Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

Pliant Therapeutics

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: PLN-74809; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04396756

INTEGRIS-IPF (Other Identifier)

PLN-74809-IPF-202

Details and patient eligibility

About

A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Full description

Four part study:

Part A - 4 week treatment period evaluating PLN-74809 or matching placebo

Part B - 12 week treatment period evaluating PLN-74809 or matching placebo

Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

Enrollment: 120 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C & D)
• FVC % of predicted ≥45%
• DLco (hemoglobin-adjusted) ≥30%
• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 7 patient groups

Placebo

Experimental group

Description:

Placebo

Treatment:

Drug: Placebo

PLN-74809 Dose Level 1 (Part A)

Experimental group

Description:

PLN-74809 Dose Level 1 (Part A) - 4 weeks

Treatment:

Drug: PLN-74809

PLN-74809 Dose Level 2 (Part A)

Experimental group

Description:

PLN-74809 Dose Level 2 (Part A) - 4 weeks

Treatment:

Drug: PLN-74809

PLN-74809 Dose Level 2 (Part B)

Experimental group

Description:

PLN-74809 Dose Level 2 (Part B) - 12 weeks

Treatment:

Drug: PLN-74809

PLN-74809 - Dose Level 3 (Part C)

Experimental group

Description:

PLN-74809 Dose Level 3 (Part C) - 12 weeks

Treatment:

Drug: PLN-74809

PLN-74809 - Dose Level 4 (Part C)

Experimental group

Description:

PLN-74809 Dose Level 4 (Part C) - 12 weeks

Treatment:

Drug: PLN-74809

PLN-74809 - Dose Level 5 (Part D)

Experimental group

Description:

PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks

Treatment:

Drug: PLN-74809