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Completed

NCT Number: NCT04396756

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLN-74809

Drug

PLN-74809

Placebo

Drug

Placebo

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Pliant Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 21, 2020
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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