Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pliant Therapeutics, Inc.
Four 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 intermediatery PLN-74809 doses or matching placebo
Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \& D)
FVC % of 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
You may not be if
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
Clareo Health | Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
