Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

• Status: Recruiting
• Trial end date: 2023-10-05
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Pliant Therapeutics, Inc.

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