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

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: PLN-74809; Drug: Placebo

• Registration Number: NCT05621252
• Lead Sponsor: Pliant Therapeutics, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-18
• Primary Completion: 2023-12-27
• Study Completion: 2024-01-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLN-74809	PLN-74809	160 mg PLN-74809
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Primary Outcome	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Secondary Safety and Tolerability	From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose	Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States