Imaging Evaluation of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis

The purpose of this study is to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks.

  • Study Sponsor: Pliant Therapeutics, Inc.

  • Start Date: July 2022

  • Estimated Primary Completion Date: October 2023

  • Single-center, phase 2a, randomized, double-blind, placebo-controlled, evaluation of PLN-74809 on type 1 collagen deposition using 68Ga-CBP8 PET/MRI imaging in participants with idiopathic pulmonary fibrosis (IPF)

Primary Outcome Measure:

  • Number of participants with a change in Baseline of type 1 collagen in the lung following 12 weeks of treatment with PLN-74809, as assessed by changes from Baseline in 68Ga-CBP8 (PET)/(MRI) tracer uptake patterns [Time Frame: 12 weeks]

Inclusion Criteria:

  • Participants, aged 40 years or older
  • Diagnosis of IPF, within 8 years prior to Screening
  • FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
  • Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
  • Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, if on a stable dose for at least 3 months

Exclusion Criteria:

  • Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
  • Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7 at Screening
  • Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
  • Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
  • Smoking of any kind within 3 months of Screening

Participating Clinics at Partner ILD Centers