A Phase 2 interventional study of GSK3915393 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by GlaxoSmithKline. Terminated at 56 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 158 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prior/Concomitant Therapy-
Participants received GSK3915393 80 milligrams (mg), orally, twice daily for 26 weeks.
Drug: GSK3915393
Participants received matching placebo, orally, twice daily for 26 weeks.
Drug: Placebo
GSK3915393 was administered.
Placebo was administered.
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline (CFB) in FVC at Week 26 was calculated for each participant using the FVC Week 26 result minus the Baseline FVC result. Posterior median CFB and the 95% highest posterior density (HPD) interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Time frame: Baseline (Day 1) and Week 26
Absolute Change From Baseline in Forced Vital Capacity at Weeks 4, 8, 12 and 18
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Posterior median CFB and the 95% HPD interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12 and 18
Absolute Change From Baseline in FVC (Percentage [%] Predicted) at Weeks 4, 8, 12, 18 and 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. The FVC (percentage \[%\] predicted) result at each timepoint for each participant is calculated using the formula: FVC (% predicted) equals to FVC (mL) divided by Predicted FVC (mL) multiply by 100. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline in FVC (% predicted) at each time point for each participant was calculated by subtracting the Baseline FVC (% predicted) from the FVC (% predicted) at that timepoint.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26
Proportion of Participants Who Achieved Relative Decline of Less Than or Equal to (<=) 5% in FVC From Baseline at Week 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Relative decline from Baseline in FVC (mL) at the Week 26 visit was calculated using the following formula: relative decline at Week 26 equals to (1 minus Week 26 FVC \[mL\] divided by Baseline FVC \[mL\]) multiplied by 100. Participants with relative decline of \<=5% at Week 26 were classified as responders; those with greater than (\>) 5% decline were non-responders. Participants who died due to disease progression prior to Week 26 were imputed as non-responders. Posterior median and the 95% HPD interval were derived using a Bayesian logistic regression model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Time frame: Baseline (Day 1) and Week 26
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or any other situation according to medical or scientific judgment.
Time frame: Up to Week 29
Number of Participants With Vital Signs Results by Potential Clinical Importance (PCI) Criteria
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate were measured for at least 5 minutes of rest for the participant in a quiet setting. PCI ranges were SBP (low: less than \[\<\]85 millimeter of mercury \[mmHg\], high: \>180 mmHg), DBP (low: \<45 mmHg, high: \>110 mmHg) and pulse rate (low: \<40 beat per minute \[bpm\], high: \>110 bpm). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to Week 29
Number of Participants With Electrocardiogram (ECG) Results by PCI Criteria
Triplicate 12-lead ECGs were obtained after participant has rested in supine position for 5 minutes, using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTc intervals. ECG parameters with PCI ranges were: PR Interval (low: \<110 milliseconds\[msec\], high: \>220 msec), QRS Duration (low: \<75 msec, high: \>120 msec) and QTcF Interval (\<=450 msec, \>450 msec to \<=480 msec, \>480 msec to \<=500 msec and \>500 msec). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to Week 29
Number of Participants With Hematology Laboratory Results by PCI Criteria
Hematology parameters with PCI ranges were: hematocrit (low: \<0.1 percentage of red blood cells in blood, high: \>0.54 percentage of red blood cells in blood), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>800\*10\^9/L), and white blood cell (WBC) (low: \<2\*10\^9/L and high: \>25\*10\^9/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to week 29
Number of Participants With Hepatobiliary Laboratory Results by PCI Criteria
Hepatobiliary parameters with PCI ranges were: Alanine transaminase (ALT) (high: greater than or equal to \[\>=\] 3\*upper limit of normal \[ULN\]), Aspartate aminotransferase (AST) (high: \>=3\*ULN), Alkaline phosphatase (ALP) (high: \>=2\*ULN) and total bilirubin (high: \>=2\*ULN). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to week 29
Number of Participants With Clinical Chemistry Laboratory Results by PCI Criteria
Clinical chemistry parameters with PCI ranges were: glucose (low: \<2 millimoles per liter\[mmol/L\], high: \>25 mmol/L), albumin (low: \<30 grams per liter\[g/L\]), creatine phosphokinase (CPK) (high: \>1500 international units per liter \[IU/L\]), potassium (low: \<3 mmol/L, high: \>6.0 mmol/L), sodium (low: \<130 mmol/L, high: \>155 mmol/L), blood urea nitrogen (BUN) (high: \>14 mmol/L) and calcium corrected for albumin (low: \<1.9 mmol/L, high: \>3 mmol/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to Week 29
Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Blood samples were collected at the indicated nominal time points for pharmacokinetic (PK) analysis of GSK3915393.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 4 Hours (AUC [0-4]) of GSK3915393
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Infinity (AUC [0-inf]) of GSK3915393
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
This was a placebo-controlled study to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF). This study was terminated after meeting the pre-defined futility criteria for efficacy.
| Milestone | GSK3915393 | Placebo |
|---|---|---|
| Started | 106 | 52 |
| Pharmacokinetic (pk) analysis set | 20 | 0 |
| Completed | 50 | 23 |
| Not completed | 56 | 29 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Study terminated by sponsor | 45 | 23 |
| Withdrew: Other | 0 | 1 |
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline (CFB) in FVC at Week 26 was calculated for each participant using the FVC Week 26 result minus the Baseline FVC result. Posterior median CFB and the 95% highest posterior density (HPD) interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
| Milliliters (mL) | GSK3915393 | Placebo |
|---|---|---|
| Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | -110.3 (-156.0 to -62.9) | -79.0 (-125.5 to -10.2) |
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Posterior median CFB and the 95% HPD interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
| Milliliters (mL) | GSK3915393 | Placebo |
|---|---|---|
| Week 4 | 14.2 (-17.6 to 47.2) | -71.3 (-118.8 to -26.2) |
| Week 8 | 5.6 (-23.6 to 36.6) | -70.6 (-110.7 to -28.8) |
| Week 12 | -28.9 (-60.0 to 4.6) | -67.2 (-111.3 to -24.5) |
| Week 18 | -53.4 (-97.5 to -10.1) | -78.3 (-134.4 to -17.0) |
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. The FVC (percentage \[%\] predicted) result at each timepoint for each participant is calculated using the formula: FVC (% predicted) equals to FVC (mL) divided by Predicted FVC (mL) multiply by 100. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline in FVC (% predicted) at each time point for each participant was calculated by subtracting the Baseline FVC (% predicted) from the FVC (% predicted) at that timepoint.
| Percentage of Predicted FVC | GSK3915393 | Placebo |
|---|---|---|
| Week 4 | 0.15 (-11.9 to 13.0) | -0.70 (-18.0 to 21.3) |
| Week 8 | -0.15 (-5.5 to 14.3) | -1.10 (-10.0 to 21.5) |
| Week 12 | -0.70 (-11.1 to 11.2) | -0.45 (-10.5 to 25.7) |
| Week 18 | -1.90 (-21.2 to 22.6) | 0.25 (-13.2 to 10.0) |
| Week 26 | -3.20 (-26.0 to 11.5) | -0.25 (-8.0 to 18.4) |
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Relative decline from Baseline in FVC (mL) at the Week 26 visit was calculated using the following formula: relative decline at Week 26 equals to (1 minus Week 26 FVC \[mL\] divided by Baseline FVC \[mL\]) multiplied by 100. Participants with relative decline of \<=5% at Week 26 were classified as responders; those with greater than (\>) 5% decline were non-responders. Participants who died due to disease progression prior to Week 26 were imputed as non-responders. Posterior median and the 95% HPD interval were derived using a Bayesian logistic regression model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
| Proportion of participants | GSK3915393 | Placebo |
|---|---|---|
| Proportion of Participants Who Achieved Relative Decline of Less Than or Equal to (<=) 5% in FVC From Baseline at Week 26 | 0.60 (0.46 to 0.73) | 0.79 (0.62 to 0.93) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or any other situation according to medical or scientific judgment.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| Any AEs | 64 | 35 |
| Any SAEs | 13 | 1 |
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate were measured for at least 5 minutes of rest for the participant in a quiet setting. PCI ranges were SBP (low: less than \[\<\]85 millimeter of mercury \[mmHg\], high: \>180 mmHg), DBP (low: \<45 mmHg, high: \>110 mmHg) and pulse rate (low: \<40 beat per minute \[bpm\], high: \>110 bpm). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| SBP, To Low | 1 | 0 |
| SBP, To Within Range or No Change | 101 | 51 |
| SBP, To High | 2 | 1 |
| DBP, To Low | 1 | 0 |
| DBP, To Within Range or No Change | 102 | 52 |
| DBP, To High | 1 | 0 |
| Pulse rate, To Low | 0 | 0 |
| Pulse rate, To Within Range or No Change | 102 | 51 |
| Pulse rate, To High | 2 | 1 |
Triplicate 12-lead ECGs were obtained after participant has rested in supine position for 5 minutes, using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTc intervals. ECG parameters with PCI ranges were: PR Interval (low: \<110 milliseconds\[msec\], high: \>220 msec), QRS Duration (low: \<75 msec, high: \>120 msec) and QTcF Interval (\<=450 msec, \>450 msec to \<=480 msec, \>480 msec to \<=500 msec and \>500 msec). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| PR Interval, To Low | 2 | 2 |
| PR Interval, To Within Range or No Change | 96 | 47 |
| PR Interval, To High | 2 | 4 |
| QRS Duration, To Low | 6 | 1 |
| QRS Duration, To Within Range or No Change | 93 | 48 |
| QRS Duration, To High | 6 | 3 |
| QTcF Interval, No Change or <=450msec | 91 | 44 |
| QTcF Interval, To >450 msec to <=480 msec | 6 | 4 |
| QTcF Interval, To >480 msec to <=500 msec | 3 | 0 |
| QTcF Interval, To >500 msec | 0 | 0 |
Hematology parameters with PCI ranges were: hematocrit (low: \<0.1 percentage of red blood cells in blood, high: \>0.54 percentage of red blood cells in blood), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>800\*10\^9/L), and white blood cell (WBC) (low: \<2\*10\^9/L and high: \>25\*10\^9/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| Hematocrit, To Low | 0 | 0 |
| Hematocrit, To Within Range or No Change | 100 | 52 |
| Hematocrit, To High | 4 | 0 |
| Lymphocytes, To Low | 7 | 2 |
| Lymphocytes, To Within Range or No Change | 97 | 49 |
| Lymphocytes, To High | 0 | 0 |
| Neutrophils, To Low | 0 | 0 |
| Neutrophils, To Within Range or No Change | 104 | 51 |
| Neutrophils, To High | 0 | 0 |
| Platelets, To Low | 1 | 0 |
| Platelets, To Within Range or No Change | 102 | 52 |
| Platelets, To High | 0 | 0 |
| WBC, To Low | 0 | 0 |
| WBC, To Within Range or No Change | 104 | 52 |
| WBC, To High | 0 | 0 |
Hepatobiliary parameters with PCI ranges were: Alanine transaminase (ALT) (high: greater than or equal to \[\>=\] 3\*upper limit of normal \[ULN\]), Aspartate aminotransferase (AST) (high: \>=3\*ULN), Alkaline phosphatase (ALP) (high: \>=2\*ULN) and total bilirubin (high: \>=2\*ULN). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| ALT, To Low | 0 | 0 |
| ALT, To Within Range or No Change | 103 | 52 |
| ALT, To High | 1 | 0 |
| AST, To Low | 0 | 0 |
| AST, To Within Range or No Change | 103 | 52 |
| AST, To High | 1 | 0 |
| ALP, To Low | 0 | 0 |
| ALP, To Within Range or No Change | 103 | 51 |
| ALP, To High | 1 | 0 |
| Total bilirubin, To Low | 0 | 0 |
| Total bilirubin, To Within Range or No Change | 104 | 52 |
| Total bilirubin, To High | 0 | 0 |
Clinical chemistry parameters with PCI ranges were: glucose (low: \<2 millimoles per liter\[mmol/L\], high: \>25 mmol/L), albumin (low: \<30 grams per liter\[g/L\]), creatine phosphokinase (CPK) (high: \>1500 international units per liter \[IU/L\]), potassium (low: \<3 mmol/L, high: \>6.0 mmol/L), sodium (low: \<130 mmol/L, high: \>155 mmol/L), blood urea nitrogen (BUN) (high: \>14 mmol/L) and calcium corrected for albumin (low: \<1.9 mmol/L, high: \>3 mmol/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | GSK3915393 | Placebo |
|---|---|---|
| Glucose, To Low | 0 | 0 |
| Glucose, To Within Range or No Change | 104 | 52 |
| Glucose, To High | 0 | 0 |
| Albumin, To Low | 0 | 0 |
| Albumin, To Within Range or No Change | 104 | 52 |
| Albumin, To High | 0 | 0 |
| CPK, To Low | 0 | 0 |
| CPK, To Within Range or No Change | 104 | 52 |
| CPK, To High | 0 | 0 |
| Potassium, To Low | 0 | 0 |
| Potassium, To Within Range or No Change | 104 | 50 |
| Potassium, To High | 0 | 2 |
| Sodium, To Low | 0 | 1 |
| Sodium, To Within Range or No Change | 104 | 51 |
| Sodium, To High | 0 | 0 |
| BUN, To Low | 0 | 0 |
| BUN, To Within Range or No Change | 104 | 52 |
| BUN, To High | 0 | 0 |
| Calcium corrected for albumin, To Low | 2 | 0 |
| Calcium corrected for albumin, To Within Range or No Change | 102 | 52 |
| Calcium corrected for albumin, To High | 0 | 0 |
Blood samples were collected at the indicated nominal time points for pharmacokinetic (PK) analysis of GSK3915393.
| Nanograms per milliliters (ng/mL) | GSK3915393 |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GSK3915393 | 683.87 ± 157.80 |
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
| Hours*nanogram per milliliter (h*ng/mL) | GSK3915393 |
|---|---|
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 4 Hours (AUC [0-4]) of GSK3915393 | 1337.15 ± 64.70 |
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
| Hours*nanogram per milliliter (h*ng/mL) | GSK3915393 |
|---|---|
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Infinity (AUC [0-inf]) of GSK3915393 | NA ± NA |
Collected over All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to week 29. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK3915393 | 1/106 (0.9%) | 13/106 (12.3%) | 15/106 (14.2%) |
| Placebo | 0/52 (0%) | 1/52 (1.9%) | 17/52 (32.7%) |
| Event | GSK3915393 | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 3/106 | 0/52 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/106 | 1/52 |
| Acute exacerbation idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 2/106 | 0/52 |
| Atrial fibrillationCardiac disorders | 1/106 | 0/52 |
| Coronary artery diseaseCardiac disorders | 1/106 | 0/52 |
| Inguinal herniaGastrointestinal disorders | 1/106 | 0/52 |
| Pancreatitis acuteGastrointestinal disorders | 1/106 | 0/52 |
| Rectal haemorrhageGastrointestinal disorders | 1/106 | 0/52 |
| Fractured sacrumInjury, poisoning and procedural complications | 1/106 | 0/52 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/106 | 0/52 |
| Event | GSK3915393 | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 12/106 | 7/52 |
| FatigueGeneral disorders | 1/106 | 4/52 |
| VomitingGastrointestinal disorders | 2/106 | 3/52 |
| NasopharyngitisInfections and infestations | 2/106 | 3/52 |
| Weight decreasedInvestigations | 1/106 | 3/52 |
| Age, Continuous(YEARS) | GSK3915393 | Placebo | Total |
|---|---|---|---|
| Mean | 72.1 ± 6.53 | 72.4 ± 6.33 | 72.2 ± 6.45 |
| Sex: Female, Male(Participants) | GSK3915393 | Placebo | Total |
|---|---|---|---|
| Female | 22 | 9 | 31 |
| Male | 84 | 43 | 127 |
| Race/Ethnicity, Customized(Participants) | GSK3915393 | Placebo | Total |
|---|---|---|---|
| White | 104 | 51 | 155 |
| Other | 2 | 1 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Sap, Icf, Csr
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Idiopathic Pulmonary Fibrosis→
GlaxoSmithKline