Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
NCT ID: NCT06097260
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
320 participants
INTERVENTIONAL
2023-11-16
2025-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Placebo
Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
PLN-74809
PLN-74809
Bexotegrast (PLN-74809) 320 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
PLN-74809
PLN-74809
Interventions
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PLN-74809
PLN-74809
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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Pliant Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pliant Therapeutics Medical Monitor
Role: STUDY_DIRECTOR
Pliant Therapeutics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
Dignity Health-St. Josephs Hospital and Medical Center
Phoenix, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Newport Native MD, Inc
Newport Beach, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Paradigm Clinical Research Institute Inc - ClinEdge
Redding, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCSF Medical Center - Pulmonary Practice
San Francisco, California, United States
Jeffrey S. Sager, MD Medical Corporation
Santa Barbara, California, United States
Stanford Health Care
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
National Jewish Health Main Campus
Denver, Colorado, United States
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
Danbury, Connecticut, United States
Yale New Haven Hospital - York Street Campus
New Haven, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Malcom Randall VA Medical Center
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Clinical Research Specialists, LLC
Kissimmee, Florida, United States
Clinical Site Partners - Leesburg
Leesburg, Florida, United States
Central Florida Pulmonary Group PA
Orlando, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
IU Health Advanced Heart and Lung Care
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lexington VA Medical Center
Lexington, Kentucky, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
The Johns Hopkins Hospital JHH
Baltimore, Maryland, United States
Massachusetts General Hospital - Pulmonary Associates
Boston, Massachusetts, United States
Brigham and Womans Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Cente
Boston, Massachusetts, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
The Lung Research Center
Chesterfield, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Montefiore Medical Center Moses Division Hospital
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
PulmonIx, LLC
Greensboro, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
OU Health Physicians
Oklahoma City, Oklahoma, United States
Bend Memorial Clinic/Summit Medical Group - Eastside
Bend, Oregon, United States
Legacy Good Samaritan Hospital
Portland, Oregon, United States
Clinical Research Associates Of Central PA , LLC
DuBois, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Velocity Clinical Research
Greenville, South Carolina, United States
Lowcountry Lung and Critical Care PA
North Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
Statcare Pulmonary Consultants - Knoxville
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott and White Health - Advanced Lung Disease Specialists
Dallas, Texas, United States
El Paso Pulmonary Association
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Research Centers of America
McKinney, Texas, United States
Renovatio Clinical Research
The Woodlands, Texas, United States
Topline Clinical Research
Waxahachie, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
INOVA Fairfax Medical Campus
Falls Church, Virginia, United States
Western Washington Medical Group
Everett, Washington, United States
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Instituto Ave Pulmo
Mar del Plata, Buenos Aires, Argentina
Clinica Privada Independencia
Munro, Buenos Aires, Argentina
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina
CEMER - Centro Medico de Enfermedades Respiratorias
Vicente López, Buenos Aires, Argentina
Centro de Investigacion Clinica-CEDIC
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Centro Médico Dra de Salvo
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
Rosario, Santa Fe Province, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Sanatorio Parque de Rosario
Rosario, Santa Fe Province, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, Tucumán Province, Argentina
Consultorios Médicos Organización de Buen Ayre SRL
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Medicina Respiratoria
Córdoba, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
INSARES
Mendoza, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Lung Research Qld
Chermside, Queensland, Australia
Respiratory Clinical Trials
Kent Town, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
TrialsWest
Spearwood, Western Australia, Australia
Institute for Respiratory Health - Midland
Midland, , Australia
AZ Delta
Roeselare, West-Vlaanderen, Belgium
UZ Leuvan
Leuven, , Belgium
Hospital Cardio Pulmonar
Salvador, Estado de Bahia, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre HCPA - PPDS
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
Kelowna Respirology and Allergy Research
Kelowna, British Columbia, Canada
Pacific Lung Research Center
Vancouver, British Columbia, Canada
Dynamic Drug Advancement
Ajax, Ontario, Canada
CIC Joliette
Saint-Charles-Borromée, Quebec, Canada
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada
CENRESIN
Quillota, , Chile
Av. Providencia 1208 oficina 209
Santiago, , Chile
CIMER - Centro de Investigaciones Medicas Respiratorias
Santiago, , Chile
CEC SpA
Santiago, , Chile
Biocinetic
Santiago, , Chile
Centro de Investigacion del Maule
Talca, , Chile
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
The second Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Fakultni Nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice Brno
Brno, South Moravian, Czechia
Fakultni Thomayerova Nemocnice
Prague, , Czechia
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Aarhus Universitetshospital
Aarhus, , Denmark
Aarhus Universitetshospital
Aarhus, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Odense Universitetshospital
Odense, , Denmark
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Institut Coeur Poumon - CHU de Lille
Lille, Nord, France
Hôpital Avicenne
Bobigny, Seine Saint Denis, France
CHU de Bordeaux- Hopital du Haut Lévêque
Bordeaux, , France
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Lyon, , France
Hôpital Nord - CHU Marseille
Marseille, , France
CHU Arnaud de Villeneuve
Montpellier, , France
CHU Nice - Hôpital Pasteur
Nice, , France
Hopital Pasteur CHU Nice
Nice, , France
Hospital Bretonneau
Paris, , France
Hôpital Bichat - Claude Bernard
Paris, , France
Hopital Haut-Leveque Pharmacie
Pessac, , France
CHU Reims - Hôpital Maison Blanche
Reims, , France
Hopital Larrey
Toulouse, , France
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Kliniken der Stadt Koln
Cologne, North Rhine-Westphalia, Germany
Ruhrlandklinik
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Evangelische Lungenklinik Berlin
Berlin, , Germany
Fachkrankenhaus Coswig GmbH
Coswig, , Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, , Germany
University General Hospital of Patras
Pátrai, Achaïa, Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, Attica, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
University General Hospital of Heraklion
Heraklion, , Greece
Unity Hospital ICU and Trauma
Surat, Gujarat, India
ESIC Medical College and Hospital
Faridabad, Haryana, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
BHS Lakeview Hospital
Belagavi, Karnataka, India
Bhatia Hospital
Mumbai, Maharashtra, India
Siddhi Hospital
Nashik, Maharashtra, India
J.L.N., Medical College and Attached Hospitals
Ajmer, Rajasthan, India
Asthma Bhavan
Jaipur, Rajasthan, India
Midland Healthcare & Research Center
Lucknow, Uttar Pradesh, India
Calcutta Medical Research Institute
Kolkata, West Bengal, India
B. P. Poddar Hospital and Medical Research Limited
Kolkata, West Bengal, India
Kaplan Medical Center
Rehovot, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Barzilai Medical Center
Ashkelon, Southern District, Israel
Tel Aviv Sourasky Medical Center
Ashkelon, Tel Aviv, Israel
Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Soroka University Medical Center
Beersheba, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Ospedale San Giuseppe Multimedica SpA
Milan, Milano, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
Foggia, , Italy
NHO Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Aso Co.,Ltd Iizuka Hospital
Iizuka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Hospital Organization
Kobe, Hyōgo, Japan
Center General Hospital
Kobe, Hyōgo, Japan
NHO Ibarakihigashi National Hospital
Naka-gun, Ibaraki, Japan
Tokushima University Hospital
Kawasaki-shi, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
NHO Kinki-Chuo Chest Medical Center
Osaka, Osaka, Japan
Saitama Prefectural Cardiovascular and Respiratory Center
Kumagaya-shi, Saitama, Japan
Saitama Red Cross Hospital
Saitama-shi, Saitama, Japan
Shimane University Hospital
Izumo-shi, Shimane, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan
Institute of Science Tokyo Hospital
Bunkyō City, Tokyo-To, Japan
Nippon Medical School Hospital
Bunkyō City, Tokyo-To, Japan
NHO Okinawa National Hospital
Hachioji-shi, Tokyo-To, Japan
Juntendo University Hospital
Minatoku, Tokyo-To, Japan
VU Medisch Centrum
Amsterdam, North Holland, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Greenlane Clinical Centre
Auckland, North Island, New Zealand
Dunedin Hospital
Dunedin, Otago, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship, Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
Lisbon, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, , Portugal
Inje University Busan Paik Hospital
Pusan, Gyeongsangnam-do, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Hanyang University Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, , Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Far Eastern Memorial Hospital
Taipei, , Taiwan
Royal Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom
Peterborough City Hospital
Peterborough, Cambridgeshire, United Kingdom
Altnagelvin Area Hospital
Londonderry, Derry, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Castle Hill Hospital
Cottingham, North Humberside, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Pinderfields General Hospital
Wakefield, West Yorkshire, United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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Related Links
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Trial website
Other Identifiers
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BEACON-IPF
Identifier Type: OTHER
Identifier Source: secondary_id
PLN-74809-IPF-206
Identifier Type: -
Identifier Source: org_study_id
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