Phase 2
N=10
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05621252 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Primary Outcome — -0.0147; 0.0740 Unitless
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
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome |
-0.0147; 0.0740 | — |
| SECONDARY Secondary Safety and Tolerability |
6; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05621252). 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.