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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
GSK3915393 will be administered.
Placebo will be administered.
Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26
Time frame: Baseline and at Week 26
Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18
Time frame: Baseline and at Week 4, Week 8, Week 12 and Week 18
Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26
Time frame: Baseline and at Week 4, Week 8, Week 12, Week 18 and Week 26
Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26
Time frame: Baseline and at Week 26
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 26
Number of Participants with Clinically Important Findings in Vital Signs
Time frame: Baseline and Up to Week 26
Number of Participants with Clinically Important Findings in Electrocardiogram (ECG)
Time frame: Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Haematology
Time frame: Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Hepatobiliary Parameters
Time frame: Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Clinical Chemistry
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GSK Investigational Site
Newport Beach, California, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
St. Petersburg, Florida, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Cypress, Texas, United States
...and 46 more locations
Time frame: Baseline and up to Week 26
Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants
Time frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour (h) post-dose)
Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393
Time frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour (h) post-dose)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393
Time frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour (h) post-dose)