Phase IIA
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
- Study HIC#:2000027545
- Last Updated:04/05/2022
A Phase 2a, multicenter, 3-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.
- Age40 years and older
- GenderBoth
- Start Date03/30/2022
- End Date03/31/2022
Trial Purpose and Description
Three part study:
Part A - 4 week treatment period evaluating PLN-74809 or matching placebo
Part B - 12 week treatment period evaluating PLN-74809 or matching placebo
Part C - 12 week treatment period evaluating up to two higher PLN-74809 dose cohorts or matching placebo
Eligibility Criteria
Inclusion Criteria:
- 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
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
