Randomiserad, dubbelblind studie av effekt och säkerhet av bexotegrast (PLN-74809) för idiopatisk lungfibros
3 augusti 2026 uppdaterad av: Pliant Therapeutics, Inc.
En randomiserad, dubbelblind, dosvarierande, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten av Bexotegrast (PLN-74809) för behandling av idiopatisk lungfibros (BEACON-IPF)
En randomiserad, dubbelblind, dosvarierande, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten av bexotegrast (PLN-74809) för behandling av idiopatisk lungfibros (BEACON-IPF).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Detta är en randomiserad, dubbelblind, dosvarierande, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten av 2 doser bexotegrast (PLN-74809) [160 och 320 mg] som tagits under 52 veckor av deltagare som tagit IPF och inte tar bakgrundsterapi (dvs. nintedanib eller pirfenidon).
Studien kommer att bestå av en screeningperiod på upp till 28 dagar, en 52-veckors behandlingsperiod och en 14 dagars säkerhetsuppföljningsperiod. Observera att deltagare som inte tar bakgrundsterapi vid studiestart kommer att tillåtas påbörja den när som helst under studien.
Studietyp
Interventionell
Inskrivning (Faktisk)
320
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Córdoba, Argentina, X5003DCE
- Instituto de Medicina Respiratoria
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
- Centro de Investigaciones Medicas Mar del Plata
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Mar del Plata, Buenos Aires, Argentina, B7600DCK
- Instituto Ave Pulmo
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Munro, Buenos Aires, Argentina, B1605FRE
- Clínica Privada Independencia
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Quilmes, Buenos Aires, Argentina, B1878FNR
- Centro Respiratorio Quilmes
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Vicente López, Buenos Aires, Argentina, 1602
- CEMER - Centro Medico de Enfermedades Respiratorias
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1425FVH
- Consultorios Medicos Organizacion de Buen Ayre SRL
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Ciudad Autonoma Buenos Aires
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1060
- Centro de Investigacion Clinica-CEDIC
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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1280
- Hospital Británico de Buenos Aires
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
- Centro Médico Dra de Salvo
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Mendoza Province
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Mendoza, Mendoza Province, Argentina, M5500AXR
- Fundación Scherbovsky
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Mendoza, Mendoza Province, Argentina, M5500CCG
- INSARES
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Sanatorio Parque de Rosario
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
- Centro Integral de Medicina Respiratoria (CIMER)
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Midland, Australien, 6056
- Institute for Respiratory Health - Midland
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New South Wales
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Camperdown, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside, Queensland, Australien, 4032
- Lung Research Qld
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South Australia
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Kent Town, South Australia, Australien, 5067
- Respiratory Clinical Trials
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Woodville South, South Australia, Australien, 5011
- The Queen Elizabeth Hospital
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Victoria
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Box Hill, Victoria, Australien, 3128
- Box Hill Hospital
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Clayton, Victoria, Australien, 3168
- Monash Medical Centre
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Heidelberg, Victoria, Australien, 3084
- Austin Health
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital
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Western Australia
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Murdoch, Western Australia, Australien, 6050
- Fiona Stanley Hospital
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Spearwood, Western Australia, Australien, 6163
- Trialswest
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Leuven, Belgien, 3000
- UZ Leuvan
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgien, 8800
- AZ Delta
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Porto Alegre, Brasilien, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Brasilien, 90410-001
- Hospital de Clinicas de Porto Alegre HCPA - PPDS
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 40170310
- Hospital Cardio Pulmonar
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brasilien, 99010-120
- Instituto Méderi de Pesquisa e Saúde
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Porto Alegre, Rio Grande do Sul, Brasilien, 90050-170
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilien, 90160-093
- Hospital Ernesto Dornelles
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Porto Alegre, Rio Grande do Sul, Brasilien, 91010-006
- Hospital Nossa Senhora da Conceicao
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Quillota, Chile, 2260734
- CENRESIN
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Santiago, Chile, 7500571
- Av. Providencia 1208 oficina 209
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Santiago, Chile, 7750495
- CEC SpA
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Santiago, Chile, 8330336
- Biocinetic
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Santiago, Chile, 7500657
- CIMER - Centro de Investigaciones Medicas Respiratorias
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Talca, Chile, 3481349
- Centro de Investigacion del Maule
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-
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Aarhus, Danmark, 8200
- Aarhus Universitetshospital
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Aarhus, Danmark
- Aarhus Universitetshospital
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Hellerup, Danmark, 2900
- Gentofte Hospital
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Odense, Danmark
- Odense Universitetshospital
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Region Syddanmark
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Odense, Region Syddanmark, Danmark, 5000
- Odense Universitetshospital
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-
-
-
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Bordeaux, Frankrike
- CHU de Bordeaux- Hopital du Haut Lévêque
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Lyon, Frankrike
- CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
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Marseille, Frankrike
- Hôpital Nord - CHU Marseille
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Montpellier, Frankrike
- CHU Arnaud de Villeneuve
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Nice, Frankrike
- CHU Nice - Hôpital Pasteur
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Nice, Frankrike
- Hopital Pasteur CHU Nice
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Paris, Frankrike
- Hopital Bichat - Claude Bernard
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Paris, Frankrike
- Hospital Bretonneau
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Pessac, Frankrike
- Hopital Haut-Leveque Pharmacie
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Reims, Frankrike
- CHU Reims - Hôpital Maison Blanche
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Toulouse, Frankrike
- Hopital Larrey
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35000
- Hôpital Pontchaillou
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Nord
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Lille, Nord, Frankrike, 59037
- Institut Coeur Poumon - CHU de Lille
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Seine St Denis
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Bobigny, Seine St Denis, Frankrike, 93000
- Hopital Avicenne
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Förenta staterna, 85012
- Arizona Pulmonary Specialists
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Phoenix, Arizona, Förenta staterna, 85013
- Dignity Health-St. Josephs Hospital and Medical Center
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Tucson, Arizona, Förenta staterna, 85724
- Banner University Medical Center
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California
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Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
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New Port Beach, California, Förenta staterna, 92663
- Newport Native MD, Inc
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Palm Springs, California, Förenta staterna, 92262
- Palmtree Clinical Research
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Palo Alto, California, Förenta staterna, 94304
- VA Palo Alto Health Care System
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Redding, California, Förenta staterna, 96001
- Paradigm Clinical Research Institute Inc - ClinEdge
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Sacramento, California, Förenta staterna, 95807
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, Förenta staterna, 94143
- UCSF Medical Center - Pulmonary Practice
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Santa Barbara, California, Förenta staterna, 93105
- Jeffrey S. Sager, MD Medical Corporation
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Stanford, California, Förenta staterna, 94305
- Stanford Health Care
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Colorado
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Aurora, Colorado, Förenta staterna, 80048
- University of Colorado
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Denver, Colorado, Förenta staterna, 80206
- National Jewish Health Main Campus
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Lakewood, Colorado, Förenta staterna, 80228
- Critical Care, Pulmonary and Sleep Associates
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Connecticut
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Danbury, Connecticut, Förenta staterna, 06810
- Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
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New Haven, Connecticut, Förenta staterna, 06510
- Yale New Haven Hospital - York Street Campus
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Florida
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Gainesville, Florida, Förenta staterna, 32608
- Malcom Randall VA Medical Center
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic Jacksonville
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Kissimmee, Florida, Förenta staterna, 34746
- Clinical Research Specialists, LLC
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Leesburg, Florida, Förenta staterna, 34738
- Clinical Site Partners - Leesburg
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Orlando, Florida, Förenta staterna, 32803
- Central Florida Pulmonary Group PA
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Tampa, Florida, Förenta staterna, 33609
- GCP Clinical Research
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory Clinic
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Augusta, Georgia, Förenta staterna, 30912
- Augusta University
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern Memorial Hospital
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- IU Health Advanced Heart and Lung Care
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40508
- Lexington VA Medical Center
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Louisville, Kentucky, Förenta staterna, 40202
- Norton Pulmonary Specialists
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, Förenta staterna, 21224
- The Johns Hopkins Hospital JHH
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Cente
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Womans Hospital
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital - Pulmonary Associates
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North Dartmouth, Massachusetts, Förenta staterna, 02747
- Infinity Medical Research
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan Health System
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Health System
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Medical Center, Fairview
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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Missouri
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Chesterfield, Missouri, Förenta staterna, 63017
- The Lung Research Center
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, Förenta staterna, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Förenta staterna, 10032
- New York Presbyterian Hospital-Columbia University Medical Center
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New York, New York, Förenta staterna, 10032
- Weill Cornell Medicine
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center Moses Division Hospital
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Greensboro, North Carolina, Förenta staterna, 27403
- PulmonIx, LLC
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Southeastern Research Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267
- University of Cincinnati
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Cleveland, Ohio, Förenta staterna, 44195
- The Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- OU Health Physicians
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- Bend Memorial Clinic/Summit Medical Group - Eastside
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Portland, Oregon, Förenta staterna, 97232
- Legacy Good Samaritan Hospital
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Pennsylvania
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DuBois, Pennsylvania, Förenta staterna, 15801
- Clinical Research Associates Of Central Pa , Llc
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Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- Velocity Clinical Research
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North Charleston, South Carolina, Förenta staterna, 29406
- Lowcountry Lung and Critical Care PA
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Tennessee
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Franklin, Tennessee, Förenta staterna, 37067
- Clinical Trials Center of Middle Tennessee
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Knoxville, Tennessee, Förenta staterna, 37920
- University of Tennessee Medical Center
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Knoxville, Tennessee, Förenta staterna, 37909
- Statcare Pulmonary Consultants - Knoxville
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Nashville, Tennessee, Förenta staterna, 37204
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75246
- Baylor Scott and White Health - Advanced Lung Disease Specialists
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El Paso, Texas, Förenta staterna, 79902
- El Paso Pulmonary Association
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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McKinney, Texas, Förenta staterna, 75071
- Research Centers of America
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The Woodlands, Texas, Förenta staterna, 77380
- Renovatio Clinical Research
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Waxahachie, Texas, Förenta staterna, 75165
- Topline Clinical Research
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Utah
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Salt Lake City, Utah, Förenta staterna, 84108
- University of Utah
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Vermont
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Burlington, Vermont, Förenta staterna, 05401
- University of Vermont Medical Center
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Virginia
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Falls Church, Virginia, Förenta staterna, 22042
- Inova Fairfax Medical Campus
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Washington
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Everett, Washington, Förenta staterna, 98208
- Western Washington Medical Group
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-
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-
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Heraklion, Grekland, 71110
- University General Hospital of Heraklion
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Achaïa
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Pátrai, Achaïa, Grekland, 265 04
- University General Hospital of Patras
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Attica
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Athens, Attica, Grekland, 115 27
- Sotiria Thoracic Diseases Hospital of Athens
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Evros
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Alexandroupoli, Evros, Grekland, 681 00
- University General Hospital of Alexandroupolis
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Gujarat
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Surat, Gujarat, Indien, 395010
- Unity Hospital ICU and Trauma
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Haryana
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Faridabad, Haryana, Indien, 121001
- ESIC Medical College and Hospital
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Karnataka
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Belagavi, Karnataka, Indien, 590010
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
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Belagavi, Karnataka, Indien, 590016
- BHS Lakeview Hospital
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Maharashtra
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Mumbai, Maharashtra, Indien, 400007
- Bhatia Hospital
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Nashik, Maharashtra, Indien, 422007
- Siddhi Hospital
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Rajasthan
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Ajmer, Rajasthan, Indien, 305001
- J.L.N., Medical College and Attached Hospitals
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Jaipur, Rajasthan, Indien, 302023
- Asthma Bhavan
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indien, 226006
- Midland Healthcare & Research Center
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West Bengal
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Kolkata, West Bengal, Indien, 700027
- Calcutta Medical Research Institute
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Kolkata, West Bengal, Indien, 700053
- B. P. Poddar Hospital and Medical Research Limited
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-
-
-
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Beersheba, Israel, 84001
- Soroka University Medical Center
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Haifa, Israel, 34980
- Rambam Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Central District
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Rehovot, Central District, Israel, 76100
- Kaplan Medical Center
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Haifa District
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Haifa, Haifa District, Israel, 34362
- Lady Davis Carmel Medical Center
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Jerusalem
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Jerusalem, Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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Southern District
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Ashkelon, Southern District, Israel, 7830604
- Barzilai Medical Center
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Tel Aviv
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Ashkelon, Tel Aviv, Israel, 78278
- Tel Aviv Sourasky Medical Center
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Ramat Gan, Tel Aviv, Israel, 52394
- Sheba medical center
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-
-
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Alessandria
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Alessandria, Alessandria, Italien, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
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Bergamo
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Bergamo, Bergamo, Italien, 24127
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
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Firenze
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Florence, Firenze, Italien, 50134
- Azienda Ospedaliera Universitaria Careggi
-
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Foggia
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Foggia, Foggia, Italien, 71122
- Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
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Milano
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Milan, Milano, Italien, 20123
- Ospedale San Giuseppe Multimedica SpA
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-
-
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Fukuoka, Japan, 810-0066
- NHO Kyushu Medical Center
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Iizuka-shi, Fukuoka, Japan, 820-8505
- Aso Co.,Ltd Iizuka Hospital
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Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health
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-
Fukushima
-
Fukushima, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Hiroshima
-
Hiroshima, Hiroshima, Japan, 732-0827
- Hiroshima Prefectural Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-0001
- Sapporo Medical University Hospital
-
-
Hyōgo
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Hospital Organization
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Kobe, Hyōgo, Japan, 6500047
- Center General Hospital
-
-
Ibaraki
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Naka-gun, Ibaraki, Japan, 319-1113
- NHO Ibarakihigashi National Hospital
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-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 216-8511
- Tokushima University Hospital
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Yokohama, Kanagawa, Japan, 236-0051
- Kanagawa Cardiovascular and Respiratory Center
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-
Kumamoto
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Kumamoto, Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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-
Okayama-ken
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Okayama, Okayama-ken, Japan, 700-8558
- Okayama University Hospital
-
-
Osaka
-
Osaka, Osaka, Japan, 591-8555
- NHO Kinki-Chuo Chest Medical Center
-
-
Saitama
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Kumagaya-shi, Saitama, Japan, 360-0197
- Saitama Prefectural Cardiovascular and Respiratory Center
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Saitama-shi, Saitama, Japan, 330-8553
- Saitama Red Cross Hospital
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-
Shimane
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Izumo-shi, Shimane, Japan, 693-8501
- Shimane University Hospital
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-
Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University School of Medicine, University Hospital
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Tokyo-To
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Bunkyō City, Tokyo-To, Japan, 113-8519
- Institute of Science Tokyo Hospital
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Bunkyō City, Tokyo-To, Japan, 113-8603
- Nippon Medical School Hospital
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Hachioji-shi, Tokyo-To, Japan, 192-0081
- NHO Okinawa National Hospital
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Minatoku, Tokyo-To, Japan, 105-0023
- Juntendo University Hospital
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-
-
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 3H5
- Kelowna Respirology and Allergy Research
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Vancouver, British Columbia, Kanada, V6Z 1Y6
- Pacific Lung Research Center
-
-
Ontario
-
Ajax, Ontario, Kanada, L1S 2J5
- Dynamic Drug Advancement
-
-
Quebec
-
Saint-Charles-Borromée, Quebec, Kanada, J6E 2B4
- CIC Joliette
-
Trois-Rivières, Quebec, Kanada, G8T 7A1
- Centre d'investigation Clinique Mauricie
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-
-
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Anhui
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Hefei, Anhui, Kina, 230061
- The Second Hospital of Anhui Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Nanfang Hospital of Southern Medical University
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Guangzhou, Guangdong, Kina, 510163
- The First Affiliated Hospital of Guangzhou Medical University
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Hebei
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Shijiazhuang, Hebei, Kina, 50051
- The 3rd Hospital of Hebei Medical University
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Henan
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Zhengzhou, Henan, Kina, 450003
- Henan Provincial People's Hospital
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Zhengzhou, Henan, Kina, 450000
- Henan Provincial Chest Hospital
-
-
Hubei
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Yichang, Hubei, Kina, 443000
- Yichang Central People's Hospital
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Hunan
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Changsha, Hunan, Kina, 410008
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Wuxi, Jiangsu, Kina, 214023
- Wuxi People's Hospital
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Xuzhou, Jiangsu, Kina, 221006
- The Affiliated Hospital of Xuzhou Medical College
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Jiangxi
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Nanchang, Jiangxi, Kina, 330209
- The First Affiliated Hospital of Nanchang University
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Liaoning
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Shenyang, Liaoning, Kina, 110004
- Shengjing Hospital of China Medical University
-
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Shandong
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Jinan, Shandong, Kina, 250012
- Qilu Hospital of Shandong University
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital, Sichuan University
-
Chengdu, Sichuan, Kina, 610072
- Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
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Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300052
- Tianjin Medical University General Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310006
- Hangzhou First People's Hospital
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-
-
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North Holland
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Amsterdam, North Holland, Nederländerna, 1081 HV
- VU Medisch Centrum
-
-
Utrecht
-
Nieuwegein, Utrecht, Nederländerna
- St. Antonius Ziekenhuis
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-
-
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Canterbury
-
Christchurch, Canterbury, Nya Zeeland, 8013
- Christchurch Hospital
-
-
North Island
-
Auckland, North Island, Nya Zeeland, 1051
- Greenlane Clinical Centre
-
-
Otago
-
Dunedin, Otago, Nya Zeeland, 9016
- Dunedin Hospital
-
-
Waikato Region
-
Hamilton, Waikato Region, Nya Zeeland, 3204
- Waikato Hospital
-
-
-
-
-
Bydgoszcz, Polen
- Vitamed Galaj i Cichomski sp.j.
-
Gdansk, Polen, 80-952
- Uniwersyteckie Centrum Kliniczne
-
Krakow, Polen, 30-688
- SP ZOZ Szpital Uniwersytecki w Krakowie
-
-
Lubusz Voivodeship
-
Nowa Sól, Lubusz Voivodeship, Polen, 67-100
- Twoja Przychodnia NCM
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
Birmingham
-
Birmingham, Birmingham, Storbritannien, B9 5SS
- Birmingham Heartlands Hospital
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Storbritannien, CB2 0AY
- Royal Papworth Hospital
-
Peterborough, Cambridgeshire, Storbritannien, PE3 9GZ
- Peterborough City Hospital
-
-
Derry
-
Londonderry, Derry, Storbritannien, BT47 6SB
- Altnagelvin Area Hospital
-
-
Hampshire
-
Southampton, Hampshire, Storbritannien, SO16 6YD
- Southampton General Hospital
-
-
London
-
London, London, Storbritannien, SW3 6NP
- Royal Brompton Hospital
-
-
North Humberside
-
Cottingham, North Humberside, Storbritannien, HU16 5JQ
- Castle Hill Hospital
-
-
Oxfordshire
-
Oxford, Oxfordshire, Storbritannien, OX3 7LE
- Churchill Hospital
-
-
West Yorkshire
-
Wakefield, West Yorkshire, Storbritannien, WF1 4DG
- Pinderfields General Hospital
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
Prague, Tjeckien, 140 00
- Fakultni Thomayerova nemocnice
-
-
Olomouc Region
-
Olomouc, Olomouc Region, Tjeckien, 779 00
- Fakultni Nemocnice Olomouc
-
-
South Moravian
-
Brno, South Moravian, Tjeckien, 625 00
- Fakultni nemocnice Brno
-
-
-
-
-
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
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- ≥ 40 års ålder före screening
- IPF-diagnos ≤ 7 år före screening
- FVCpp ≥ 45 %
- Diffuseringskapacitet för kolmonoxidprocent förutspådd (hemoglobinjusterad) ≥ 30 % och < 90 %
- Nuvarande behandling för IPF med bakgrundsterapi är tillåten, om i en stabil dos i ≥ 12 veckor före screening
- Om deltagaren inte för närvarande får behandling för IPF (antingen behandlingsnaiv eller avbruten tidigare behandling), får deltagaren inte ha tagit bakgrundsterapi under minst 8 veckor före screening
Exklusions kriterier:
- Får farmakologisk terapi för pulmonell hypertoni
- Självrapporterad rökning av något slag (inte begränsat till tobak)
- Historik av malignitet under de senaste 5 åren eller pågående malignitet annan än basalcellscancer, resekerat icke-invasivt kutant skivepitelcancer eller behandlat livmoderhalscancer in situ
- Nedsatt leverfunktion eller leversjukdom i slutstadiet
- Nedsatt njurfunktion eller njursjukdom i slutstadiet som kräver dialys
- Gravid eller ammande kvinnlig deltagare
- Okontrollerad systemisk arteriell hypertoni
- Ta emot något icke godkänt eller prövningsmedel avsett för behandling av fibros i IPF
- Tidigare administrering av bexotegrast
- Kommer sannolikt att få lungtransplantation under studien (att stå på transplantationslistan är inte ett undantag)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Placebo
|
Placebo
|
|
Experimentell: Bexotegrast (PLN-74809) 160 mg Dos
Bexotegrast (PLN-74809) 160 mg Dos - 52 veckor
|
PLN-74809
|
|
Experimentell: Bexotegrast (PLN-74809) 320 mg Dos
Bexotegrast (PLN-74809) 320 mg Dos - 52 veckor
|
PLN-74809
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity at Week 52
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 november 2023
Primärt slutförande (Faktisk)
4 april 2025
Avslutad studie (Faktisk)
4 april 2025
Studieregistreringsdatum
Först inskickad
18 oktober 2023
Först inskickad som uppfyllde QC-kriterierna
18 oktober 2023
Första postat (Faktisk)
24 oktober 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PLN-74809-IPF-206
- BEACON-IPF (Annan identifierare: Pliant Therapeutics Inc)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .