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

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: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: PLN-74809

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 (Estimated): 360
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pliant Therapeutics Medical Monitor; Phone Number: clintrials@pliantrx.com; Email: clintrials@pliantrx.com

Study Locations

• Australia
  • Midland, Australia, 6056
    • Recruiting
    • Institute for Respiratory Health - Midland
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Royal Prince Alfred Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Recruiting
      • Lung Research Qld
  • South Australia
    • Kent Town, South Australia, Australia, 5067
      • Recruiting
      • Respiratory Clinical Trials
    • Woodville South, South Australia, Australia, 5011
      • Not yet recruiting
      • The Queen Elizabeth Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6050
      • Not yet recruiting
      • Fiona Stanley Hospital
    • Spearwood, Western Australia, Australia, 6163
      • Recruiting
      • TrialsWest
• Canada
  • British Colombia
    • Kelowna, British Colombia, Canada, V1Y 3H5
      • Not yet recruiting
      • Kelowna Respirology and Allergy Research
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Not yet recruiting
      • Pacific Lung Research Center
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Recruiting
      • Dynamic Drug Advancement
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Not yet recruiting
      • Centre intégré de santé et de services sociaux (CISSS) de la Montérégie-Centre
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • Recruiting
      • Centre d'investigation Clinique Mauricie
• Chile
  • Santiago, Chile, 8330336
    • Recruiting
    • Biocinetic
  • Santiago, Chile, 7750495
    • Recruiting
    • CEC SpA
• Czechia
  • Praha 4, Czechia, 140 00
    • Not yet recruiting
    • Fakultni Thomayerova Nemocnice
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 625 00
      • Not yet recruiting
      • Fakultni nemocnice Brno
  • Olomoucký Kraj
    • Olomouc, Olomoucký Kraj, Czechia, 779 00
      • Not yet recruiting
      • Fakultni nemocnice Olomouc
• Denmark
  • Aarhus, Denmark, 8200
    • Not yet recruiting
    • Aarhus Universitetshospital
  • Hellerup, Denmark, 2900
    • Not yet recruiting
    • Gentofte Hospital
  • South Denmark
    • Odense, South Denmark, Denmark, 5000
      • Not yet recruiting
      • Odense Universitetshospital
• France
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35000
      • Not yet recruiting
      • Hôpital Pontchaillou
• Germany
  • Berlin, Germany, 13125
    • Not yet recruiting
    • Evangelische Lungenklinik Berlin
  • Bayern
    • München, Bayern, Germany, 81377
      • Not yet recruiting
      • LMU Klinikum der Universität München - Campus Großhadern
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Not yet recruiting
      • Universitätsklinikum Gießen (UKGM)
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Not yet recruiting
      • Medizinische Hochschule Hannover
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45239
      • Not yet recruiting
      • Ruhrlandklinik
    • Köln, Nordrhein-Westfalen, Germany, 51109
      • Not yet recruiting
      • Kliniken der Stadt Koln
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Not yet recruiting
      • Krankenhaus Bethanien
  • Sachsen
    • Coswig, Sachsen, Germany, 01640
      • Not yet recruiting
      • Fachkrankenhaus Coswig
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Not yet recruiting
      • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Thüringen
    • Bad Berka, Thüringen, Germany, 99438
      • Not yet recruiting
      • Zentralklinik Bad Berka
• Greece
  • Achaïa
    • Patras, Achaïa, Greece, 265 04
      • Not yet recruiting
      • University General Hospital of Patras
  • Attiki
    • Athens, Attiki, Greece, 115 27
      • Not yet recruiting
      • Sotiria Thoracic Diseases Hospital of Athens
  • Evros
    • Alexandroupoli, Evros, Greece, 681 00
      • Not yet recruiting
      • University General Hospital of Alexandroupolis
  • Ioannina
    • Ioánnina, Ioannina, Greece, 455 00
      • Not yet recruiting
      • University General Hospital of Ioannina
• Israel
  • Haifa, Israel, 34362
    • Not yet recruiting
    • Lady Davis Carmel Medical Center
  • Haifa, Israel, 34980
    • Not yet recruiting
    • Rambam Medical Center
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center
  • HaDarom
    • Ashkelon, HaDarom, Israel, 7830604
      • Recruiting
      • Barzilai Medical Center
  • HaMerkaz
    • Reẖovot, HaMerkaz, Israel, 76100
      • Not yet recruiting
      • Kaplan Medical Center
  • Tel-Aviv
    • Ashkelon, Tel-Aviv, Israel, 78278
      • Recruiting
      • Tel Aviv Sourasky Medical Center
    • Ramat Gan, Tel-Aviv, Israel, 52394
      • Not yet recruiting
      • Sheba Medical Center
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91031
      • Recruiting
      • Shaare Zedek Medical Center
• Italy
  • Roma, Italy, 00168
    • Not yet recruiting
    • Policlinico Universitario Fondazione Agostino Gemelli - Roma
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Recruiting
    • Inje University Haeundae Paik Hospital
  • Gyeongsangnamdo
    • Busan, Gyeongsangnamdo, Korea, Republic of, 50834
      • Recruiting
      • Inje University Busan Paik Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
      • Not yet recruiting
      • Korea University Anam Hospital
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
      • Recruiting
      • Hanyang University Medical Center
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Not yet recruiting
      • VU Medisch Centrum
• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Recruiting
      • Christchurch Hospital
  • North Island
    • Auckland, North Island, New Zealand, 1051
      • Recruiting
      • Greenlane Clinical Centre
  • Otago
    • Dunedin, Otago, New Zealand, 9016
      • Recruiting
      • Dunedin Hospital
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • Recruiting
      • Waikato Hospital
• Poland
  • Lubuskie
    • Nowa Sól, Lubuskie, Poland, 67-100
      • Not yet recruiting
      • Twoja Przychodnia NCM
• Portugal
  • Braga, Portugal, 4710-243
    • Not yet recruiting
    • Hospital de Braga
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Not yet recruiting
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 11217
    • Not yet recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10002
    • Not yet recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 220
    • Not yet recruiting
    • Far Eastern Memorial Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Not yet recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Recruiting
      • Arizona Pulmonary Specialists
    • Tucson, Arizona, United States, 85724
      • Not yet recruiting
      • University of Arizona College of Medicine
  • California
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Not yet recruiting
      • University of Southern California - Keck School of Medicine
    • Palm Springs, California, United States, 92262
      • Recruiting
      • Palmtree Clinical Research
    • Palo Alto, California, United States, 94304
      • Not yet recruiting
      • VA Palo Alto Health Care System
    • Redding, California, United States, 96001
      • Recruiting
      • Paradigm Clinical Research Institute Inc - ClinEdge
    • Sacramento, California, United States, 95807
      • Not yet recruiting
      • University of California Davis Comprehensive Cancer Center
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • UCSF Medical Center - Pulmonary Practice
    • Santa Barbara, California, United States, 93105
      • Not yet recruiting
      • Jeffrey S. Sager, MD Medical Corporation
  • Colorado
    • Aurora, Colorado, United States, 80048
      • Not yet recruiting
      • University of Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health Main Campus
    • Lakewood, Colorado, United States, 80228
      • Not yet recruiting
      • Critical Care, Pulmonary and Sleep Associates
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Not yet recruiting
      • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital - York Street Campus
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Not yet recruiting
      • MedStar Georgetown University Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • Not yet recruiting
      • Malcom Randall VA Medical Center
    • Leesburg, Florida, United States, 34738
      • Recruiting
      • Clinical Site Partners - Leesburg
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Central Florida Pulmonary Group PA
    • Tampa, Florida, United States, 33609
      • Not yet recruiting
      • GCP Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory Clinic
    • Augusta, Georgia, United States, 30912
      • Not yet recruiting
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Not yet recruiting
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Advanced Heart and Lung Care
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • Not yet recruiting
      • Lexington VA Medical Center
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Pulmonary Specialists
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Not yet recruiting
      • Tulane Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital - Pulmonary Associates
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Brigham and Womans Hospital
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Cente
    • North Dartmouth, Massachusetts, United States, 02747
      • Recruiting
      • Infinity Medical Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Medical Center, Fairview
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • The Lung Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Recruiting
      • Creighton University
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Not yet recruiting
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Weill Cornell Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27403
      • Recruiting
      • PulmonIx, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Not yet recruiting
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • OU Health Physicians
  • Oregon
    • Bend, Oregon, United States, 97701
      • Recruiting
      • Bend Memorial Clinic/Summit Medical Group - Eastside
    • Portland, Oregon, United States, 97232
      • Not yet recruiting
      • Legacy Good Samaritan Hospital
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Recruiting
      • Clinical Research Associates Of Central PA , LLC
    • Hershey, Pennsylvania, United States, 17033
      • Not yet recruiting
      • Penn State Health Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Perelman Center for Advanced Medicine
    • Pittsburgh, Pennsylvania, United States, 15213
      • Not yet recruiting
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Recruiting
      • Lowcountry Lung and Critical Care PA
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Recruiting
      • Clinical Trials Center of Middle Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Recruiting
      • Statcare Pulmonary Consultants - Knoxville
    • Nashville, Tennessee, United States, 37204
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott and White Health - Advanced Lung Disease Specialists
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Pulmonary Association
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Baylor College of Medicine
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Metroplex Pulmonary and Sleep Medicine Center
    • McKinney, Texas, United States, 75071
      • Recruiting
      • Research Centers of America
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Not yet recruiting
      • University of Vermont Medical Center
  • Washington
    • Everett, Washington, United States, 98208
      • Recruiting
      • Western Washington Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in absolute FVC (mL)	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to disease progression	Time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), respiratory-related hospitalization, or all cause mortality through Week 52	Up to 52 weeks
Change from baseline in absolute FVC (mL) at Week 52	In participants on background therapy at baseline; In participants not on background therapy at baseline	52 weeks
Proportion of participants with treatment-emergent adverse events and serious adverse events		Up to 54 weeks
Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality		Up to 52 weeks
Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)		52 Weeks
Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52		Up to 52 weeks
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score	The Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. Domain and total scores range from 0 to 100, with higher scores indicating greater impairment.	52 Weeks
Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score	The KBILD(King's Brief Interstitial Lung Disease Questionnaire) is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale.1 It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status	52 Weeks
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment	Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)	52 Weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Trial website

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 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 (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: idiopathic pulmonary fibrosis; IPF; pulmonary fibrosis; Beacon; bexotegrast; BEACON-IPF
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• 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