Brompton Hospital
-
-
North Humberside
-
Cottingham、North Humberside、英国、HU16 5JQ
- Castle Hill Hospital
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX3 7LE
- Churchill Hospital
-
-
West Yorkshire
-
Wakefield、West Yorkshire、英国、WF1 4DG
- Pinderfields General Hospital
-
-
-
-
North Holland
-
Amsterdam、North Holland、荷兰、1081 HV
- VU Medisch Centrum
-
-
Utrecht
-
Nieuwegein、Utrecht、荷兰
- St. Antonius Ziekenhuis
-
-
-
-
-
Braga、葡萄牙、4710-243
- Hospital de Braga
-
Vila Nova de Gaia、葡萄牙、4434-502
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
-
-
Portugal
-
Lisbon、Portugal、葡萄牙、1169-024
- Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
-
-
-
-
-
Majadahonda、西班牙
- Hospital Universitario Puerta de Hierro Majadahonda
-
Málaga、西班牙
- Hospital Clinico Universitario Virgen de La Victoria
-
Santiago de Compostela、西班牙、15706
- CHUS - H. Clinico U. de Santiago
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08907
- Hospital Universitari de Bellvitge
-
-
Madrid
-
Majadahonda、Madrid、西班牙、28222
- Hospital Universitario Puerta de Hierro - Majadahonda
-
-
-
-
-
Córdoba、阿根廷、X5003DCE
- Instituto de Medicina Respiratoria
-
-
Buenos Aires
-
Mar del Plata、Buenos Aires、阿根廷、7600
- Centro de Investigaciones Medicas Mar del Plata
-
Mar del Plata、Buenos Aires、阿根廷、B7600DCK
- Instituto Ave Pulmo
-
Munro、Buenos Aires、阿根廷、B1605FRE
- Clínica Privada Independencia
-
Quilmes、Buenos Aires、阿根廷、B1878FNR
- Centro Respiratorio Quilmes
-
Vicente López、Buenos Aires、阿根廷、1602
- CEMER - Centro Medico de Enfermedades Respiratorias
-
-
Buenos Aires F.D.
-
Buenos Aires、Buenos Aires F.D.、阿根廷、C1425FVH
- Consultorios Medicos Organizacion de Buen Ayre SRL
-
-
Ciudad Autonoma Buenos Aires
-
Buenos Aires、Ciudad Autonoma Buenos Aires、阿根廷、1060
- Centro de Investigacion Clinica-CEDIC
-
Ciudad Autonoma Buenos Aires、Ciudad Autonoma Buenos Aires、阿根廷、1280
- Hospital Británico de Buenos Aires
-
-
Ciudad Autónoma de BuenosAires
-
Buenos Aires、Ciudad Autónoma de BuenosAires、阿根廷、C1426ABP
- Centro Médico Dra de Salvo
-
-
Mendoza Province
-
Mendoza、Mendoza Province、阿根廷、M5500AXR
- Fundación Scherbovsky
-
Mendoza、Mendoza Province、阿根廷、M5500CCG
- INSARES
-
-
Santa Fe Province
-
Rosario、Santa Fe Province、阿根廷、2000
- Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
-
Rosario、Santa Fe Province、阿根廷、S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
-
Rosario、Santa Fe Province、阿根廷、S2000DSV
- Sanatorio Parque de Rosario
-
-
Tucumán Province
-
San Miguel de Tucumán、Tucumán Province、阿根廷、T4000CBC
- Centro Integral de Medicina Respiratoria (CIMER)
-
-
-
-
-
Busan、韩国、48108
- Inje University Haeundae Paik Hospital
-
Seoul、韩国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、韩国、06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
-
Gyeongsangnam-do
-
Pusan、Gyeongsangnam-do、韩国、50834
- Inje University Busan Paik Hospital
-
-
Seoul Teugbyeolsi
-
Seoul、Seoul Teugbyeolsi、韩国、02841
- Korea University Anam Hospital
-
Seoul、Seoul Teugbyeolsi、韩国、04763
- Hanyang University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 筛查前年龄≥40岁
- IPF 诊断 ≤ 筛查前 7 年
- 肺活量≥45%
- 预测的一氧化碳扩散能力百分比（血红蛋白调整）≥ 30% 且 < 90%
- 如果筛选前 ≥ 12 周的稳定剂量，则允许当前 IPF 治疗与背景治疗
- 如果目前未接受 IPF 治疗（未接受过治疗或已停止先前治疗），则参与者在筛选前至少 8 周内不得接受背景治疗
排除标准：
- 接受肺动脉高压药物治疗
- 自我报告吸烟任何种类（不限于烟草）
- 过去 5 年内有恶性肿瘤病史或除基底细胞癌、切除的非浸润性皮肤鳞状细胞癌或经治疗的宫颈原位癌以外的持续恶性肿瘤
- 肝功能损害或终末期肝病
- 肾功能不全或需要透析的终末期肾病
- 怀孕或哺乳期女性参与者
- 不受控制的全身性动脉高血压
- 接受任何未经批准或正在研究的用于治疗 IPF 纤维化的药物
- 既往服用贝索司特
- 研究期间可能进行肺移植（不排除在移植名单上）
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：安慰剂
|
安慰剂
|
|
实验性的：贝索格司特 (PLN-74809) 160 毫克剂量
Bexotegrast (PLN-74809) 160 mg 剂量 - 52 周
|
PLN-74809
|
|
实验性的：贝索格司特 (PLN-74809) 320 毫克剂量
Bexotegrast (PLN-74809) 320 mg 剂量 - 52 周
|
PLN-74809
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity at Week 52
大体时间：Baseline (Day 1) and Week 52
|
The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
|
Baseline (Day 1) and Week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
大体时间：Baseline (Day 1) and Week 52
|
The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer.
Background therapy included nintedanib or pirfenidone.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
Change from baseline in FVC was assessed for participants on background therapy and not on background therapy at Baseline.
|
Baseline (Day 1) and Week 52
|
|
Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at Week 52
大体时间：Baseline (Day 1) and Week 52
|
The L-PF questionnaire was developed to assess symptoms and health-related quality of life in participants with IPF.
Questionnaire consisted of 44 items divided into 2 modules: symptoms (23 items) and impacts (21 items).
Dyspnea (shortness of breath) symptom domain consisted of 12 items, each item score ranged from 0 to 5 and cough symptom domain consisted of 6 items, each item score ranged from 0 to 4. Total score was calculated based on average of item ratings within each domain, multiplied by 100; ranged from 0 to 100 with higher scores indicated greater impairment of disease.
Baseline: data collected prior to and closest to administration of first dose of study drug (bexotegrast or placebo).
Change from Baseline in L-PF dyspnea and cough domain scores are presented here.
|
Baseline (Day 1) and Week 52
|
|
Number of Participants With an Event of Disease Progression
大体时间：Baseline (Day 1) and up to Week 52
|
Number of participants with an event of disease progression was defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
|
Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at Week 52
大体时间：Baseline (Day 1) and Week 52
|
High-resolution computerized tomography (HRCT) scans were conducted to assess the extent of QLF in the whole lung.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The CT protocol population included all participants in the ITT analysis set with evaluable HRCT imaging data per the following criteria: Baseline HRCT scans were <35 days from randomization, Participant did not experience an exacerbation or progression of IPF AE within approximately 2 weeks prior to a HRCT scan, No identification of HRCT quality issues per the HRCT Imaging Charter.
|
Baseline (Day 1) and Week 52
|
|
Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through Week 52
大体时间：Baseline (Day 1) and up to Week 52
|
Percentage of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52 was planned.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
大体时间：From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days
|
An AE was any event, side-effect, or other untoward medical occurrence that occurred in conjunction with the use of a study drug in humans, whether or not considered to have a causal relationship to the study drug.
An SAE was any untoward medical occurrence, that any dose, was life-threatening, resulted in death, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or an important medical event.
TEAEs were AEs that emerged or worsened in severity after the first administration of study drug and 14 days post last dose of study drug.
The safety population included all participants who were randomized into the study and received at least 1 dose of study drug.
|
From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days
|
|
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52
大体时间：Baseline (Day 1) and Week 52
|
The K-BILD was a brief, self-completed health status measure of ILD which contained 15 items that measured health status in 3 domains (breathlessness and activities [4 items], chest symptoms [3 items], and psychological [7 items]) on a 7-point Likert scale ranging from 0 (severe symptoms) to 6 (no symptoms at all).
The K-BILD domain and total score ranges were weighted and transformed; total score ranged from 0 to 100 with higher scores indicated best health status.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
|
Baseline (Day 1) and Week 52
|
|
Number of Participants With Disease Progression for Hazard Ratio
大体时间：Baseline (Day 1) and up to Week 52
|
Number of participants with disease progression (defined as adjudicated hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality) for hazard ratio.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Pliant Therapeutics Medical Monitor、Pliant Therapeutics, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月16日
初级完成 (实际的)
2025年4月4日
研究完成 (实际的)
2025年4月4日
研究注册日期
首次提交
2023年10月18日
首先提交符合 QC 标准的
2023年10月18日
首次发布 (实际的)
2023年10月24日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.