A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)

Inclusion Criteria:
Each participant must meet the following criteria to be enrolled in this study:
1. ≥ 40 years of age prior to screening
2. IPF diagnosis ≤ 7 years prior to screening based upon American Thoracic Society / European
Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association
2018 guidelines and confirmed with central review (Raghu et al 2018)
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
7. Estimated glomerular filtration rate ≥ 30 mL/min, according to the Cockcroft-Gault equation
8. Female participant of nonchildbearing potential must be surgically sterile or postmenopausal
9. Female participant of childbearing potential must use a contraceptive method with a failure rate
of < 1% per year or remain abstinent (refrain from heterosexual intercourse) during the
Treatment Period and for 4 weeks after the last dose of study drug(s)
10. Male participant with female partner of childbearing potential must agree to use contraceptive
measures or remain abstinent (refrain from heterosexual intercourse) during the Treatment
Period and for at least 12 weeks after the last dose of study drug(s)
11. Agree to abstain from sperm or egg donation for the duration of the study, through 12 weeks or
4 weeks, respectively, after administration of the last dose of study drug(s)
12. Understand the study procedures and agree to participate in the study by giving written
informed consent