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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2024-01-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2:1 randomization PLN-74809:placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

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PLN-74809

160 mg PLN-74809

Group Type EXPERIMENTAL

PLN-74809

Intervention Type DRUG

160 mg PLN-74809

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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PLN-74809

160 mg PLN-74809

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No