Back to resultsImaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809) (PLN-74809)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PLN-74809
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PLN-74809
Placebo
Arm Description
160 mg PLN-74809
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Secondary Safety and Tolerability
Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.
Full Information
NCT ID
NCT05621252
First Posted
November 2, 2022
Last Updated
July 27, 2023
Sponsor
Pliant Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05621252
Brief Title
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
October 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pliant Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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; 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
8 participants will be receive PLN-74809 and 4 participants will receive placebo
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PLN-74809
Arm Type
Experimental
Arm Description
160 mg PLN-74809
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PLN-74809
Intervention Description
160 mg PLN-74809
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Primary Outcome
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Secondary Safety and Tolerability
Description
Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.
Time Frame
From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose
Other Pre-specified Outcome Measures:
Title
Exploratory 1
Description
Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry
Time Frame
12 weeks
Title
Exploratory 2
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Fromson
Phone
617-643-3260
Email
cfromson@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney Montesi, MD
Organizational Affiliation
Mass. General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Fromson
Phone
617-643-3260
Email
CFROMSON@MGH.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Sydney Montesi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
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