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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.
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; approximately 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLN-74809 | Experimental | 160 mg PLN-74809 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLN-74809 | Drug | 160 mg PLN-74809 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety and Tolerability | Safety and tolerability of PLN-74809 as measured by the incidence of adverse events. | From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory 1 | Change from baseline in Forced vital capacity at 12 weeks. | 12 weeks |
| Exploratory 2 | Change from baseline in Cough Severity Visual Analog Scale at 12 weeks. Cough severity is assessed on a 100-mm linear scale ranging from "no cough" (0mm) to "worst cough" (100mm). Higher score means worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sydney Montesi, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40153543 | Derived | Montesi SB, Cosgrove GP, Turner SM, Zhou IY, Efthimiou N, Susnjar A, Catana C, Fromson C, Clark A, Decaris M, Barnes CN, Lefebvre EA, Caravan P. Dual alphavbeta6 and alphavbeta1 Inhibition over 12 Weeks Reduces Active Type I Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1229-1240. doi: 10.1164/rccm.202410-1934OC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PLN-74809 | PLN-74809: 160 mg PLN-74809 |
| FG001 | Placebo | Placebo: Matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PLN-74809 | 160 mg PLN-74809 PLN-74809: 160 mg PLN-74809 |
| BG001 | Placebo | Placebo Placebo: Matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Primary Outcome | Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung. | Posted | Mean | Standard Deviation | Unitless | 12 weeks |
|
Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days
Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
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| 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 | PLN-74809: 160 mg PLN-74809 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pliant Therapeutics Medical Monitor | Pliant Therapeutics | 650-481-6770 | clintrials@pliantrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2021 | Sep 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Sep 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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2:1 randomization PLN-74809:placebo
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double-blind
| Drug |
Matching placebo |
|
| 12 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo: Matching placebo |
|
|
| Secondary | Secondary Safety and Tolerability | Safety and tolerability of PLN-74809 as measured by the incidence of adverse events. | Posted | Count of Participants | Participants | From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose |
|
|
|
| Other Pre-specified | Exploratory 1 | Change from baseline in Forced vital capacity at 12 weeks. | Posted | Mean | Standard Deviation | mL | 12 weeks |
|
|
|
| Other Pre-specified | Exploratory 2 | Change from baseline in Cough Severity Visual Analog Scale at 12 weeks. Cough severity is assessed on a 100-mm linear scale ranging from "no cough" (0mm) to "worst cough" (100mm). Higher score means worse outcome. | Posted | Mean | Standard Deviation | Mm | 12 weeks |
|
|
|
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Placebo | Placebo: Matching placebo | 0 | 3 | 0 | 3 | 1 | 3 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Amylase increased | Investigations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Lipase increased | Investigations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 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.