This study is in progress, not accepting new patients

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

a study on Fibrosis Idiopathic Pulmonary Fibrosis

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

A Phase 2a, multicenter, 4-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.

Official Title

A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)

Details

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

Keywords

Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Fibrosis PLN-74809

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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 %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 CAN'T join 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

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pliant Therapeutics, Inc.
ID
NCT04396756
Phase
Phase 2 research study
Study Type
Interventional
Participants
At least 120 people participating
Last Updated