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| ID | Type | Description | Link |
|---|---|---|---|
| INTEGRIS-IPF | Other Identifier | Pliant Therapeutics |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Placebo |
|
| PLN-74809 Dose Level 1 (Part A) | Experimental | PLN-74809 Dose Level 1 (Part A) - 4 weeks |
|
| PLN-74809 Dose Level 2 (Part A) | Experimental | PLN-74809 Dose Level 2 (Part A) - 4 weeks |
|
| PLN-74809 Dose Level 2 (Part B) | Experimental | PLN-74809 Dose Level 2 (Part B) - 12 weeks |
|
| PLN-74809 - Dose Level 3 (Part C) | Experimental | PLN-74809 Dose Level 3 (Part C) - 12 weeks |
|
| PLN-74809 - Dose Level 4 (Part C) | Experimental | PLN-74809 Dose Level 4 (Part C) - 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLN-74809 | Drug | PLN-74809 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks |
| 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. | Up to 12 weeks |
| 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. | Up to 48 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Assessment of PLN-74809 Total Plasma Concentrations | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
| Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pliant Therapeutics Medical Monitor | Pliant Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85032 | United States | ||
| Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843105 | Derived | Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PLN-74809 (Part A) - 40 mg | PLN-74809 (Part A): Consists of an up to 28-day screening period, a 4-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period. PLN-74809 tablet administered orally. Participants took either PLN-74809 40mg or a matching placebo with 100ml water after fasting. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2021 | May 10, 2024 |
Not provided
Not provided
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| PLN-74809 - Dose Level 5 (Part D) | Experimental | PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks |
|
| Placebo | Drug | Placebo |
|
| Up to 4 weeks |
| 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. | Up to 12 weeks |
| 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. | Up to 48 weeks |
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 | Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose | Week 24, 2 Hours Post Dose |
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 | 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 | 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 | 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 | 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 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Yale University Scool of Medicine/ Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield | Chesterfield | Missouri | 63017-3625 | United States |
| PulmonIx | Greensboro | North Carolina | 27403 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt Lung Institute at One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| Dr. Anil Dhar Medicine Professional Corporation | Windsor | Ontario | N8X 5A6 | Canada |
| CISSS de la Montérégie Centre | Greenfield Park | Quebec | J4V 2H1 | Canada |
| San Giuseppe Hospital, Multimedica S.p.a. | Milan | 20123 | Italy |
| Catharina Ziekenhuis | Eindhoven | EJ | 5623 | Netherlands |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | SZ | 6532 | Netherlands |
| New Zealand Respiratory and Sleep Institute | Greenlane | Auckland | 1051 | New Zealand |
| University of Otago Christchurch | Christchurch | 8011 | New Zealand |
| PLN-74809 (Part B) - 40 mg |
PLN-74809 (Part B): 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. PLN-74809 tablet administered orally. Participants took either PLN-74809 40mg or a matching placebo with 240ml water after fasting. |
| FG002 | PLN-74809 (Part C) - 80 mg | PLN-74809 (Part C): 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. PLN-74809 tablet administered orally. Participants took either PLN-74809 80mg or a matching placebo with 240ml water after fasting. |
| FG003 | PLN-74809 (Part C) - 160 mg | PLN-74809 (Part C): 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. PLN-74809 tablets administered orally. Participants took either PLN-74809 160mg or a matching placebo with 240ml water after fasting. |
| FG004 | PLN-74809 (Part D) -320 mg | PLN-74809 (Part D): Consists of an up to 28-day screening period, at least 24-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period. PLN-74809 tablets administered orally. Participants took either PLN-74809 320 mg or a matching placebo with 240ml water after fasting. |
| FG005 | Placebo | Matching placebo tablets administered orally. Participants took a matching placebo with water after fasting. |
| Received Placebo |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety Population included all participants who took at least 1 dose of study drug.
Overall Number of Participants is 120 not 121. One participant received both placebo and PLN-74809 320 mg due to incorrect study drug dispensation and is counted in the denominator of both treatment groups for demographic and safety reporting.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PLN-74809 (Part A) - 40 mg | PLN-74809 (Part A) - 40 mg PLN-74809 |
| BG001 | PLN-74809 (Part B) - 40 mg | PLN-74809 (Part B) - 40 mg PLN-74809 |
| BG002 | PLN-74809 (Part C) - 80 mg | PLN-74809 (Part C) - 80 mg PLN-74809 |
| BG003 | PLN-74809 (Part C) - 160 mg | PLN-74809 (Part C) - 160 mg PLN-74809 |
| BG004 | PLN-74809 (Part D) - 320 mg | PLN-74809 (Part D) - 320 mg PLN-74809 |
| BG005 | Placebo | Placebo (Part B, C, D) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 4 weeks |
|
|
| ||||||||||||||||||||||||||
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 12 weeks |
| ||||||||||||||||||||||||||||
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 48 weeks |
|
| |||||||||||||||||||||||||||
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 4 weeks |
|
| |||||||||||||||||||||||||||
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 12 weeks |
| ||||||||||||||||||||||||||||
| 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. | Safety Population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 48 weeks |
|
| |||||||||||||||||||||||||||
| 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 | Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration. | Posted | Mean | Standard Deviation | ng/mL | Week 4, 1 Hour Post Dose |
|
| ||||||||||||||||||||||||||
| 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 | Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration. | Posted | Mean | Standard Deviation | ng/mL | Week 12, 2 Hours Post Dose |
| |||||||||||||||||||||||||||
| 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 | Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration. | Posted | Mean | Standard Deviation | ng/mL | Week 24, 2 Hours Post Dose |
|
| ||||||||||||||||||||||||||
| 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. | Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria. | Posted | Least Squares Mean | Standard Error | mL | Up to 12 weeks |
| |||||||||||||||||||||||||||
| 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. | Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria. | Posted | Least Squares Mean | Standard Error | mL | Up to 24 weeks |
|
| ||||||||||||||||||||||||||
| 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. | Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter. | Posted | Mean | Standard Deviation | Percentage | Up to 12 weeks |
| |||||||||||||||||||||||||||
| 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. | Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter. | Posted | Mean | Standard Deviation | Percentage | Up to 24 weeks |
|
| ||||||||||||||||||||||||||
| 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. | Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores. | Posted | Mean | Standard Deviation | Point | Up to 12 weeks |
| |||||||||||||||||||||||||||
| 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. | Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores. | Posted | Mean | Standard Deviation | Point | Up to 24 weeks |
|
|
All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study.
Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLN-74809 (Part A) - 40 mg | PLN-74809 (Part A) - 40 mg PLN-74809 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | PLN-74809 (Part B) - 40 mg | PLN-74809 (Part B) - 40 mg PLN-74809 | 0 | 22 | 1 | 22 | 8 | 22 |
| EG002 | PLN-74809 (Part C) - 80 mg | PLN-74809 (Part C) - 80 mg PLN-74809 | 0 | 23 | 0 | 23 | 8 | 23 |
| EG003 | PLN-74809 (Part C) -160 mg | PLN-74809 (Part C) -160 mg PLN-74809 | 0 | 22 | 2 | 22 | 10 | 22 |
| EG004 | PLN-74809 (Part D) - 320 mg | PLN-74809 (Part D) - 320 mg PLN-74809 | 1 | 22 | 2 | 22 | 18 | 22 |
| EG005 | Placebo | Placebo Placebo | 0 | 31 | 3 | 31 | 14 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Bladder dilatation | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Idiopathic pulmonary fibrosis/Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute left ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Haemorrhagic arteriovenous malformation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Gastric ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Hyperlactacidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Idiopathic pulmonary fibrosis/Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Amylase increased | Investigations | Systematic Assessment |
|
Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory P. Cosgrove, MD, Vice President, Clinical Development | Pliant Therapeutics, Inc. | 1-650-481-6770 | GCosgrove@pliantrx.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2023 | Feb 13, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PLN-74809 (Part D) - 320 mg |
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks 320 mg PLN-74809 |
| OG004 | Placebo (Part B, C, D) | Placebo (Part B, C) - up to 12 weeks Placebo (Part D) - at least 24 weeks and up to 48 weeks |
|
|
|
|
| OG004 | Placebo (Part B, C, D) | Placebo (Part B, C) - up to 12 weeks Placebo (Part D) - at least 24 weeks and up to 48 weeks |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Placebo (Part B, C) - up to 12 weeks Placebo (Part D) - at least 24 weeks and up to 48 weeks |
|
|
|
| Placebo (Part B, C, D) |
Placebo (Part B, C) - up to 12 weeks Placebo (Part D) - at least 24 weeks and up to 48 weeks |
|
|
|
| OG004 | Placebo (Part B, C, D) | Placebo (Part B, C) - up to 12 weeks Placebo (Part D) - at least 24 weeks and up to 48 weeks |
|
|
|