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Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Recruiting
Trial ID: NCT04396756
Purpose
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)
Stanford Investigator(s)
Joshua Mooney
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
Eligibility
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 & 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
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
Intervention(s):
drug: PLN-74809
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305