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Randomiseret, dobbeltblind undersøgelse af effektivitet og sikkerhed af Bexotegrast (PLN-74809) for idiopatisk lungefibrose

3. august 2026 opdateret af: Pliant Therapeutics, Inc.

Et randomiseret, dobbeltblindt, dosisvarierende, placebokontrolleret studie til evaluering af effektiviteten og sikkerheden af ​​Bexotegrast (PLN-74809) til behandling af idiopatisk lungefibrose (BEACON-IPF)

En randomiseret, dobbelt-blind, dosis-rangerende, placebo-kontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af ​​bexotegrast (PLN-74809) til behandling af idiopatisk lungefibrose (BEACON-IPF).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et randomiseret, dobbelt-blindt, dosisområde, placebokontrolleret studie for at evaluere effektiviteten og sikkerheden af ​​2 doser bexotegrast (PLN-74809) [160 og 320 mg] taget i 52 uger af deltagere med IPF, der tager og ikke tager baggrundsterapi (dvs. nintedanib eller pirfenidon).

Undersøgelsen vil bestå af en screeningsperiode på op til 28 dage, en 52-ugers behandlingsperiode og en 14 dages sikkerhedsopfølgningsperiode. Det skal bemærkes, at deltagere, som ikke tager baggrundsterapi ved studiestart, vil få lov til at påbegynde det på et hvilket som helst tidspunkt i løbet af undersøgelsen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

320

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. ≥ 40 år før screening
  2. IPF-diagnose ≤ 7 år før screening
  3. FVCpp ≥ 45 %
  4. Diffuserende kapacitet for forudsagt kulilteprocent (hæmoglobinjusteret) ≥ 30 % og < 90 %
  5. Nuværende behandling for IPF med baggrundsterapi er tilladt, hvis i en stabil dosis i ≥ 12 uger før screening
  6. Hvis deltageren ikke i øjeblikket modtager behandling for IPF (enten behandlingsnaiv eller afbrudt tidligere behandling), må deltageren ikke have taget baggrundsbehandling i mindst 8 uger før screening

Ekskluderingskriterier:

  1. Modtager farmakologisk behandling for pulmonal hypertension
  2. Selvrapporteret rygning af enhver art (ikke begrænset til tobak)
  3. Anamnese med malignitet inden for de seneste 5 år eller igangværende malignitet, bortset fra basalcellecarcinom, resekeret ikke-invasivt kutant pladecellecarcinom eller behandlet cervikal carcinom in situ
  4. Nedsat leverfunktion eller leversygdom i slutstadiet
  5. Nedsat nyrefunktion eller nyresygdom i slutstadiet, der kræver dialyse
  6. Gravid eller ammende kvindelig deltager
  7. Ukontrolleret systemisk arteriel hypertension
  8. Modtagelse af ethvert ikke-godkendt eller forsøgsmiddel beregnet til behandling af fibrose i IPF
  9. Forudgående administration af bexotegrast
  10. Sandsynligvis at få lungetransplantation under undersøgelsen (at være på transplantationslisten er ikke en udelukkelse)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Placebo
Medicin: Placebo
Placebo
Eksperimentel: Bexotegrast (PLN-74809) 160 mg Dosis
Bexotegrast (PLN-74809) 160 mg Dosis - 52 uger
Medicin: PLN-74809
PLN-74809
Eksperimentel: Bexotegrast (PLN-74809) 320 mg Dosis
Bexotegrast (PLN-74809) 320 mg Dosis - 52 uger
Medicin: PLN-74809
PLN-74809

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Forced Vital Capacity at Week 52
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pliant Therapeutics, Inc.

Efterforskere

  • Studieleder: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. november 2023

Primær færdiggørelse (Faktiske)

4. april 2025

Studieafslutning (Faktiske)

4. april 2025

Datoer for studieregistrering

Først indsendt

18. oktober 2023

Først indsendt, der opfyldte QC-kriterier

18. oktober 2023

Først opslået (Faktiske)

24. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PLN-74809-IPF-206
  • BEACON-IPF (Anden identifikator: Pliant Therapeutics Inc)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner