Trials Today

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

≥ 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

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

Arm	Description	Assigned 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

Arizona Pulmonary Specialists
Phoenix, Arizona 85012

The Cleveland Clinic Foundation
Cleveland, Ohio 44195

University of Utah
Salt Lake City, Utah 84108

Research Centers of America
McKinney, Texas 75071

Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas 75069

El Paso Pulmonary Association
El Paso, Texas 79902

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

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

Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104

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

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

OU Health Physicians
Oklahoma City, Oklahoma 73104

Southeastern Research Center
Winston-Salem, North Carolina 27103

Palmtree Clinical Research
Palm Springs, California 92262

IU Health Advanced Heart and Lung Care
Indianapolis, Indiana 46202

Paradigm Clinical Research Institute Inc - ClinEdge
Redding, California 96001

National Jewish Health Main Campus
Denver, Colorado 80206

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

Clinical Site Partners - Leesburg
Leesburg, Florida 34738

Central Florida Pulmonary Group PA
Orlando, Florida 32803

Northwestern Memorial Hospital
Chicago, Illinois 60611

University of Kansas Medical Center
Kansas City, Kansas 66160

PulmonIx, LLC
Greensboro, North Carolina 27403

Norton Pulmonary Specialists
Louisville, Kentucky 40202

Infinity Medical Research
North Dartmouth, Massachusetts 02747

University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota 55455

The Lung Research Center
Chesterfield, Missouri 63017

Creighton University
Omaha, Nebraska 68124

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.