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

Purpose

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.

Condition

Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages: Over 40 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Placebo	Placebo	Drug: Placebo Placebo
Experimental PLN-74809 Dose Level 1 (Part A)	PLN-74809 Dose Level 1 (Part A) - 4 weeks	Drug: PLN-74809 PLN-74809
Experimental PLN-74809 Dose Level 2 (Part A)	PLN-74809 Dose Level 2 (Part A) - 4 weeks	Drug: PLN-74809 PLN-74809
Experimental PLN-74809 Dose Level 2 (Part B)	PLN-74809 Dose Level 2 (Part B) - 12 weeks	Drug: PLN-74809 PLN-74809
Experimental PLN-74809 - Dose Level 3 (Part C)	PLN-74809 Dose Level 3 (Part C) - 12 weeks	Drug: PLN-74809 PLN-74809
Experimental PLN-74809 - Dose Level 4 (Part C)	PLN-74809 Dose Level 4 (Part C) - 12 weeks	Drug: PLN-74809 PLN-74809
Experimental PLN-74809 - Dose Level 5 (Part D)	PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks	Drug: PLN-74809 PLN-74809

Recruiting Locations

More Details

NCT ID: NCT04396756
Status: Completed
Sponsor: Pliant Therapeutics, Inc.

Detailed 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.