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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT06097260

Run by

Pliant Therapeutics, Inc.

People needed

320

Starts

2023-11-16

Expected to finish

2025-04-04

Last updated by the study team

2026-08-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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
• 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

Where it is running

• 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 — New Port 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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