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

Purpose

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).

Condition

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Placebo 		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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

Clinical Research Associates Of Central PA , LLC
DuBois, Pennsylvania 15801

Mayo Clinic
Rochester, Minnesota

The Lung Research Center
Chesterfield, Missouri 63017

Creighton University
Omaha, Nebraska 68124

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Weill Cornell Medicine
New York, New York 10032

Duke University Medical Center
Durham, North Carolina 27710

PulmonIx, LLC
Greensboro, North Carolina 27403

Southeastern Research Center
Winston-Salem, North Carolina 27103

University of Cincinnati
Cincinnati, Ohio 45267

The Cleveland Clinic Foundation
Cleveland, Ohio 44195

OU Health Physicians
Oklahoma City, Oklahoma 73104

Bend Memorial Clinic/Summit Medical Group - Eastside
Bend, Oregon 97701

Legacy Good Samaritan Hospital
Portland, Oregon 97232

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033

Henry Ford Health System
Detroit, Michigan 48202

El Paso Pulmonary Association
El Paso, Texas 79902

University of Vermont Medical Center
Burlington, Vermont 05401

University of Utah
Salt Lake City, Utah 84108

Renovatio Clinical Research
The Woodlands, Texas

Research Centers of America
McKinney, Texas 75071

Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas 75069

Baylor College of Medicine
Houston, Texas 77030

Baylor Scott and White Health - Advanced Lung Disease Specialists
Dallas, Texas 75246

Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104

Vanderbilt University Medical Center
Nashville, Tennessee 37204

Statcare Pulmonary Consultants - Knoxville
Knoxville, Tennessee 37909

Clinical Trials Center of Middle Tennessee
Franklin, Tennessee 37067

Lowcountry Lung and Critical Care PA
North Charleston, South Carolina 29406

Medical University of South Carolina
Charleston, South Carolina 29425

University of Pittsburgh Medical Center
Pittsburg, Pennsylvania 15213

University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota 55455

University of Michigan Health System
Ann Arbor, Michigan 48109

Arizona Pulmonary Specialists
Phoenix, Arizona 85012

Malcom Randall VA Medical Center
Gainesville, Florida 32608

University of Arizona College of Medicine
Tucson, Arizona 85724

Cedars Sinai Medical Center
Los Angeles, California 90048

Newport Native MD, Inc
New Port beach, California 92663

Palmtree Clinical Research
Palm Springs, California 92262

VA Palo Alto Health Care System
Palo Alto, California 94304

Paradigm Clinical Research Institute Inc - ClinEdge
Redding, California 96001

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

University of Colorado
Aurora, Colorado 80048

National Jewish Health Main Campus
Denver, Colorado 80206

Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado 80228

Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
Danbury, Connecticut 06810

Yale New Haven Hospital - York Street Campus
New Haven, Connecticut 06510

Mayo Clinic Jacksonville
Jacksonville, Florida 32224

Infinity Medical Research
North Dartmouth, Massachusetts 02747

University of Kansas Medical Center
Kansas City, Kansas 66160

Beth Israel Deaconess Medical Cente
Boston, Massachusetts 02215

Brigham and Womans Hospital
Boston, Massachusetts 02115

University of Maryland Medical Center
Baltimore, Maryland 21201

Tulane Medical Center
New Orleans, Louisiana 70112

Norton Pulmonary Specialists
Louisville, Kentucky 40202

Lexington VA Medical Center
Lexington, Kentucky 40508

IU Health Advanced Heart and Lung Care
Indianapolis, Indiana 46202

Clinical Site Partners - Leesburg
Leesburg, Florida 34738

Loyola University Medical Center
Maywood, Illinois 60153

Northwestern Memorial Hospital
Chicago, Illinois 60611

Augusta University
Augusta, Georgia 30912

Emory Clinic
Atlanta, Georgia 30322

GCP Clinical Research
Tampa, Florida 33609

Central Florida Pulmonary Group PA
Orlando, Florida 32803

Western Washington Medical Group
Everett, Washington 98208

More Details

NCT ID
NCT06097260
Status
Recruiting
Sponsor
Pliant Therapeutics, Inc.

Study Contact

Pliant Therapeutics Medical Monitor
clintrials@pliantrx.com
clintrials@pliantrx.com

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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center