Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809) (PLN-74809)
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ClinicalTrials.gov Identifier: NCT05621252 |
Recruitment Status :
Completed
First Posted : November 18, 2022
Last Update Posted : February 9, 2024
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Condition or disease | Intervention/treatment | Phase |
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Idiopathic Pulmonary Fibrosis | Drug: PLN-74809 Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 2:1 randomization PLN-74809:placebo |
Masking: | Double (Participant, Investigator) |
Masking Description: | double-blind |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 13, 2022 |
Actual Primary Completion Date : | December 27, 2023 |
Actual Study Completion Date : | January 8, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: PLN-74809
160 mg PLN-74809
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Drug: PLN-74809
160 mg PLN-74809 |
Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Matching placebo |
- Primary Outcome [ Time Frame: 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 Safety and Tolerability [ Time Frame: 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.
- Exploratory 1 [ Time Frame: 12 weeks ]Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry
- Exploratory 2 [ Time Frame: 12 weeks ]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.
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05621252
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Sydney Montesi, MD | Mass. General Hospital |
Responsible Party: | Pliant Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT05621252 |
Other Study ID Numbers: |
PLN-74809-IPF-205 |
First Posted: | November 18, 2022 Key Record Dates |
Last Update Posted: | February 9, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases |