Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

May 16, 2024 updated by: Pliant Therapeutics, Inc.

A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)

A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Four part study:

Part A - 4 week treatment period evaluating PLN-74809 or matching placebo

Part B - 12 week treatment period evaluating PLN-74809 or matching placebo

Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8X 5A6
        • Dr. Anil Dhar Medicine Professional Corporation
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie Centre
  • Italy
      • Milan, Italy, 20123
        • San Giuseppe Hospital, Multimedica S.p.a.
  • Netherlands
    • EJ
      • Eindhoven, EJ, Netherlands, 5623
        • Catharina Ziekenhuis
    • SZ
      • Nijmegen, SZ, Netherlands, 6532
        • Canisius-Wilhelmina Ziekenhuis
  • New Zealand
      • Christchurch, New Zealand, 8011
        • University of Otago Christchurch
    • Auckland
      • Greenlane, Auckland, New Zealand, 1051
        • New Zealand Respiratory and Sleep institute
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates, PA
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University Scool of Medicine/ Yale New Haven Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Missouri
      • Chesterfield, Missouri, United States, 63017-3625
        • Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • PulmonIx
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Lung Institute at One Hundred Oaks
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C & D)
  • FVC % of predicted ≥45%
  • DLco (hemoglobin-adjusted) ≥30%
  • Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo
Drug: Placebo
Placebo
Experimental: PLN-74809 Dose Level 1 (Part A)
PLN-74809 Dose Level 1 (Part A) - 4 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 Dose Level 2 (Part A)
PLN-74809 Dose Level 2 (Part A) - 4 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 Dose Level 2 (Part B)
PLN-74809 Dose Level 2 (Part B) - 12 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 - Dose Level 3 (Part C)
PLN-74809 Dose Level 3 (Part C) - 12 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 - Dose Level 4 (Part C)
PLN-74809 Dose Level 4 (Part C) - 12 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 - Dose Level 5 (Part D)
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
Drug: PLN-74809
PLN-74809

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A - Number of Participants With Treatment-Emergent Adverse Events
Time Frame: Up to 4 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Up to 4 weeks
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
Time Frame: Up to 12 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Up to 12 weeks
Part D - Number of Participants With Treatment-Emergent Adverse Events
Time Frame: Up to 48 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Up to 48 weeks
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
Time Frame: Up to 4 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Up to 4 weeks
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
Time Frame: Up to 12 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Up to 12 weeks
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
Time Frame: Up to 48 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Up to 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A - Assessment of PLN-74809 Total Plasma Concentrations
Time Frame: Week 4, 1 Hour Post Dose
Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose
Week 4, 1 Hour Post Dose
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
Time Frame: Week 12, 2 Hours Post Dose
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
Week 12, 2 Hours Post Dose
Part D - Assessment of PLN-74809 Total Plasma Concentrations
Time Frame: Week 24, 2 Hours Post Dose
Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
Week 24, 2 Hours Post Dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
Time Frame: Up to 12 weeks
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12.
Up to 12 weeks
Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
Time Frame: Up to 24 weeks
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24.
Up to 24 weeks
Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12
Time Frame: Up to 12 weeks
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Up to 12 weeks
Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24
Time Frame: Up to 24 weeks
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Up to 24 weeks
Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
Time Frame: Up to 12 weeks
Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.
Up to 12 weeks
Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
Time Frame: Up to 24 weeks
Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pliant Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLN-74809-IPF-202
  • INTEGRIS-IPF (Other Identifier: Pliant Therapeutics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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