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

Prior treatment

• Receiving pharmacologic therapy for pulmonary 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)
• Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening

Other illness

• 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
• Uncontrolled systemic arterial hypertension
• Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization

Other

• Self-reported smoking of any kind (not limited to tobacco)
• Pregnant or lactating female participant
• Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening

• ≥ 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