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Pliant / PLN-74809-IPF-202

Condition: Idiopathic pulmonary fibrosis

Eligibility

Key Inclusion Criteria:

  • At least 40 years old
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) for up to 5 years before screening
  • FVC (pulmonary function test) percent of predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening

Key Exclusion Criteria:

  • Receiving any nonapproved agent intended for treatment of fibrosis in IPF
  • Forced expiratory volume during the first second over the FVC ratio <0.7 at screening
  • Clinical evidence of active infection that can affect FVC measurement during screening or at randomization

Study Name:

A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Phase IIa Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (INTEGRIS-IPF) (IRB no. 00000996)

Summary

This study focuses on individuals who have been diagnosed with idiopathic pulmonary fibrosis (IPF), a condition in which the air sacs in the lungs become damaged and lead to build-up of scar tissue (called fibrosis). The purpose of the study is to determine the safety and tolerability of an investigational drug called PLN-74809 compared to a placebo (inactive substance). Researchers will also evaluate how the body processes PLN-74809, as well as any changes in the participant’s condition.
 
Participants will be randomly assigned to one of two treatment groups. One group will receive 40 mg PLN-74809 once a day, and the other will receive a placebo, also once a day.
Principal Investigator
Contact

Pulmonary Research Team

Phone: 310-423-8474
Email: grouplungresearch@cshs.org