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

Sponsored by Pliant Therapeutics, Inc.

About this trial

Last updated 3 years ago

Study ID

PLN-74809-IPF-201

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
40+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

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

- 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