Phase 2
N=9
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04072315 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. — 1; 1; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PLN-74809 (Drug); Knottin tracer (Radiation)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pliant Therapeutics, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. |
1; 1; 0; 2; 1; 1 | — |
| SECONDARY Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events |
0; 0; 1; 0; 0; 1 | — |
Summary
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of IPF, within 5 years prior to Screening,
- FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
- DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
- 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
- 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 (NCT04072315). 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.