AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 2NCT06097260

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

A Phase 2 study testing PLN-74809 in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 268 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
PLN-74809
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
268 sitesin 25 countries
Study dates
16 Nov 2023to 4 Apr 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

268 sites in 25 countries.

268 sites in 25 countries

United States79 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80048

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • The Johns Hopkins Hospital JHH

    Baltimore, Maryland, 21224

  • Bend Memorial Clinic/Summit Medical Group - Eastside

    Bend, Oregon, 97701

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital - Pulmonary Associates

    Boston, Massachusetts, 02114

  • Brigham and Womans Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts, 02215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung Research Center

    Chesterfield, Missouri, 63017

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor Scott and White Health - Advanced Lung Disease Specialists

    Dallas, Texas, 75246

  • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists

    Danbury, Connecticut, 06810

  • National Jewish Health Main Campus

    Denver, Colorado, 80206

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Clinical Research Associates Of Central PA , LLC

    DuBois, Pennsylvania, 15801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • Western Washington Medical Group

    Everett, Washington, 98208

  • INOVA Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608

  • PulmonIx, LLC

    Greensboro, North Carolina, 27403

  • Velocity Clinical Research

    Greenville, South Carolina, 29615

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • IU Health Advanced Heart and Lung Care

    Indianapolis, Indiana, 46202

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Research Specialists, LLC

    Kissimmee, Florida, 34746

  • Statcare Pulmonary Consultants - Knoxville

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Clinical Site Partners - Leesburg

    Leesburg, Florida, 34738

  • Lexington VA Medical Center

    Lexington, Kentucky, 40508

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Research Centers of America

    McKinney, Texas, 75071

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

  • Yale New Haven Hospital - York Street Campus

    New Haven, Connecticut, 06510

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Newport Native MD, Inc

    New Port Beach, California, 92663

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10032

  • Lowcountry Lung and Critical Care PA

    North Charleston, South Carolina, 29406

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747

  • OU Health Physicians

    Oklahoma City, Oklahoma, 73104

  • Central Florida Pulmonary Group PA

    Orlando, Florida, 32803

  • Palmtree Clinical Research

    Palm Springs, California, 92262

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Arizona Pulmonary Specialists

    Phoenix, Arizona, 85012

  • Dignity Health-St. Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Legacy Good Samaritan Hospital

    Portland, Oregon, 97232

  • Paradigm Clinical Research Institute Inc - ClinEdge

    Redding, California, 96001

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95807

  • University of Utah

    Salt Lake City, Utah, 84108

  • UCSF Medical Center - Pulmonary Practice

    San Francisco, California, 94143

  • Jeffrey S. Sager, MD Medical Corporation

    Santa Barbara, California, 93105

  • Stanford Health Care

    Stanford, California, 94305

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Montefiore Medical Center Moses Division Hospital

    The Bronx, New York, 10467

  • Renovatio Clinical Research

    The Woodlands, Texas, 77380

  • Banner University Medical Center

    Tucson, Arizona, 85724

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Topline Clinical Research

    Waxahachie, Texas, 75165

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan23 sites

  • Institute of Science Tokyo Hospital

    Bunkyō City, Tokyo-To, 113-8519

  • Nippon Medical School Hospital

    Bunkyō City, Tokyo-To, 113-8603

  • NHO Kyushu Medical Center

    Fukuoka, Fukuoka, 810-0066

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • NHO Okinawa National Hospital

    Hachioji-shi, Tokyo-To, 192-0081

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 732-0827

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka-shi, Fukuoka, 820-8505

  • Shimane University Hospital

    Izumo-shi, Shimane, 693-8501

  • Tokushima University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556

  • Kobe City Hospital Organization

    Kobe, Hyōgo, 650-0047

  • Center General Hospital

    Kobe, Hyōgo, 6500047

  • Saitama Prefectural Cardiovascular and Respiratory Center

    Kumagaya-shi, Saitama, 360-0197

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Juntendo University Hospital

    Minatoku, Tokyo-To, 105-0023

  • NHO Ibarakihigashi National Hospital

    Naka-gun, Ibaraki, 319-1113

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • NHO Kinki-Chuo Chest Medical Center

    Osaka, Osaka, 591-8555

  • Saitama Red Cross Hospital

    Saitama-shi, Saitama, 330-8553

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-0001

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

China17 sites

  • The second Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230061

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The 3rd Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50051

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Argentina16 sites

  • Consultorios Médicos Organización de Buen Ayre SRL

    Buenos Aires, Buenos Aires F.D., C1425FVH

  • Centro de Investigacion Clinica-CEDIC

    Buenos Aires, Ciudad Autonoma Buenos Aires, 1060

  • Centro Médico Dra de Salvo

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, 1280

  • Instituto de Medicina Respiratoria

    Córdoba, X5003DCE

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Instituto Ave Pulmo

    Mar del Plata, Buenos Aires, B7600DCK

  • Fundacion Scherbovsky

    Mendoza, Mendoza Province, M5500AXR

  • INSARES

    Mendoza, Mendoza Province, M5500CCG

  • Clinica Privada Independencia

    Munro, Buenos Aires, B1605FRE

  • Centro Respiratorio Quilmes

    Quilmes, Buenos Aires, B1878FNR

  • Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

    Rosario, Santa Fe Province, 2000

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe Province, S2000DEJ

  • Sanatorio Parque de Rosario

    Rosario, Santa Fe Province, S2000DSV

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, Tucumán Province, T4000CBC

  • CEMER - Centro Medico de Enfermedades Respiratorias

    Vicente López, Buenos Aires, 1602

Other trials in Argentina

France14 sites

  • Hôpital Avicenne

    Bobigny, Seine St Denis, 93000

  • CHU de Bordeaux- Hopital du Haut Lévêque

    Bordeaux

  • Institut Coeur Poumon - CHU de Lille

    Lille, Nord, 59037

  • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

    Lyon

  • Hôpital Nord - CHU Marseille

    Marseille

  • CHU Arnaud de Villeneuve

    Montpellier

  • CHU Nice - Hôpital Pasteur

    Nice

  • Hopital Pasteur CHU Nice

    Nice

  • Hospital Bretonneau

    Paris

  • Hôpital Bichat - Claude Bernard

    Paris

  • Hopital Haut-Leveque Pharmacie

    Pessac

  • CHU Reims - Hôpital Maison Blanche

    Reims

  • Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35000

  • Hopital Larrey

    Toulouse

Other trials in France

Australia11 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Lung Research Qld

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Austin Health

    Heidelberg, Victoria, 3084

  • Respiratory Clinical Trials

    Kent Town, South Australia, 5067

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Institute for Respiratory Health - Midland

    Midland, 6056

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6050

  • TrialsWest

    Spearwood, Western Australia, 6163

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

India11 sites

  • J.L.N., Medical College and Attached Hospitals

    Ajmer, Rajasthan, 305001

  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

  • BHS Lakeview Hospital

    Belagavi, Karnataka, 590016

  • ESIC Medical College and Hospital

    Faridabad, Haryana, 121001

  • Asthma Bhavan

    Jaipur, Rajasthan, 302023

  • Calcutta Medical Research Institute

    Kolkata, West Bengal, 700027

  • B. P. Poddar Hospital and Medical Research Limited

    Kolkata, West Bengal, 700053

  • Midland Healthcare & Research Center

    Lucknow, Uttar Pradesh, 226006

  • Bhatia Hospital

    Mumbai, Maharashtra, 400007

  • Siddhi Hospital

    Nashik, Maharashtra, 422007

  • Unity Hospital ICU and Trauma

    Surat, Gujarat, 395010

Other trials in India

Germany10 sites

  • Evangelische Lungenklinik Berlin

    Berlin, State of Berlin, 13125

  • Kliniken der Stadt Koln

    Cologne, North Rhine-Westphalia, 51109

  • Fachkrankenhaus Coswig GmbH

    Coswig, 01640

  • Ruhrlandklinik

    Essen, North Rhine-Westphalia, 45239

  • IKF Pneumologie GmbH &amp; Co. KG

    Frankfurt

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum des Saarlandes

    Homburg

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Leipzig AoeR

    Leipzig

  • LMU Klinikum der Universität München - Campus Großhadern

    München, Bavaria, 81377

Other trials in Germany

Israel10 sites

  • Barzilai Medical Center

    Ashkelon, Southern District, 7830604

  • Tel Aviv Sourasky Medical Center

    Ashkelon, Tel Aviv, 78278

  • Soroka University Medical Center

    Beersheba, 84001

  • Lady Davis Carmel Medical Center

    Haifa, Haifa District, 34362

  • Rambam Medical Center

    Haifa, 34980

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, Tel Aviv, 52394

  • Kaplan Medical Center

    Rehovot, Central District, 76100

Other trials in Israel

United Kingdom9 sites

  • Birmingham Heartlands Hospital

    Birmingham, Birmingham, B9 5SS

  • Royal Papworth Hospital

    Cambridge, Cambridgeshire, CB2 0AY

  • Castle Hill Hospital

    Cottingham, North Humberside, HU16 5JQ

  • Royal Brompton Hospital

    London, London, SW3 6NP

  • Altnagelvin Area Hospital

    Londonderry, Derry, BT47 6SB

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

  • Peterborough City Hospital

    Peterborough, Cambridgeshire, PE3 9GZ

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Pinderfields General Hospital

    Wakefield, West Yorkshire, WF1 4DG

Other trials in United Kingdom

Brazil8 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, Rio Grande do Sul, 99010-120

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91010-006

  • Hospital de Clinicas de Porto Alegre HCPA - PPDS

    Porto Alegre, 90410-001

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000

  • Hospital Cardio Pulmonar

    Salvador, Estado de Bahia, 40170310

Other trials in Brazil

Chile6 sites

  • CENRESIN

    Quillota, 2260734

  • Av. Providencia 1208 oficina 209

    Santiago, 7500571

  • CIMER - Centro de Investigaciones Medicas Respiratorias

    Santiago, 7500657

  • CEC SpA

    Santiago, 7750495

  • Biocinetic

    Santiago, 8330336

  • Centro de Investigacion del Maule

    Talca, 3481349

Other trials in Chile

South Korea6 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Inje University Busan Paik Hospital

    Pusan, Gyeongsangnam-do, 50834

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi, 02841

  • Hanyang University Medical Center

    Seoul, Seoul Teugbyeolsi, 04763

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Taiwan6 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Far Eastern Memorial Hospital

    Taipei, 220

Other trials in Taiwan

Canada5 sites

  • Dynamic Drug Advancement

    Ajax, Ontario, L1S 2J5

  • Kelowna Respirology and Allergy Research

    Kelowna, British Columbia, V1Y 3H5

  • CIC Joliette

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Centre d'investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T 7A1

  • Pacific Lung Research Center

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Denmark5 sites

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Aarhus Universitetshospital

    Aarhus

  • Gentofte Hospital

    Hellerup, 2900

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

  • Odense Universitetshospital

    Odense

Other trials in Denmark

Italy5 sites

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Alessandria, 15121

  • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Bergamo, 24127

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Firenze, 50134

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia

    Foggia, Foggia, 71122

  • Ospedale San Giuseppe Multimedica SpA

    Milan, Milano, 20123

Other trials in Italy

Spain5 sites

  • Hospital Universitari de Bellvitge

    Barcelona, Barcelona, 08907

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Greece4 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, Evros, 681 00

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, Attica, 115 27

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University General Hospital of Patras

    Pátrai, Achaïa, 265 04

Other trials in Greece

New Zealand4 sites

  • Greenlane Clinical Centre

    Auckland, North Island, 1051

  • Christchurch Hospital

    Christchurch, Canterbury, 8013

  • Dunedin Hospital

    Dunedin, Otago, 9016

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Poland4 sites

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Twoja Przychodnia NCM

    Nowa Sól, Lubusz Voivodeship, 67-100

Other trials in Poland

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, South Moravian, 625 00

  • Fakultni Nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

  • Fakultni Thomayerova Nemocnice

    Prague, 140 00

Other trials in Czechia

Portugal3 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta

    Lisbon, Portugal, 1169-024

  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Belgium2 sites

  • UZ Leuvan

    Leuven, 3000

  • AZ Delta

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Netherlands2 sites

  • VU Medisch Centrum

    Amsterdam, North Holland, 1081 HV

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
PLN-74809, Placebo
Keywords
IPF, idiopathic pulmonary fibrosis, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF
Medical subject headings
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLN-74809Drug

    PLN-74809

  • PlaceboDrug

    Placebo

Study groups in NCT06097260
Study groupRoleWhat they receive
PlaceboExperimentalPlacebo
Receives: Drug: Placebo
Bexotegrast (PLN-74809) 160 mg DoseExperimentalBexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Receives: Drug: PLN-74809
Bexotegrast (PLN-74809) 320 mg DoseExperimentalBexotegrast (PLN-74809) 320 mg Dose - 52 weeks
Receives: Drug: PLN-74809

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Forced Vital Capacity at 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).

    Measured: Baseline (Day 1) and Week 52

Secondary outcomes (8)

  1. Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at 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.

    Measured: Baseline (Day 1) and Week 52

  2. Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at 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.

    Measured: Baseline (Day 1) and Week 52

  3. Number of Participants With an Event of Disease Progression

    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.

    Measured: Baseline (Day 1) and up to Week 52

  4. Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at 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.

    Measured: Baseline (Day 1) and Week 52

  5. Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through 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.

    Measured: Baseline (Day 1) and up to Week 52

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    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.

    Measured: From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days

  7. Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at 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).

    Measured: Baseline (Day 1) and Week 52

  8. Number of Participants With Disease Progression for Hazard Ratio

    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.

    Measured: Baseline (Day 1) and up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start16 Nov 2023
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Why it stopped: DSMB recommendation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097260
Sponsor's protocol ID
PLN-74809-IPF-206
Other IDs
BEACON-IPF
Status last verified
Jun 2026
First submitted
18 Oct 2023
Last updated
5 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wuyts WA, Lancaster L, Maher TM, Ryerson CJ, Kreuter M, Corte TJ, Valenzuela C, Barnes CN, Lefebvre EA, Cosgrove GP, Flaherty KR, Richeldi L, Cottin V. Bexotegrast for treatment of idiopathic pulmonary fibrosis (BEACON-IPF): study protocol for a multinational, phase 2b/3, double-blind, randomised, multicentre, controlled trial. BMJ Open Respir Res. 2026 Mar 10;13(1):e002937. doi: 10.1136/bmjresp-2024-002937.

    PubMed 41807015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLN-74809 in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 268 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Japan, China, Argentina, France and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Forced Vital Capacity at Week 52 (time frame: Baseline (Day 1) and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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