Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/ (IPF-201)

Pliant Therapeutics

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: PLN-74809; Radiation: Knottin tracer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04072315

PLN-74809-IPF-201

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 5 patient groups

PLN-74809 Dose Level 1 (60 mg)

Experimental group

Description:

PLN-74809 Dose Level 1 (60mg)

Treatment:

Drug: PLN-74809

Radiation: Knottin tracer

PLN-74809 Dose Level 2 (80 mg)

Experimental group

Description:

PLN-74809 Dose Level 2 (80 mg)

Treatment:

Drug: PLN-74809

Radiation: Knottin tracer

PLN-74809 Dose Level 3 (120 mg)

Experimental group

Description:

PLN-74809 Dose Level 3 (120 mg)

Treatment:

Drug: PLN-74809

Radiation: Knottin tracer

PLN-74809 Dose Level 4 (240 mg)

Experimental group

Description:

PLN-74809 Dose Level 4 (240 mg)

Treatment:

Drug: PLN-74809

Radiation: Knottin tracer

PLN-74809 Dose Level 4 (320 mg)

Experimental group

Description:

PLN-74809 Dose Level 4 (320 mg)

Treatment:

Drug: PLN-74809

Radiation: Knottin tracer