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

Sponsored by Pliant Therapeutics, Inc.

About this trial

Last updated 2 years ago

Study ID

PLN-74809-IPF-205

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
40+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting