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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pliant Therapeutics, Inc.
• Collaborator: Stanford University

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