Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
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.
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
Interventions
DRUGPLN-74809
PLN-74809
DRUGPlacebo
Placebo
Sponsors
Pliant Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part D - Number of Participants With Serious Treatment-Emergent Adverse Events | 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. |
| Part A - Number of Participants With Treatment-Emergent Adverse Events | 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. |
| Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 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. |
| Part A - Number of Participants With Serious Treatment-Emergent Adverse Events | 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. |
| Part D - Number of Participants With Treatment-Emergent Adverse Events | 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. |
| Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations | Week 12, 2 Hours Post Dose | Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose |
| Part A - Assessment of PLN-74809 Total Plasma Concentrations | Week 4, 1 Hour Post Dose | Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose |
| Part D - Assessment of PLN-74809 Total Plasma Concentrations | Week 24, 2 Hours Post Dose | Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | Up to 12 weeks | Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12. |
| Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 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. |
| Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 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. |
| Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24 | Up to 24 weeks | Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic. |
| Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | Up to 12 weeks | Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic. |
| Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | Up to 24 weeks | Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24. |
Countries
Australia, Belgium, Canada, Italy, Netherlands, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PLN-74809 (Part A) - 40 mg PLN-74809 (Part A) - 40 mg PLN-74809 | 1 |
| PLN-74809 (Part B) - 40 mg PLN-74809 (Part B) - 40 mg PLN-74809 | 22 |
| PLN-74809 (Part C) - 80 mg PLN-74809 (Part C) - 80 mg PLN-74809 | 23 |
| PLN-74809 (Part C) - 160 mg PLN-74809 (Part C) - 160 mg PLN-74809 | 22 |
| PLN-74809 (Part D) - 320 mg PLN-74809 (Part D) - 320 mg PLN-74809 | 21 |
| Placebo Placebo (Part B, C, D) | 31 |
| Total | 120 |
Baseline characteristics
| Characteristic | PLN-74809 (Part A) - 40 mg | PLN-74809 (Part B) - 40 mg | PLN-74809 (Part C) - 80 mg | PLN-74809 (Part C) - 160 mg | PLN-74809 (Part D) - 320 mg | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 64 years | 69.2 years STANDARD_DEVIATION 7.11 | 74.2 years STANDARD_DEVIATION 4.7 | 71.5 years STANDARD_DEVIATION 6.63 | 70.6 years STANDARD_DEVIATION 7.31 | 72.1 years STANDARD_DEVIATION 6.2 | 71.4 years STANDARD_DEVIATION 6.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 21 Participants | 23 Participants | 22 Participants | 21 Participants | 31 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 1 Participants | 22 Participants | 21 Participants | 22 Participants | 20 Participants | 30 Participants | 116 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants | 6 Participants | 1 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 18 Participants | 19 Participants | 16 Participants | 20 Participants | 27 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 22 | 0 / 23 | 0 / 22 | 1 / 22 | 0 / 31 |
| other Total, other adverse events | 1 / 1 | 8 / 22 | 8 / 23 | 10 / 22 | 18 / 22 | 14 / 31 |
| serious Total, serious adverse events | 0 / 1 | 1 / 22 | 0 / 23 | 2 / 22 | 2 / 22 | 3 / 31 |
Outcome results
Primary
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
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.
Time frame: Up to 4 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part A - Number of Participants With Serious Treatment-Emergent Adverse Events | 0 Participants |
Primary
Part A - Number of Participants With Treatment-Emergent Adverse Events
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.
Time frame: Up to 4 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part A - Number of Participants With Treatment-Emergent Adverse Events | 1 Participants |
Primary
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
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.
Time frame: Up to 12 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 1 Participants |
| PLN-74809 (Part C) - 80 mg | Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 0 Participants |
| PLN-74809 (Part C) - 160 mg | Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 2 Participants |
| PLN-74809 (Part D) - 320 mg | Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 1 Participants |
| Placebo (Part B, C, D) | Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events | 3 Participants |
Primary
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
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.
Time frame: Up to 12 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 16 Participants |
| PLN-74809 (Part C) - 80 mg | Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 15 Participants |
| PLN-74809 (Part C) - 160 mg | Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 14 Participants |
| PLN-74809 (Part D) - 320 mg | Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 17 Participants |
| Placebo (Part B, C, D) | Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events | 21 Participants |
Primary
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
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.
Time frame: Up to 48 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Number of Participants With Serious Treatment-Emergent Adverse Events | 2 Participants |
| PLN-74809 (Part C) - 80 mg | Part D - Number of Participants With Serious Treatment-Emergent Adverse Events | 1 Participants |
Primary
Part D - Number of Participants With Treatment-Emergent Adverse Events
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.
Time frame: Up to 48 weeks
Population: Safety Population included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Number of Participants With Treatment-Emergent Adverse Events | 20 Participants |
| PLN-74809 (Part C) - 80 mg | Part D - Number of Participants With Treatment-Emergent Adverse Events | 7 Participants |
Secondary
Part A - Assessment of PLN-74809 Total Plasma Concentrations
Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose
Time frame: Week 4, 1 Hour Post Dose
Population: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part A - Assessment of PLN-74809 Total Plasma Concentrations | 829 ng/mL |
Secondary
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
Time frame: Week 12, 2 Hours Post Dose
Population: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations | 921.45 ng/mL | Standard Deviation 549.103 |
| PLN-74809 (Part C) - 80 mg | Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations | 1731.70 ng/mL | Standard Deviation 875.776 |
| PLN-74809 (Part C) - 160 mg | Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations | 2733.71 ng/mL | Standard Deviation 1038.402 |
| PLN-74809 (Part D) - 320 mg | Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations | 3742.78 ng/mL | Standard Deviation 1383.345 |
Secondary
Part D - Assessment of PLN-74809 Total Plasma Concentrations
Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
Time frame: Week 24, 2 Hours Post Dose
Population: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Assessment of PLN-74809 Total Plasma Concentrations | 4120.63 ng/mL | Standard Deviation 1866.606 |
Other Pre-specified
Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
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.
Time frame: Up to 12 weeks
Population: Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 1.2 Point | Standard Deviation 20.92 |
| PLN-74809 (Part C) - 80 mg | Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 0.7 Point | Standard Deviation 13.85 |
| PLN-74809 (Part C) - 160 mg | Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 3.8 Point | Standard Deviation 26.46 |
| PLN-74809 (Part D) - 320 mg | Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | -2.9 Point | Standard Deviation 31.19 |
| Placebo (Part B, C, D) | Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | -0.3 Point | Standard Deviation 16.43 |
Other Pre-specified
Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12.
Time frame: Up to 12 weeks
Population: Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | -46.1 mL | Standard Error 39.64 |
| PLN-74809 (Part C) - 80 mg | Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | 25.6 mL | Standard Error 38.57 |
| PLN-74809 (Part C) - 160 mg | Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | -25.6 mL | Standard Error 40.49 |
| PLN-74809 (Part D) - 320 mg | Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | 29.4 mL | Standard Error 43.35 |
| Placebo (Part B, C, D) | Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | -110.5 mL | Standard Error 36.38 |
Other Pre-specified
Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Time frame: Up to 12 weeks
Population: Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | 3.15 Percentage | Standard Deviation 4.796 |
| PLN-74809 (Part C) - 80 mg | Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | 0.70 Percentage | Standard Deviation 4.194 |
| PLN-74809 (Part C) - 160 mg | Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | 0.00 Percentage | Standard Deviation 3.96 |
| PLN-74809 (Part D) - 320 mg | Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | 0.20 Percentage | Standard Deviation 2.817 |
| Placebo (Part B, C, D) | Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 | 1.46 Percentage | Standard Deviation 4.951 |
Other Pre-specified
Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
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.
Time frame: Up to 24 weeks
Population: Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | -1.9 Point | Standard Deviation 17.7 |
| PLN-74809 (Part C) - 80 mg | Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough | 16.8 Point | Standard Deviation 33.78 |
Other Pre-specified
Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24.
Time frame: Up to 24 weeks
Population: Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | -35.9 mL | Standard Error 50.57 |
| PLN-74809 (Part C) - 80 mg | Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) | -109.3 mL | Standard Error 74.93 |
Other Pre-specified
Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Time frame: Up to 24 weeks
Population: Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLN-74809 (Part A) - 40 mg | Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24 | 1.31 Percentage | Standard Deviation 2.65 |
| PLN-74809 (Part C) - 80 mg | Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24 | 3.72 Percentage | Standard Deviation 4.381 |