Phase 2 N=120 Randomized Quadruple-blind Treatment

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

Idiopathic Pulmonary Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT04396756 ↗

Enrolled (actual)

120

Serious AEs

6.6%

Results posted

Apr 2024

Primary outcome: Primary: Part A - Number of Participants With Treatment-Emergent Adverse Events — 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PLN-74809 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pliant Therapeutics, Inc.
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A - Number of Participants With Treatment-Emergent Adverse Events	1	—
PRIMARY Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events	16; 15; 14; 17; 21	—
PRIMARY Part D - Number of Participants With Treatment-Emergent Adverse Events	20; 7	—
PRIMARY Part A - Number of Participants With Serious Treatment-Emergent Adverse Events	—	—
PRIMARY Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events	1; 0; 2; 1; 3	—
PRIMARY Part D - Number of Participants With Serious Treatment-Emergent Adverse Events	2; 1	—
SECONDARY Part A - Assessment of PLN-74809 Total Plasma Concentrations	829	—
SECONDARY Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations	921.45; 1731.70; 2733.71; 3742.78	—
SECONDARY Part D - Assessment of PLN-74809 Total Plasma Concentrations	4120.63	—

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.

Eligibility 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 & 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04396756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.