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Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

Phase 2
Completed
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Drug: Placebo
Registration Number
NCT05621252
Lead Sponsor
Pliant Therapeutics, Inc.
Brief Summary

This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.

Detailed Description

This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.

Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Participants, aged 40 years or older
  • Diagnosis of IPF, within 8 years prior to Screening
  • FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
  • Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
  • Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PLN-74809PLN-74809160 mg PLN-74809
PlaceboPlaceboPlacebo
Primary Outcome Measures
NameTimeMethod
Primary Outcome12 weeks

Change in Baseline in top quartile whole lung standardized uptake value following 12 weeks of treatment with PLN-74809. A negative change from baseline is a positive outcome and represents a decrease in measured collagen in the lung, a positive change from baseline is a negative outcome and represents an increase in measured collagen in the lung.

Secondary Outcome Measures
NameTimeMethod
Secondary Safety and TolerabilityFrom screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.

Trial Locations

Locations (1)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States

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