A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF

PLN-74809-IPF-201

A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.

2020-02-13

2022-06-27

2022-07-05

Completed

Early phase I

9

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open label, incomplete crossover, up to 2 single doses administered at two different times', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

2023-12-12