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A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

150 patients around the world
Available in Argentina
GlaxoSmithKline
150Patients around the world

This study is for people with

Pulmonary fibrosis
Idiopathic pulmonary fibrosis

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Participants with IPF diagnosed within 5 years prior to screening based on the applicable American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guideline at the time of diagnosis.
Centrally read chest High Resolution Computed Tomography (HRCT) obtained at screening or historical HRCT obtained within 12 months of screening that is consistent with Usual interstitial pneumonia (UIP) or probable UIP.
FVC greater than or equal to (>=) 45 percent (%) of predicted normal.
Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) >=25% of predicted normal corrected for hemoglobin (Hb).
Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC ≥ 0.7.
If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
If not currently receiving pirfenidone or nintedanib, participant must have stopped pirfenidone or nintedanib for at least 4 weeks prior to screening.
Body weight ≥40 kilogram (kg) and body mass index within the range 18.5-35 kilogram per meter square (kg/m2) (inclusive).
A female participant is eligible to participate if a woman of nonchildbearing potential (WONCBP).
Capable of giving signed informed consent.
Participants with Interstitial Lung Disease (ILD) associated with other known causes.
Diagnosis of sarcoidosis or any systemic autoimmune disease including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus and rheumatoid arthritis.
Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
Clinically significant non-parenchymal lung disease at screening.
Diagnosis of severe pulmonary hypertension.
Extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
History of previous lung transplant or recent major surgery within 12 weeks prior to screening or planned during the trial period.
Clinically significant respiratory tract infection requiring treatment within 4 weeks prior to and/or during the screening period.
Cigarette smoking either current or within 3 months before screening.
Current or chronic liver disease or known hepatic or biliary abnormalities with the exception of Gilbert's syndrome or asymptomatic gallstones.
Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) >2x Upper Limit of Normal (ULN) and bilirubin >1.5x ULN.
Clinically significant abnormalities detected on ECG of either rhythm or conduction, a Corrected QT interval (QTc) >450 millisecond (msec) or QTc > 480msec for participants with a bundle branch block and/or a pacemaker.
Participants with pacemakers who are not pacing at the time of the screening ECG should have a non-paced QTc <450 msec.
Prior/Concomitant Therapy
Simultaneous use of pirfenidone and nintedanib at screening.
Received systemic corticosteroids equivalent to prednisone >10 mg/day or equivalent within 2 weeks of screening period.
Use of any immunomodulatory therapies within 4 weeks prior to screening and during the screening period or planned during the study.
Immunomodulatory therapies, including but not limited to azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide, imatinib, Tumour Necrosis Factor -Alpha (TNF- α) inhibitors.
Medications that are under investigation for the treatment of IPF including inhaled treprostinil and Phosphodiesterase-4 (PDE-4) inhibitors.
Current use of systemic strong and moderate inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.
Current use of systemic CYP3A4 substrates that have a narrow therapeutic index that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.
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