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Studio randomizzato in doppio cieco sull'efficacia e la sicurezza di Bexotegrast (PLN-74809) per la fibrosi polmonare idiopatica

3 agosto 2026 aggiornato da: Pliant Therapeutics, Inc.

Uno studio randomizzato, in doppio cieco, a dosaggio variabile, controllato con placebo per valutare l'efficacia e la sicurezza di Bexotegrast (PLN-74809) per il trattamento della fibrosi polmonare idiopatica (BEACON-IPF)

Uno studio randomizzato, in doppio cieco, a dosaggio variabile, controllato con placebo per valutare l'efficacia e la sicurezza di bexotegrast (PLN-74809) per il trattamento della fibrosi polmonare idiopatica (BEACON-IPF).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Si tratta di uno studio randomizzato, in doppio cieco, a dosaggio variabile, controllato con placebo per valutare l'efficacia e la sicurezza di 2 dosi di bexotegrast (PLN-74809) [160 e 320 mg] assunte per 52 settimane da partecipanti con IPF e non assumendo una terapia di base (ad esempio, nintedanib o pirfenidone).

Lo studio consisterà in un periodo di screening fino a 28 giorni, un periodo di trattamento di 52 settimane e un periodo di follow-up di sicurezza di 14 giorni. Da notare che i partecipanti che non stanno assumendo la terapia di base all'ingresso nello studio potranno iniziarla in qualsiasi momento durante lo studio.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

320

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Córdoba, Argentina, X5003DCE
        • Instituto de Medicina Respiratoria
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Medicas Mar del Plata
      • Mar del Plata, Buenos Aires, Argentina, B7600DCK
        • Instituto Ave Pulmo
      • Munro, Buenos Aires, Argentina, B1605FRE
        • Clínica Privada Independencia
      • Quilmes, Buenos Aires, Argentina, B1878FNR
        • Centro Respiratorio Quilmes
      • Vicente López, Buenos Aires, Argentina, 1602
        • CEMER - Centro Medico de Enfermedades Respiratorias
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1425FVH
        • Consultorios Medicos Organizacion de Buen Ayre SRL
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1060
        • Centro de Investigacion Clinica-CEDIC
      • Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1280
        • Hospital Británico de Buenos Aires
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
        • Centro Médico Dra de Salvo
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, M5500AXR
        • Fundación Scherbovsky
      • Mendoza, Mendoza Province, Argentina, M5500CCG
        • INSARES
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Sanatorio Parque de Rosario
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
        • Centro Integral de Medicina Respiratoria (CIMER)
  • Australia
      • Midland, Australia, 6056
        • Institute for Respiratory Health - Midland
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Lung Research Qld
    • South Australia
      • Kent Town, South Australia, Australia, 5067
        • Respiratory Clinical Trials
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6050
        • Fiona Stanley Hospital
      • Spearwood, Western Australia, Australia, 6163
        • Trialswest
  • Belgio
      • Leuven, Belgio, 3000
        • UZ Leuvan
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgio, 8800
        • AZ Delta
  • Brasile
      • Porto Alegre, Brasile, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brasile, 90410-001
        • Hospital de Clinicas de Porto Alegre HCPA - PPDS
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasile, 40170310
        • Hospital Cardio Pulmonar
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasile, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brasile, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
      • Porto Alegre, Rio Grande do Sul, Brasile, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasile, 90160-093
        • Hospital Ernesto Dornelles
      • Porto Alegre, Rio Grande do Sul, Brasile, 91010-006
        • Hospital Nossa Senhora da Conceicao
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3H5
        • Kelowna Respirology and Allergy Research
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Pacific Lung Research Center
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Dynamic Drug Advancement
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • CIC Joliette
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Centre d'investigation Clinique Mauricie
  • Cechia
      • Prague, Cechia, 140 00
        • Fakultni Thomayerova nemocnice
    • Olomouc Region
      • Olomouc, Olomouc Region, Cechia, 779 00
        • Fakultni Nemocnice Olomouc
    • South Moravian
      • Brno, South Moravian, Cechia, 625 00
        • Fakultni nemocnice Brno
  • Chile
      • Quillota, Chile, 2260734
        • CENRESIN
      • Santiago, Chile, 7500571
        • Av. Providencia 1208 oficina 209
      • Santiago, Chile, 7750495
        • CEC SpA
      • Santiago, Chile, 8330336
        • Biocinetic
      • Santiago, Chile, 7500657
        • CIMER - Centro de Investigaciones Medicas Respiratorias
      • Talca, Chile, 3481349
        • Centro de Investigacion del Maule
  • Cina
    • Anhui
      • Hefei, Anhui, Cina, 230061
        • The Second Hospital of Anhui Medical University
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, Cina, 510163
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, Cina, 50051
        • The 3rd Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, Cina, 450003
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, Cina, 450000
        • Henan Provincial Chest Hospital
    • Hubei
      • Yichang, Hubei, Cina, 443000
        • Yichang Central People's Hospital
    • Hunan
      • Changsha, Hunan, Cina, 410008
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Wuxi, Jiangsu, Cina, 214023
        • Wuxi People's Hospital
      • Xuzhou, Jiangsu, Cina, 221006
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangxi
      • Nanchang, Jiangxi, Cina, 330209
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, Cina, 110004
        • Shengjing Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, Cina, 250012
        • Qilu Hospital of Shandong University
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, Cina, 610072
        • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 300052
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310006
        • Hangzhou First People's Hospital
  • Corea del Sud
      • Busan, Corea del Sud, 48108
        • Inje University Haeundae Paik Hospital
      • Seoul, Corea del Sud, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Corea del Sud, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Gyeongsangnam-do
      • Pusan, Gyeongsangnam-do, Corea del Sud, 50834
        • Inje University Busan Paik Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Corea del Sud, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul Teugbyeolsi, Corea del Sud, 04763
        • Hanyang University Medical Center
  • Danimarca
      • Aarhus, Danimarca, 8200
        • Aarhus Universitetshospital
      • Aarhus, Danimarca
        • Aarhus Universitetshospital
      • Hellerup, Danimarca, 2900
        • Gentofte Hospital
      • Odense, Danimarca
        • Odense Universitetshospital
    • Region Syddanmark
      • Odense, Region Syddanmark, Danimarca, 5000
        • Odense Universitetshospital
  • Francia
      • Bordeaux, Francia
        • CHU de Bordeaux- Hopital du Haut Lévêque
      • Lyon, Francia
        • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
      • Marseille, Francia
        • Hôpital Nord - CHU Marseille
      • Montpellier, Francia
        • CHU Arnaud de Villeneuve
      • Nice, Francia
        • CHU Nice - Hôpital Pasteur
      • Nice, Francia
        • Hopital Pasteur CHU Nice
      • Paris, Francia
        • Hopital Bichat - Claude Bernard
      • Paris, Francia
        • Hospital Bretonneau
      • Pessac, Francia
        • Hopital Haut-Leveque Pharmacie
      • Reims, Francia
        • CHU Reims - Hôpital Maison Blanche
      • Toulouse, Francia
        • Hopital Larrey
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, Francia, 35000
        • Hôpital Pontchaillou
    • Nord
      • Lille, Nord, Francia, 59037
        • Institut Coeur Poumon - CHU de Lille
    • Seine St Denis
      • Bobigny, Seine St Denis, Francia, 93000
        • Hopital Avicenne
  • Germania
      • Coswig, Germania, 01640
        • Fachkrankenhaus Coswig GmbH
      • Frankfurt, Germania
        • IKF Pneumologie GmbH & Co. KG
      • Homburg, Germania
        • Universitaetsklinikum des Saarlandes
      • Leipzig, Germania
        • Universitaetsklinikum Leipzig AoeR
    • Bavaria
      • München, Bavaria, Germania, 81377
        • LMU Klinikum der Universität München - Campus Großhadern
    • Lower Saxony
      • Hanover, Lower Saxony, Germania, 30625
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germania, 51109
        • Kliniken der Stadt Koln
      • Essen, North Rhine-Westphalia, Germania, 45239
        • Ruhrlandklinik
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germania, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • State of Berlin
      • Berlin, State of Berlin, Germania, 13125
        • Evangelische Lungenklinik Berlin
  • Giappone
    • Fukuoka
      • Fukuoka, Fukuoka, Giappone, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Fukuoka, Giappone, 810-0066
        • NHO Kyushu Medical Center
      • Iizuka-shi, Fukuoka, Giappone, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Kitakyushu-shi, Fukuoka, Giappone, 807-8556
        • Hospital of the University of Occupational and Environmental Health
    • Fukushima
      • Fukushima, Fukushima, Giappone, 960-1295
        • Fukushima Medical University Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Giappone, 732-0827
        • Hiroshima Prefectural Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Giappone, 060-0001
        • Sapporo Medical University Hospital
    • Hyōgo
      • Kobe, Hyōgo, Giappone, 650-0047
        • Kobe City Hospital Organization
      • Kobe, Hyōgo, Giappone, 6500047
        • Center General Hospital
    • Ibaraki
      • Naka-gun, Ibaraki, Giappone, 319-1113
        • NHO Ibarakihigashi National Hospital
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Giappone, 216-8511
        • Tokushima University Hospital
      • Yokohama, Kanagawa, Giappone, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
    • Kumamoto
      • Kumamoto, Kumamoto, Giappone, 860-8556
        • Kumamoto University Hospital
    • Okayama-ken
      • Okayama, Okayama-ken, Giappone, 700-8558
        • Okayama University Hospital
    • Osaka
      • Osaka, Osaka, Giappone, 591-8555
        • NHO Kinki-Chuo Chest Medical Center
    • Saitama
      • Kumagaya-shi, Saitama, Giappone, 360-0197
        • Saitama Prefectural Cardiovascular and Respiratory Center
      • Saitama-shi, Saitama, Giappone, 330-8553
        • Saitama Red Cross Hospital
    • Shimane
      • Izumo-shi, Shimane, Giappone, 693-8501
        • Shimane University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Giappone, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo-To
      • Bunkyō City, Tokyo-To, Giappone, 113-8519
        • Institute of Science Tokyo Hospital
      • Bunkyō City, Tokyo-To, Giappone, 113-8603
        • Nippon Medical School Hospital
      • Hachioji-shi, Tokyo-To, Giappone, 192-0081
        • NHO Okinawa National Hospital
      • Minatoku, Tokyo-To, Giappone, 105-0023
        • Juntendo University Hospital
  • Grecia
      • Heraklion, Grecia, 71110
        • University General Hospital of Heraklion
    • Achaïa
      • Pátrai, Achaïa, Grecia, 265 04
        • University General Hospital of Patras
    • Attica
      • Athens, Attica, Grecia, 115 27
        • Sotiria Thoracic Diseases Hospital of Athens
    • Evros
      • Alexandroupoli, Evros, Grecia, 681 00
        • University General Hospital of Alexandroupolis
  • India
    • Gujarat
      • Surat, Gujarat, India, 395010
        • Unity Hospital ICU and Trauma
    • Haryana
      • Faridabad, Haryana, India, 121001
        • ESIC Medical College and Hospital
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
      • Belagavi, Karnataka, India, 590016
        • BHS Lakeview Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400007
        • Bhatia Hospital
      • Nashik, Maharashtra, India, 422007
        • Siddhi Hospital
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • J.L.N., Medical College and Attached Hospitals
      • Jaipur, Rajasthan, India, 302023
        • Asthma Bhavan
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226006
        • Midland Healthcare & Research Center
    • West Bengal
      • Kolkata, West Bengal, India, 700027
        • Calcutta Medical Research Institute
      • Kolkata, West Bengal, India, 700053
        • B. P. Poddar Hospital and Medical Research Limited
  • Israele
      • Beersheba, Israele, 84001
        • Soroka University Medical Center
      • Haifa, Israele, 34980
        • Rambam Medical Center
      • Kfar Saba, Israele, 4428164
        • Meir Medical Center
      • Petah Tikva, Israele, 49100
        • Rabin Medical Center
    • Central District
      • Rehovot, Central District, Israele, 76100
        • Kaplan Medical Center
    • Haifa District
      • Haifa, Haifa District, Israele, 34362
        • Lady Davis Carmel Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israele, 91031
        • Shaare Zedek Medical Center
    • Southern District
      • Ashkelon, Southern District, Israele, 7830604
        • Barzilai Medical Center
    • Tel Aviv
      • Ashkelon, Tel Aviv, Israele, 78278
        • Tel Aviv Sourasky Medical Center
      • Ramat Gan, Tel Aviv, Israele, 52394
        • Sheba medical center
  • Italia
    • Alessandria
      • Alessandria, Alessandria, Italia, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
    • Bergamo
      • Bergamo, Bergamo, Italia, 24127
        • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
    • Firenze
      • Florence, Firenze, Italia, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Foggia
      • Foggia, Foggia, Italia, 71122
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
    • Milano
      • Milan, Milano, Italia, 20123
        • Ospedale San Giuseppe Multimedica SpA
  • Nuova Zelanda
    • Canterbury
      • Christchurch, Canterbury, Nuova Zelanda, 8013
        • Christchurch Hospital
    • North Island
      • Auckland, North Island, Nuova Zelanda, 1051
        • Greenlane Clinical Centre
    • Otago
      • Dunedin, Otago, Nuova Zelanda, 9016
        • Dunedin Hospital
    • Waikato Region
      • Hamilton, Waikato Region, Nuova Zelanda, 3204
        • Waikato Hospital
  • Olanda
    • North Holland
      • Amsterdam, North Holland, Olanda, 1081 HV
        • VU Medisch Centrum
    • Utrecht
      • Nieuwegein, Utrecht, Olanda
        • St. Antonius Ziekenhuis
  • Polonia
      • Bydgoszcz, Polonia
        • Vitamed Galaj i Cichomski sp.j.
      • Gdansk, Polonia, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Polonia, 30-688
        • SP ZOZ Szpital Uniwersytecki w Krakowie
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polonia, 67-100
        • Twoja Przychodnia NCM
  • Portogallo
      • Braga, Portogallo, 4710-243
        • Hospital de Braga
      • Vila Nova de Gaia, Portogallo, 4434-502
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
    • Portugal
      • Lisbon, Portugal, Portogallo, 1169-024
        • Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
  • Regno Unito
    • Birmingham
      • Birmingham, Birmingham, Regno Unito, B9 5SS
        • Birmingham Heartlands Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Regno Unito, CB2 0AY
        • Royal Papworth Hospital
      • Peterborough, Cambridgeshire, Regno Unito, PE3 9GZ
        • Peterborough City Hospital
    • Derry
      • Londonderry, Derry, Regno Unito, BT47 6SB
        • Altnagelvin Area Hospital
    • Hampshire
      • Southampton, Hampshire, Regno Unito, SO16 6YD
        • Southampton General Hospital
    • London
      • London, London, Regno Unito, SW3 6NP
        • Royal Brompton Hospital
    • North Humberside
      • Cottingham, North Humberside, Regno Unito, HU16 5JQ
        • Castle Hill Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, Regno Unito, OX3 7LE
        • Churchill Hospital
    • West Yorkshire
      • Wakefield, West Yorkshire, Regno Unito, WF1 4DG
        • Pinderfields General Hospital
  • Spagna
      • Majadahonda, Spagna
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Málaga, Spagna
        • Hospital Clinico Universitario Virgen de La Victoria
      • Santiago de Compostela, Spagna, 15706
        • CHUS - H. Clinico U. de Santiago
    • Barcelona
      • Barcelona, Barcelona, Spagna, 08907
        • Hospital Universitari de Bellvitge
    • Madrid
      • Majadahonda, Madrid, Spagna, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85012
        • Arizona Pulmonary Specialists
      • Phoenix, Arizona, Stati Uniti, 85013
        • Dignity Health-St. Josephs Hospital and Medical Center
      • Tucson, Arizona, Stati Uniti, 85724
        • Banner University Medical Center
    • California
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars Sinai Medical Center
      • New Port Beach, California, Stati Uniti, 92663
        • Newport Native MD, Inc
      • Palm Springs, California, Stati Uniti, 92262
        • Palmtree Clinical Research
      • Palo Alto, California, Stati Uniti, 94304
        • VA Palo Alto Health Care System
      • Redding, California, Stati Uniti, 96001
        • Paradigm Clinical Research Institute Inc - ClinEdge
      • Sacramento, California, Stati Uniti, 95807
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Stati Uniti, 94143
        • UCSF Medical Center - Pulmonary Practice
      • Santa Barbara, California, Stati Uniti, 93105
        • Jeffrey S. Sager, MD Medical Corporation
      • Stanford, California, Stati Uniti, 94305
        • Stanford Health Care
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80048
        • University of Colorado
      • Denver, Colorado, Stati Uniti, 80206
        • National Jewish Health Main Campus
      • Lakewood, Colorado, Stati Uniti, 80228
        • Critical Care, Pulmonary and Sleep Associates
    • Connecticut
      • Danbury, Connecticut, Stati Uniti, 06810
        • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
      • New Haven, Connecticut, Stati Uniti, 06510
        • Yale New Haven Hospital - York Street Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, Stati Uniti, 32608
        • Malcom Randall VA Medical Center
      • Jacksonville, Florida, Stati Uniti, 32224
        • Mayo Clinic Jacksonville
      • Kissimmee, Florida, Stati Uniti, 34746
        • Clinical Research Specialists, LLC
      • Leesburg, Florida, Stati Uniti, 34738
        • Clinical Site Partners - Leesburg
      • Orlando, Florida, Stati Uniti, 32803
        • Central Florida Pulmonary Group PA
      • Tampa, Florida, Stati Uniti, 33609
        • GCP Clinical Research
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory Clinic
      • Augusta, Georgia, Stati Uniti, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern Memorial Hospital
      • Maywood, Illinois, Stati Uniti, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • IU Health Advanced Heart and Lung Care
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40508
        • Lexington VA Medical Center
      • Louisville, Kentucky, Stati Uniti, 40202
        • Norton Pulmonary Specialists
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, Stati Uniti, 21224
        • The Johns Hopkins Hospital JHH
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Beth Israel Deaconess Medical Cente
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Womans Hospital
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital - Pulmonary Associates
      • North Dartmouth, Massachusetts, Stati Uniti, 02747
        • Infinity Medical Research
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Health System
      • Detroit, Michigan, Stati Uniti, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota Medical Center, Fairview
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, Stati Uniti, 63017
        • The Lung Research Center
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, Stati Uniti, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Stati Uniti, 10032
        • New York Presbyterian Hospital-Columbia University Medical Center
      • New York, New York, Stati Uniti, 10032
        • Weill Cornell Medicine
      • The Bronx, New York, Stati Uniti, 10467
        • Montefiore Medical Center Moses Division Hospital
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, Stati Uniti, 27403
        • PulmonIx, LLC
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Stati Uniti, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • OU Health Physicians
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Bend Memorial Clinic/Summit Medical Group - Eastside
      • Portland, Oregon, Stati Uniti, 97232
        • Legacy Good Samaritan Hospital
    • Pennsylvania
      • DuBois, Pennsylvania, Stati Uniti, 15801
        • Clinical Research Associates Of Central Pa , Llc
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Stati Uniti, 29615
        • Velocity Clinical Research
      • North Charleston, South Carolina, Stati Uniti, 29406
        • Lowcountry Lung and Critical Care PA
    • Tennessee
      • Franklin, Tennessee, Stati Uniti, 37067
        • Clinical Trials Center of Middle Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920
        • University of Tennessee Medical Center
      • Knoxville, Tennessee, Stati Uniti, 37909
        • Statcare Pulmonary Consultants - Knoxville
      • Nashville, Tennessee, Stati Uniti, 37204
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Baylor Scott and White Health - Advanced Lung Disease Specialists
      • El Paso, Texas, Stati Uniti, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
      • McKinney, Texas, Stati Uniti, 75071
        • Research Centers of America
      • The Woodlands, Texas, Stati Uniti, 77380
        • Renovatio Clinical Research
      • Waxahachie, Texas, Stati Uniti, 75165
        • Topline Clinical Research
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84108
        • University of Utah
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • University of Vermont Medical Center
    • Virginia
      • Falls Church, Virginia, Stati Uniti, 22042
        • Inova Fairfax Medical Campus
    • Washington
      • Everett, Washington, Stati Uniti, 98208
        • Western Washington Medical Group
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  1. ≥ 40 anni di età prima dello screening
  2. Diagnosi di IPF ≤ 7 anni prima dello screening
  3. FVCpp ≥ 45%
  4. Capacità di diffusione del monossido di carbonio percentuale prevista (aggiustata per l'emoglobina) ≥ 30% e < 90%
  5. Il trattamento attuale per l'IPF con terapia di base è consentito, se a una dose stabile per ≥ 12 settimane prima dello screening
  6. Se non sta attualmente ricevendo un trattamento per l'IPF (naïve al trattamento o interrotto in precedenza), il partecipante non deve aver assunto la terapia di base per almeno 8 settimane prima dello screening

Criteri di esclusione:

  1. In terapia farmacologica per l'ipertensione polmonare
  2. Fumo autodichiarato di qualsiasi tipo (non limitato al tabacco)
  3. Anamnesi di tumore maligno negli ultimi 5 anni o tumore maligno in corso diverso dal carcinoma basocellulare, carcinoma cutaneo a cellule squamose resecato non invasivo o carcinoma cervicale trattato in situ
  4. Insufficienza epatica o malattia epatica allo stadio terminale
  5. Insufficienza renale o malattia renale allo stadio terminale che richiede dialisi
  6. Partecipante donna in gravidanza o in allattamento
  7. Ipertensione arteriosa sistemica non controllata
  8. Ricevere qualsiasi agente non approvato o sperimentale destinato al trattamento della fibrosi nell'IPF
  9. Previa somministrazione di bexotegrast
  10. Probabilità di essere sottoposto a trapianto polmonare durante lo studio (essere nell'elenco dei trapianti non è un'esclusione)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Placebo
Droga: Placebo
Placebo
Sperimentale: Bexotegrast (PLN-74809) Dose da 160 mg
Bexotegrast (PLN-74809) Dose da 160 mg - 52 settimane
Droga: PLN-74809
PLN-74809
Sperimentale: Bexotegrast (PLN-74809) Dose da 320 mg
Bexotegrast (PLN-74809) Dose da 320 mg - 52 settimane
Droga: PLN-74809
PLN-74809

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Vital Capacity at Week 52
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pliant Therapeutics, Inc.

Investigatori

  • Direttore dello studio: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 novembre 2023

Completamento primario (Effettivo)

4 aprile 2025

Completamento dello studio (Effettivo)

4 aprile 2025

Date di iscrizione allo studio

Primo inviato

18 ottobre 2023

Primo inviato che soddisfa i criteri di controllo qualità

18 ottobre 2023

Primo Inserito (Effettivo)

24 ottobre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PLN-74809-IPF-206
  • BEACON-IPF (Altro identificatore: Pliant Therapeutics Inc)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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