Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

July 29, 2025 updated by: Pliant Therapeutics, Inc.

A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).

The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Argentina, C1425FVH
        • Consultorios Medicos Organizacion de Buen Ayre SRL
      • Córdoba, Argentina, X5003DCE
        • Instituto de Medicina Respiratoria
      • Mendoza, Argentina, M5500CCG
        • INSARES
      • Mendoza, Argentina, M5500AXR
        • Fundación Scherbovsky
    • Buenos Aires
      • Mar Del Plata, Buenos Aires, Argentina, B7600DCK
        • Instituto Ave Pulmo
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Medicas Mar del Plata
      • 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
    • Ciudad Autonoma Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1060
        • Centro de Investigacion Clinica-CEDIC
    • Ciudad Autónoma De BuenosAires
      • Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1426ABP
        • Centro Médico Dra de Salvo
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque de Rosario
    • Tucumán
      • San Miguel De Tucumán, Tucumán, 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
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuvan
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta
  • Brazil
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brazil, 90410-001
        • Hospital de Clinicas de Porto Alegre HCPA - PPDS
    • Bahia
      • Salvador, Bahia, Brazil, 40170310
        • Hospital Cardio Pulmonar
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericórdia de Belo Horizonte
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
        • Instituto Mederi de Pesquisa e Saude
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
        • Hospital Ernesto Dornelles
      • Porto Alegre, Rio Grande Do Sul, Brazil, 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-Borromee, Quebec, Canada, J6E 2B4
        • CIC Joliette
      • Trois-Rivieres, 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 Investigación del Maule
  • China
    • Anhui
      • Hefei, Anhui, China, 230061
        • The Second Hospital of Anhui Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510163
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 50051
        • The 3rd Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, China, 450000
        • Henan Provincial Chest Hospital
    • Hubei
      • Yichang, Hubei, China, 443000
        • Yichang Central People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • The Second Xiangya Hospital Of Central South University
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital
  • Czechia
      • Praha 4, Czechia, 140 00
        • Fakultni Thomayerova nemocnice
    • Jihomoravský Kraj
      • Brno, Jihomoravský Kraj, Czechia, 625 00
        • Fakultní nemocnice Brno
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • Fakultni nemocnice Olomouc
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital
      • Aarhus, Denmark
        • Aarhus Universitetshospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Odense, Denmark
        • Odense Universitetshospital
    • South Denmark
      • Odense, South Denmark, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Bordeaux, France
        • CHU de Bordeaux- Hopital du Haut Lévêque
      • Lyon, France
        • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
      • Marseille, France
        • Hopital Nord - CHU Marseille
      • Montpellier, France
        • CHU Arnaud de Villeneuve
      • Nice, France
        • CHU Nice - Hôpital Pasteur
      • Nice, France
        • Hopital Pasteur CHU Nice
      • Paris, France
        • Hôpital Bichat - Claude Bernard
      • Paris, France
        • Hospital Bretonneau
      • Pessac, France
        • Hopital Haut-Leveque Pharmacie
      • Reims, France
        • CHU Reims - Hôpital Maison Blanche
      • Toulouse, France
        • Hôpital Larrey
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Hôpital Pontchaillou
    • Nord
      • Lille Cedex, Nord, France, 59037
        • Institut Coeur Poumon - CHU de Lille
    • Seine Saint Denis
      • Bobigny, Seine Saint Denis, France, 93000
        • Hopital Avicenne
  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig GmbH
      • Frankfurt, Germany
        • IKF Pneumologie GmbH & Co. KG
      • Homburg, Germany
        • Universitaetsklinikum des Saarlandes
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig Aoer
    • Bayern
      • München, Bayern, Germany, 81377
        • LMU Klinikum der Universität München - Campus Grosshadern
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45239
        • Ruhrlandklinik
      • Köln, Nordrhein-Westfalen, Germany, 51109
        • Kliniken der Stadt Köln
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Greece
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion
    • Achaïa
      • Patras, Achaïa, Greece, 265 04
        • University General Hospital of Patras
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Sotiria Thoracic Diseases Hospital of Athens
    • Evros
      • Alexandroupoli, Evros, Greece, 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
      • Belgaum, Karnataka, India, 590010
        • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
      • Belgaum, 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
      • Beer-Sheva, Israel, 84001
        • Soroka university medical center
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Haifa, Israel, 34980
        • Rambam Medical Center
      • Kfar-Saba, Israel, 4428164
        • Meir Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
    • HaDarom
      • Ashkelon, HaDarom, Israel, 7830604
        • Barzilai Medical Center
    • HaMerkaz
      • Reẖovot, HaMerkaz, Israel, 76100
        • Kaplan Medical Center
    • Tel-Aviv
      • Ashkelon, Tel-Aviv, Israel, 78278
        • Tel Aviv Sourasky Medical Center
      • Ramat Gan, Tel-Aviv, Israel, 52394
        • Sheba Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91031
        • Shaare Zedek Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Foggia, Italy, 71122
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
    • Milano
      • Milan, Milano, Italy, 20123
        • Ospedale San Giuseppe Multimedica SpA
  • Japan
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-0066
        • NHO Kyushu Medical Center
      • Iizuka-shi, Fukuoka-Ken, Japan, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Kitakyushu-shi, Fukuoka-Ken, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
    • Fukushima-Ken
      • Fukushima-shi, Fukushima-Ken, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Hiroshima-Ken
      • Hiroshima-shi, Hiroshima-Ken, Japan, 732-0827
        • Hiroshima Prefectural Hospital
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0001
        • Sapporo Medical University Hospital
    • Hyogo-Ken
      • Kobe-shi, Hyogo-Ken, Japan, 650-0047
        • Kobe City Hospital Organization
      • Kobe-shi, Hyogo-Ken, Japan, 6500047
        • Center General Hospital
    • Ibaraki-Ken
      • Naka-gun, Ibaraki-Ken, Japan, 319-1113
        • NHO Ibarakihigashi National Hospital
    • Kanagawa-Ken
      • Kawasaki-shi, Kanagawa-Ken, Japan, 216-8511
        • Tokushima University Hospital
      • Yokohama-shi, Kanagawa-Ken, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
    • Kumamoto-Ken
      • Kumamoto-shi, Kumamoto-Ken, Japan, 860-8556
        • Kumamoto University Hospital
    • Okayama-Ken
      • Okayama-shi, Okayama-Ken, Japan, 700-8558
        • Okayama University Hospital
    • Osaka-Fu
      • Osaka-shi, Osaka-Fu, Japan, 591-8555
        • NHO Kinki-Chuo Chest Medical Center
    • Saitama-Ken
      • Kumagaya-shi, Saitama-Ken, Japan, 360-0197
        • Saitama Prefectural Cardiovascular and Respiratory Center
      • Saitama-shi, Saitama-Ken, Japan, 330-8553
        • Saitama Red Cross Hospital
    • Shimane-Ken
      • Izumo-shi, Shimane-Ken, Japan, 693-8501
        • Shimane University Hospital
    • Shizuoka-Ken
      • Hamamatsu-shi, Shizuoka-Ken, Japan, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-8603
        • Nippon Medical School Hospital
      • Bunkyo-ku, Tokyo-To, Japan, 113-8519
        • Institute of Science Tokyo Hospital
      • Hachioji-shi, Tokyo-To, Japan, 192-0081
        • NHO Okinawa National Hospital
      • Minato-Ku, Tokyo-To, Japan, 105-0023
        • Juntendo University Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Gyeongsangnamdo
      • Busan, Gyeongsangnamdo, Korea, Republic of, 50834
        • Inje University Busan Paik Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Hanyang University Medical Center
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VU Medisch Centrum
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands
        • St. Antonius Ziekenhuis
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8013
        • Christchurch Hospital
    • North Island
      • Auckland, North Island, New Zealand, 1051
        • Greenlane Clinical Centre
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Dunedin Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
        • Waikato Hospital
  • Poland
      • Bydgoszcz, Poland
        • Vitamed Galaj I Cichomski sp.j.
      • Gdańsk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Kraków, Poland, 30-688
        • Sp Zoz Szpital Uniwersytecki W Krakowie
    • Lubuskie
      • Nowa Sól, Lubuskie, Poland, 67-100
        • Twoja Przychodnia NCM
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisbon, Portugal, 1169-024
        • Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Málaga, Spain
        • Hospital Clinico Universitario Virgen de la Victoria
      • Santiago De Compostela, Spain, 15706
        • CHUS - H. Clinico U. de Santiago
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
  • 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
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Royal Papworth Hospital
      • Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
    • Derry
      • Londonderry, Derry, United Kingdom, BT47 6SB
        • Altnagelvin Area Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • North Humberside
      • Cottingham, North Humberside, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Churchill Hospital
    • West Yorkshire
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Pinderfields General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialists
      • Phoenix, Arizona, United States, 85013
        • Dignity Health-St. Josephs Hospital and Medical Center
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Newport Beach, California, United States, 92663
        • Newport Native MD, Inc
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • Redding, California, United States, 96001
        • Paradigm Clinical Research Institute Inc - ClinEdge
      • Sacramento, California, United States, 95807
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, United States, 94143
        • UCSF Medical Center - Pulmonary Practice
      • Santa Barbara, California, United States, 93105
        • Jeffrey S. Sager, MD Medical Corporation
      • Stanford, California, United States, 94305
        • Stanford Health Care
    • Colorado
      • Aurora, Colorado, United States, 80048
        • University of Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health Main Campus
      • Lakewood, Colorado, United States, 80228
        • Critical Care, Pulmonary and Sleep Associates
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital - York Street Campus
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Kissimmee, Florida, United States, 34746
        • Clinical Research Specialists, LLC
      • Leesburg, Florida, United States, 34738
        • Clinical Site Partners - Leesburg
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group PA
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Advanced Heart and Lung Care
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Lexington VA Medical Center
      • Louisville, Kentucky, United States, 40202
        • Norton Pulmonary Specialists
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21224
        • The Johns Hopkins Hospital JHH
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Cente
      • Boston, Massachusetts, United States, 02115
        • Brigham and Womans Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Pulmonary Associates
      • North Dartmouth, Massachusetts, United States, 02747
        • Infinity Medical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Lung Research Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center Moses Division Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital-Columbia University Medical Center
      • New York, New York, United States, 10032
        • Weill Cornell Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27403
        • Pulmonix, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Physicians
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic/Summit Medical Group - Eastside
      • Portland, Oregon, United States, 97232
        • Legacy Good Samaritan Hospital
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates Of Central Pa , Llc
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29615
        • Velocity Clinical Research
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Lung and Critical Care PA
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Trials Center of Middle Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Knoxville, Tennessee, United States, 37909
        • Statcare Pulmonary Consultants - Knoxville
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White Health - Advanced Lung Disease Specialists
      • El Paso, Texas, United States, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • McKinney, Texas, United States, 75071
        • Research Centers of America
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical Research
      • Waxahachie, Texas, United States, 75165
        • Topline Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
    • Washington
      • Everett, Washington, United States, 98208
        • Western Washington Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 40 years of age prior to screening
  2. IPF diagnosis ≤ 7 years prior to screening
  3. FVCpp ≥ 45%
  4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
  5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
  6. If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening

Exclusion Criteria:

  1. Receiving pharmacologic therapy for pulmonary hypertension
  2. Self-reported smoking of any kind (not limited to tobacco)
  3. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
  4. Hepatic impairment or end-stage liver disease
  5. Renal impairment or end-stage kidney disease requiring dialysis
  6. Pregnant or lactating female participant
  7. Uncontrolled systemic arterial hypertension
  8. Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
  9. Prior administration of bexotegrast
  10. Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
  11. Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
  12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
  13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
Placebo
Experimental: Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Drug: PLN-74809
PLN-74809
Experimental: Bexotegrast (PLN-74809) 320 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
Drug: PLN-74809
PLN-74809

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF)
Time Frame: 52 weeks
Change from baseline in absolute FVC (mL) at Week 52
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score
Time Frame: 52 Weeks
The Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. Domain and total scores range from 0 to 100, with higher scores indicating greater impairment.
52 Weeks
Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score
Time Frame: 52 Weeks
The KBILD(King's Brief Interstitial Lung Disease Questionnaire) is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale.1 It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status
52 Weeks
To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression
Time Frame: Up to 52 weeks
• Time to disease progression, 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 through Week 52
Up to 52 weeks
Time to disease progression defined as
Time Frame: Up to 52 weeks
Time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52
Up to 52 weeks
Proportion of participants with disease progression defined as
Time Frame: Up to 52 weeks
Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52
Up to 52 weeks
To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF
Time Frame: 52 weeks

Change from baseline in absolute FVC (mL) at Week 52

  • In participants on background therapy at baseline
  • In participants not on background therapy at baseline
52 weeks
To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography
Time Frame: 52 Weeks
Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)
52 Weeks
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF
Time Frame: Up to 52 weeks
Proportion of participants with treatment-emergent adverse events and serious adverse events
Up to 52 weeks
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment
Time Frame: Over 52 Weeks
Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)
Over 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pliant Therapeutics, Inc.

Investigators

  • Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

April 4, 2025

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLN-74809-IPF-206
  • BEACON-IPF (Other Identifier: Pliant Therapeutics Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe