PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF).
- Study Sponsor: Pliant Therapeutics, Inc.
- Start Date: March 2020
- Estimated Primary Completion Date: December 2021
- Phase 2a, multicenter, 3-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF)
- Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B & C)
- FVC %predicted ≥45%
- DLco (hemoglobin-adjusted) ≥30%
- Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
- 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