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

Idiopathic Pulmonary Fibrosis Clinical Trial

— PLN-74809  

Official title:

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621252
• Other study ID #: PLN-74809-IPF-205
• Status: Completed
• Phase: Phase 2
• Start date: July 13, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: February 2024
• Source: Pliant Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period. Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 8, 2024
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• PLN-74809
160 mg PLN-74809
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pliant Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory 1	Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry	12 weeks
Other	Exploratory 2	Patient-reported outcome (PRO): Cough Severity Visual Analog Scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from "no cough" (0mm) to "worst cough" (100mm). Higher score means worse outcome.	12 weeks
Primary	Primary Outcome	Number of participants with a change in Baseline of type 1 collagen in the lung following 12 weeks of treatment with PLN-74809, as assessed by changes from Baseline in 68Ga-CBP8 (PET)/(MRI) tracer uptake patterns	12 weeks
Secondary	Secondary Safety and Tolerability	Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.	From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose