Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
August 3, 2026 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
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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
- Clinica 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 Britanico 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 Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion 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, Australia, 6056
- Institute for Respiratory Health - Midland
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside, Queensland, Australia, 4032
- Lung Research Qld
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South Australia
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Kent Town, South Australia, Australia, 5067
- Respiratory Clinical Trials
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Woodville South, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Heidelberg, Victoria, Australia, 3084
- Austin Health
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6050
- Fiona Stanley Hospital
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Spearwood, Western Australia, Australia, 6163
- Trialswest
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Leuven, Belgium, 3000
- UZ Leuvan
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgium, 8800
- AZ Delta
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Porto Alegre, Brazil, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Brazil, 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, Brazil, 40170310
- Hospital Cardio Pulmonar
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 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, Brazil, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
- Hospital Ernesto Dornelles
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Porto Alegre, Rio Grande do Sul, Brazil, 91010-006
- Hospital Nossa Senhora da Conceicao
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 3H5
- Kelowna Respirology and Allergy Research
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Pacific Lung Research Center
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Dynamic Drug Advancement
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Quebec
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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
- CIC Joliette
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Centre d'investigation Clinique Mauricie
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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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Anhui
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Hefei, Anhui, China, 230061
- The Second Hospital of Anhui Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Nanfang Hospital of Southern Medical University
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Guangzhou, Guangdong, China, 510163
- The First Affiliated Hospital of Guangzhou Medical University
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Hebei
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Shijiazhuang, Hebei, China, 50051
- The 3rd Hospital of Hebei Medical University
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Henan
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Zhengzhou, Henan, China, 450003
- Henan Provincial People's Hospital
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Zhengzhou, Henan, China, 450000
- Henan Provincial Chest Hospital
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Hubei
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Yichang, Hubei, China, 443000
- Yichang Central People's Hospital
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Hunan
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Changsha, Hunan, China, 410008
- The second Xiangya hospital of central south university
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Jiangsu
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Wuxi, Jiangsu, China, 214023
- Wuxi People's Hospital
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Xuzhou, Jiangsu, China, 221006
- The Affiliated Hospital of Xuzhou Medical College
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Jiangxi
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Nanchang, Jiangxi, China, 330209
- The First Affiliated Hospital Of Nanchang University
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Liaoning
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Shenyang, Liaoning, China, 110004
- Shengjing Hospital of China Medical University
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, China, 610072
- Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300052
- Tianjin Medical University General Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- Hangzhou First People's Hospital
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Prague, Czechia, 140 00
- Fakultni Thomayerova nemocnice
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Olomouc Region
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Olomouc, Olomouc Region, Czechia, 779 00
- Fakultni nemocnice Olomouc
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South Moravian
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Brno, South Moravian, Czechia, 625 00
- Fakultní Nemocnice Brno
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Aarhus, Denmark, 8200
- Aarhus Universitetshospital
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Aarhus, Denmark
- Aarhus Universitetshospital
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Hellerup, Denmark, 2900
- Gentofte Hospital
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Odense, Denmark
- Odense Universitetshospital
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Region Syddanmark
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Odense, Region Syddanmark, Denmark, 5000
- Odense Universitetshospital
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Bordeaux, France
- CHU de Bordeaux- Hopital du Haut Lévêque
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Lyon, France
- CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
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Marseille, France
- Hopital Nord - CHU Marseille
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Montpellier, France
- CHU Arnaud de Villeneuve
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Nice, France
- CHU Nice - Hôpital Pasteur
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Nice, France
- Hopital Pasteur CHU Nice
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Paris, France
- Hôpital Bichat - Claude Bernard
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Paris, France
- Hospital Bretonneau
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Pessac, France
- Hopital Haut-Leveque Pharmacie
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Reims, France
- CHU Reims - Hôpital Maison Blanche
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Toulouse, France
- Hopital Larrey
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35000
- Hopital Pontchaillou
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Nord
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Lille, Nord, France, 59037
- Institut Coeur Poumon - CHU de Lille
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Seine St Denis
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Bobigny, Seine St Denis, France, 93000
- Hopital Avicenne
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Coswig, Germany, 01640
- Fachkrankenhaus Coswig GmbH
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Frankfurt, Germany
- IKF Pneumologie GmbH & Co. KG
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Homburg, Germany
- Universitaetsklinikum des Saarlandes
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Leipzig, Germany
- Universitaetsklinikum Leipzig AoeR
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Bavaria
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München, Bavaria, Germany, 81377
- LMU Klinikum der Universität München - Campus Großhadern
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30625
- Medizinische Hochschule Hannover
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Germany, 51109
- Kliniken der Stadt Köln
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Essen, North Rhine-Westphalia, Germany, 45239
- Ruhrlandklinik
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
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State of Berlin
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Berlin, State of Berlin, Germany, 13125
- Evangelische Lungenklinik Berlin
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Heraklion, Greece, 71110
- University General Hospital of Heraklion
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Achaïa
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Pátrai, Achaïa, Greece, 265 04
- University General Hospital of Patras
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Attica
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Athens, Attica, Greece, 115 27
- Sotiria Thoracic Diseases Hospital of Athens
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Evros
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Alexandroupoli, Evros, Greece, 681 00
- University General Hospital of Alexandroupolis
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Gujarat
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Surat, Gujarat, India, 395010
- Unity Hospital ICU and Trauma
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Haryana
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Faridabad, Haryana, India, 121001
- ESIC Medical College and Hospital
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Karnataka
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Belagavi, Karnataka, India, 590010
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
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Belagavi, Karnataka, India, 590016
- BHS Lakeview Hospital
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Maharashtra
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Mumbai, Maharashtra, India, 400007
- Bhatia Hospital
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Nashik, Maharashtra, India, 422007
- Siddhi Hospital
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Rajasthan
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Ajmer, Rajasthan, India, 305001
- J.L.N., Medical College and Attached Hospitals
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Jaipur, Rajasthan, India, 302023
- Asthma Bhavan
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226006
- Midland Healthcare & Research Center
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West Bengal
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Kolkata, West Bengal, India, 700027
- Calcutta Medical Research Institute
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Kolkata, West Bengal, India, 700053
- B. P. Poddar Hospital and Medical Research Limited
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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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Alessandria
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Alessandria, Alessandria, Italy, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
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Bergamo
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Bergamo, Bergamo, Italy, 24127
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
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Firenze
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Florence, Firenze, Italy, 50134
- Azienda Ospedaliera Universitaria Careggi
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Foggia
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Foggia, Foggia, Italy, 71122
- Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
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Milano
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Milan, Milano, Italy, 20123
- Ospedale San Giuseppe Multimedica SpA
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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
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Fukushima, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Hiroshima
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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
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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
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Ibaraki
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Naka-gun, Ibaraki, Japan, 319-1113
- NHO Ibarakihigashi National Hospital
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Kanagawa
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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
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Osaka
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Osaka, Osaka, Japan, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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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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North Holland
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Amsterdam, North Holland, Netherlands, 1081 HV
- VU Medisch Centrum
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Utrecht
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Nieuwegein, Utrecht, Netherlands
- St. Antonius Ziekenhuis
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Canterbury
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Christchurch, Canterbury, New Zealand, 8013
- Christchurch Hospital
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North Island
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Auckland, North Island, New Zealand, 1051
- Greenlane Clinical Centre
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Otago
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Dunedin, Otago, New Zealand, 9016
- Dunedin Hospital
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Waikato Region
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Hamilton, Waikato Region, New Zealand, 3204
- Waikato Hospital
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Bydgoszcz, Poland
- Vitamed Galaj i Cichomski sp.j.
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Gdansk, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne
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Krakow, Poland, 30-688
- SP ZOZ Szpital Uniwersytecki w Krakowie
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Poland, 67-100
- Twoja Przychodnia NCM
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Braga, Portugal, 4710-243
- Hospital de Braga
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Vila Nova de Gaia, Portugal, 4434-502
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
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Portugal
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Lisbon, Portugal, Portugal, 1169-024
- Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
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Busan, South Korea, 48108
- Inje University Haeundae Paik Hospital
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Gyeongsangnam-do
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Pusan, Gyeongsangnam-do, South Korea, 50834
- Inje University Busan Paik Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, South Korea, 02841
- Korea University Anam Hospital
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Seoul, Seoul Teugbyeolsi, South Korea, 04763
- Hanyang University Medical Center
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Majadahonda, Spain
- Hospital Universitario Puerta de Hierro Majadahonda
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Málaga, Spain
- Hospital Clinico Universitario Virgen de la Victoria
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Santiago de Compostela, Spain, 15706
- CHUS - H. Clinico U. de Santiago
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Barcelona
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Barcelona, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taichung, Taiwan
- Taichung Veterans General Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
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Birmingham
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Birmingham, Birmingham, United Kingdom, B9 5SS
- Birmingham Heartlands Hospital
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
- Royal Papworth Hospital
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Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
- Peterborough City Hospital
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Derry
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Londonderry, Derry, United Kingdom, BT47 6SB
- Altnagelvin Area Hospital
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Hampshire
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Southampton, Hampshire, United Kingdom, SO16 6YD
- Southampton General Hospital
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London
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London, London, United Kingdom, SW3 6NP
- Royal Brompton Hospital
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North Humberside
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Cottingham, North Humberside, United Kingdom, HU16 5JQ
- Castle Hill Hospital
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7LE
- Churchill Hospital
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West Yorkshire
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Wakefield, West Yorkshire, United Kingdom, WF1 4DG
- Pinderfields General Hospital
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, United States, 85012
- Arizona Pulmonary Specialists
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Phoenix, Arizona, United States, 85013
- Dignity Health-St. Josephs Hospital and Medical Center
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Tucson, Arizona, United States, 85724
- Banner University Medical Center
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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New Port Beach, California, United States, 92663
- Newport Native MD, Inc
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Palm Springs, California, United States, 92262
- Palmtree Clinical Research
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Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
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Redding, California, United States, 96001
- Paradigm Clinical Research Institute Inc - ClinEdge
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Sacramento, California, United States, 95807
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, United States, 94143
- UCSF Medical Center - Pulmonary Practice
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Santa Barbara, California, United States, 93105
- Jeffrey S. Sager, MD Medical Corporation
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Stanford, California, United States, 94305
- Stanford Health Care
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Colorado
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Aurora, Colorado, United States, 80048
- University of Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health Main Campus
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Lakewood, Colorado, United States, 80228
- Critical Care, Pulmonary and Sleep Associates
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Connecticut
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Danbury, Connecticut, United States, 06810
- Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
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New Haven, Connecticut, United States, 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, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Gainesville, Florida, United States, 32608
- Malcom Randall VA Medical Center
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
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Kissimmee, Florida, United States, 34746
- Clinical Research Specialists, LLC
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Leesburg, Florida, United States, 34738
- Clinical Site Partners - Leesburg
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Orlando, Florida, United States, 32803
- Central Florida Pulmonary Group PA
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Tampa, Florida, United States, 33609
- GCP Clinical Research
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory Clinic
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Augusta, Georgia, United States, 30912
- Augusta University
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health Advanced Heart and Lung Care
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40508
- Lexington VA Medical Center
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Louisville, Kentucky, United States, 40202
- Norton Pulmonary Specialists
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, United States, 21224
- The Johns Hopkins Hospital JHH
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Cente
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Boston, Massachusetts, United States, 02115
- Brigham and Womans Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital - Pulmonary Associates
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North Dartmouth, Massachusetts, United States, 02747
- Infinity Medical Research
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Michigan
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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
-
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
-
The Bronx, New York, United States, 10467
- Montefiore Medical Center Moses Division Hospital
-
-
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
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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
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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McKinney, Texas, United States, 75071
- Research Centers of America
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The Woodlands, Texas, United States, 77380
- Renovatio Clinical Research
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Waxahachie, Texas, United States, 75165
- Topline Clinical Research
-
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
-
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Medical Campus
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Washington
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Everett, Washington, United States, 98208
- Western Washington Medical Group
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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:
- ≥ 40 years of age prior to screening
- IPF diagnosis ≤ 7 years prior to screening
- FVCpp ≥ 45%
- Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
- Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
- 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:
- Receiving pharmacologic therapy for pulmonary hypertension
- Self-reported smoking of any kind (not limited to tobacco)
- 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
- Hepatic impairment or end-stage liver disease
- Renal impairment or end-stage kidney disease requiring dialysis
- Pregnant or lactating female participant
- Uncontrolled systemic arterial hypertension
- Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
- Prior administration of bexotegrast
- Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
- Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
- Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
- 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
|
Placebo
|
|
Experimental: Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
|
PLN-74809
|
|
Experimental: Bexotegrast (PLN-74809) 320 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
|
PLN-74809
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity at Week 52
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 5, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
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.