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Randomisert, dobbeltblind studie av effekt og sikkerhet av Bexotegrast (PLN-74809) for idiopatisk lungefibrose

3. august 2026 oppdatert av: Pliant Therapeutics, Inc.

En randomisert, dobbeltblind, dosevarierende, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Bexotegrast (PLN-74809) for behandling av idiopatisk lungefibrose (BEACON-IPF)

En randomisert, dobbeltblind, dosevarierende, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til bexotegrast (PLN-74809) for behandling av idiopatisk lungefibrose (BEACON-IPF).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette er en randomisert, dobbeltblind, dosevarierende, placebokontrollert studie for å evaluere effekten og sikkerheten til 2 doser bexotegrast (PLN-74809) [160 og 320 mg] tatt i 52 uker av deltakere med IPF som tar og ikke tar bakgrunnsterapi (dvs. nintedanib eller pirfenidon).

Studien vil bestå av en screeningperiode på opptil 28 dager, en 52-ukers behandlingsperiode og en 14 dagers sikkerhetsoppfølgingsperiode. Vær oppmerksom på at deltakere som ikke tar bakgrunnsterapi ved studiestart, vil få lov til å starte den når som helst i løpet av studien.

Studietype

Intervensjonell

Registrering (Faktiske)

320

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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)
  • 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
  • Belgia
      • Leuven, Belgia, 3000
        • UZ Leuvan
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgia, 8800
        • AZ Delta
  • Brasil
      • Porto Alegre, Brasil, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brasil, 90410-001
        • Hospital de Clinicas de Porto Alegre HCPA - PPDS
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 40170310
        • Hospital Cardio Pulmonar
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brasil, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
      • Porto Alegre, Rio Grande do Sul, Brasil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90160-093
        • Hospital Ernesto Dornelles
      • Porto Alegre, Rio Grande do Sul, Brasil, 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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Arizona Pulmonary Specialists
      • Phoenix, Arizona, Forente stater, 85013
        • Dignity Health-St. Josephs Hospital and Medical Center
      • Tucson, Arizona, Forente stater, 85724
        • Banner University Medical Center
    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center
      • New Port Beach, California, Forente stater, 92663
        • Newport Native MD, Inc
      • Palm Springs, California, Forente stater, 92262
        • Palmtree Clinical Research
      • Palo Alto, California, Forente stater, 94304
        • VA Palo Alto Health Care System
      • Redding, California, Forente stater, 96001
        • Paradigm Clinical Research Institute Inc - ClinEdge
      • Sacramento, California, Forente stater, 95807
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Forente stater, 94143
        • UCSF Medical Center - Pulmonary Practice
      • Santa Barbara, California, Forente stater, 93105
        • Jeffrey S. Sager, MD Medical Corporation
      • Stanford, California, Forente stater, 94305
        • Stanford Health Care
    • Colorado
      • Aurora, Colorado, Forente stater, 80048
        • University of Colorado
      • Denver, Colorado, Forente stater, 80206
        • National Jewish Health Main Campus
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        • Critical Care, Pulmonary and Sleep Associates
    • Connecticut
      • Danbury, Connecticut, Forente stater, 06810
        • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
      • New Haven, Connecticut, Forente stater, 06510
        • Yale New Haven Hospital - York Street Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, Forente stater, 32608
        • Malcom Randall VA Medical Center
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic Jacksonville
      • Kissimmee, Florida, Forente stater, 34746
        • Clinical Research Specialists, LLC
      • Leesburg, Florida, Forente stater, 34738
        • Clinical Site Partners - Leesburg
      • Orlando, Florida, Forente stater, 32803
        • Central Florida Pulmonary Group PA
      • Tampa, Florida, Forente stater, 33609
        • GCP Clinical Research
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory Clinic
      • Augusta, Georgia, Forente stater, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern Memorial Hospital
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • IU Health Advanced Heart and Lung Care
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40508
        • Lexington VA Medical Center
      • Louisville, Kentucky, Forente stater, 40202
        • Norton Pulmonary Specialists
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, Forente stater, 21224
        • The Johns Hopkins Hospital JHH
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Israel Deaconess Medical Cente
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Womans Hospital
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital - Pulmonary Associates
      • North Dartmouth, Massachusetts, Forente stater, 02747
        • Infinity Medical Research
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Health System
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Medical Center, Fairview
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63017
        • The Lung Research Center
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, Forente stater, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forente stater, 10032
        • New York Presbyterian Hospital-Columbia University Medical Center
      • New York, New York, Forente stater, 10032
        • Weill Cornell Medicine
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center Moses Division Hospital
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, Forente stater, 27403
        • PulmonIx, LLC
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forente stater, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • OU Health Physicians
    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • Bend Memorial Clinic/Summit Medical Group - Eastside
      • Portland, Oregon, Forente stater, 97232
        • Legacy Good Samaritan Hospital
    • Pennsylvania
      • DuBois, Pennsylvania, Forente stater, 15801
        • Clinical Research Associates Of Central Pa , Llc
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Forente stater, 29615
        • Velocity Clinical Research
      • North Charleston, South Carolina, Forente stater, 29406
        • Lowcountry Lung and Critical Care PA
    • Tennessee
      • Franklin, Tennessee, Forente stater, 37067
        • Clinical Trials Center of Middle Tennessee
      • Knoxville, Tennessee, Forente stater, 37920
        • University of Tennessee Medical Center
      • Knoxville, Tennessee, Forente stater, 37909
        • Statcare Pulmonary Consultants - Knoxville
      • Nashville, Tennessee, Forente stater, 37204
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Forente stater, 75246
        • Baylor Scott and White Health - Advanced Lung Disease Specialists
      • El Paso, Texas, Forente stater, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
      • McKinney, Texas, Forente stater, 75071
        • Research Centers of America
      • The Woodlands, Texas, Forente stater, 77380
        • Renovatio Clinical Research
      • Waxahachie, Texas, Forente stater, 75165
        • Topline Clinical Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84108
        • University of Utah
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • University of Vermont Medical Center
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
        • Inova Fairfax Medical Campus
    • Washington
      • Everett, Washington, Forente stater, 98208
        • Western Washington Medical Group
  • Frankrike
      • Bordeaux, Frankrike
        • CHU de Bordeaux- Hopital du Haut Lévêque
      • Lyon, Frankrike
        • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
      • Marseille, Frankrike
        • Hôpital Nord - CHU Marseille
      • Montpellier, Frankrike
        • CHU Arnaud de Villeneuve
      • Nice, Frankrike
        • CHU Nice - Hôpital Pasteur
      • Nice, Frankrike
        • Hopital Pasteur CHU Nice
      • Paris, Frankrike
        • Hopital Bichat - Claude Bernard
      • Paris, Frankrike
        • Hospital Bretonneau
      • Pessac, Frankrike
        • Hopital Haut-Leveque Pharmacie
      • Reims, Frankrike
        • CHU Reims - Hôpital Maison Blanche
      • Toulouse, Frankrike
        • Hopital Larrey
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, Frankrike, 35000
        • Hôpital Pontchaillou
    • Nord
      • Lille, Nord, Frankrike, 59037
        • Institut Coeur Poumon - CHU de Lille
    • Seine St Denis
      • Bobigny, Seine St Denis, Frankrike, 93000
        • Hopital Avicenne
  • Hellas
      • Heraklion, Hellas, 71110
        • University General Hospital of Heraklion
    • Achaïa
      • Pátrai, Achaïa, Hellas, 265 04
        • University General Hospital of Patras
    • Attica
      • Athens, Attica, Hellas, 115 27
        • Sotiria Thoracic Diseases Hospital of Athens
    • Evros
      • Alexandroupoli, Evros, Hellas, 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
  • 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
  • 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
  • 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
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Hospital Organization
      • Kobe, Hyōgo, Japan, 6500047
        • 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
    • Osaka
      • 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
        • Saitama Red Cross Hospital
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Shimane University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo-To
      • Bunkyō City, Tokyo-To, Japan, 113-8519
        • Institute of Science Tokyo Hospital
      • Bunkyō City, Tokyo-To, Japan, 113-8603
        • Nippon Medical School Hospital
      • Hachioji-shi, Tokyo-To, Japan, 192-0081
        • NHO Okinawa National Hospital
      • Minatoku, Tokyo-To, Japan, 105-0023
        • Juntendo University Hospital
  • Kina
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        • The Second Hospital of Anhui Medical University
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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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        • The 3rd Hospital of Hebei Medical University
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        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, Kina, 450000
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    • Hubei
      • Yichang, Hubei, Kina, 443000
        • Yichang Central People's Hospital
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      • Changsha, Hunan, Kina, 410008
        • The Second Xiangya Hospital of Central South University
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        • Wuxi People's Hospital
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        • The Affiliated Hospital of Xuzhou Medical College
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        • The First Affiliated Hospital of Nanchang University
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        • Shengjing Hospital of China Medical University
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        • Qilu Hospital of Shandong University
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        • West China Hospital, Sichuan University
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        • Royal Brompton Hospital
    • North Humberside
      • Cottingham, North Humberside, Storbritannia, HU16 5JQ
        • Castle Hill Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, Storbritannia, OX3 7LE
        • Churchill Hospital
    • West Yorkshire
      • Wakefield, West Yorkshire, Storbritannia, WF1 4DG
        • Pinderfields General Hospital
  • Sør -Korea
      • Busan, Sør -Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Seoul, Sør -Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Gyeongsangnam-do
      • Pusan, Gyeongsangnam-do, Sør -Korea, 50834
        • Inje University Busan Paik Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 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
  • Tsjekkia
      • Prague, Tsjekkia, 140 00
        • Fakultni Thomayerova nemocnice
    • Olomouc Region
      • Olomouc, Olomouc Region, Tsjekkia, 779 00
        • Fakultni Nemocnice Olomouc
    • South Moravian
      • Brno, South Moravian, Tsjekkia, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. ≥ 40 år før screening
  2. IPF-diagnose ≤ 7 år før screening
  3. FVCpp ≥ 45 %
  4. Diffuserende kapasitet for karbonmonoksidprosent predikert (hemoglobinjustert) ≥ 30 % og < 90 %
  5. Gjeldende behandling for IPF med bakgrunnsterapi er tillatt, hvis den er i en stabil dose i ≥ 12 uker før screening
  6. Dersom deltakeren ikke mottar behandling for IPF (enten behandlingsnaiv eller avbrutt tidligere behandling), må deltakeren ikke ha tatt bakgrunnsbehandling i minst 8 uker før screening

Ekskluderingskriterier:

  1. Mottar farmakologisk terapi for pulmonal hypertensjon
  2. Selvrapportert røyking av noe slag (ikke begrenset til tobakk)
  3. Anamnese med malignitet i løpet av de siste 5 årene eller pågående malignitet annet enn basalcellekarsinom, resekert ikke-invasivt kutant plateepitelkarsinom eller behandlet cervical carcinom in situ
  4. Nedsatt leverfunksjon eller leversykdom i sluttstadiet
  5. Nedsatt nyrefunksjon eller nyresykdom i sluttstadiet som krever dialyse
  6. Gravid eller ammende kvinnelig deltaker
  7. Ukontrollert systemisk arteriell hypertensjon
  8. Motta ethvert ikke-godkjent eller undersøkelsesmiddel beregnet for behandling av fibrose i IPF
  9. Tidligere administrering av bexotegrast
  10. Sannsynligvis få lungetransplantasjon under studien (å være på transplantasjonslisten er ikke en ekskludering)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Placebo
Legemiddel: Placebo
Placebo
Eksperimentell: Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 160 mg Dose - 52 uker
Legemiddel: PLN-74809
PLN-74809
Eksperimentell: Bexotegrast (PLN-74809) 320 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose - 52 uker
Legemiddel: PLN-74809
PLN-74809

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pliant Therapeutics, Inc.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. november 2023

Primær fullføring (Faktiske)

4. april 2025

Studiet fullført (Faktiske)

4. april 2025

Datoer for studieregistrering

Først innsendt

18. oktober 2023

Først innsendt som oppfylte QC-kriteriene

18. oktober 2023

Først lagt ut (Faktiske)

24. oktober 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere