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