Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pliant Therapeutics, Inc.

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