Phase 2
Completed N=120
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov NCT04396756 ↗Enrolled (actual)
120
Serious AEs
6.6%
Results posted
Apr 2024
Primary outcomePrimary: Part A - Number of Participants With Treatment-Emergent Adverse Events — 1 Participants
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.
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 | — |
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
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. Informational only — not medical advice.