Phase
Condition
Cystic Fibrosis
Lung Injury
Lung Disease
Treatment
Placebo
GSK3915393
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with IPF diagnosed within 5 years prior to screening based on theapplicable American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guidelineat the time of diagnosis.
Centrally read chest High Resolution Computed Tomography (HRCT) obtained atscreening or historical HRCT obtained within 12 months of screening that isconsistent with Usual interstitial pneumonia (UIP) or probable UIP (if indeterminateHRCT finding, IPF may be confirmed locally by historical biopsy).
FVC greater than or equal to (>=) 45 percent (%) of predicted normal.
Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) >=25% of predicted normalcorrected 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 forat least 12 weeks prior to screening.
If not currently receiving pirfenidone or nintedanib, participant must have stoppedpirfenidone 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 kilogramper meter square (kg/m2) (inclusive).
A female participant is eligible to participate if a woman of nonchildbearingpotential (WONCBP)
Capable of giving signed informed consent
Exclusion
Exclusion Criteria:
Participants with Interstitial Lung Disease (ILD) associated with other knowncauses.
Diagnosis of sarcoidosis or any systemic autoimmune disease (including but notlimited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosusand rheumatoid arthritis).
Acute IPF exacerbation within 6 months prior to screening and/or during thescreening period (investigator-determined).
Clinically significant non-parenchymal lung disease (e.g., asthma, chronicobstructive pulmonary disease, cavitary or pleural diseases) at screening.
Diagnosis of severe pulmonary hypertension (investigator-determined)
Extent of emphysema is greater than the extent of fibrosis according to reportedresults from the most recent HRCT.
History of previous lung transplant or recent major surgery (investigator-determined) within 12 weeks prior to screening or planned during thetrial period. Registration on a transplant waiting list is allowed.
Clinically significant respiratory tract infection (e.g., active tuberculosis,infectious pneumonia, Corona virus disease 2019 [COVID-19]) requiring treatmentwithin 4 weeks prior to and/or during the screening period.
Cigarette smoking (including e-cigarettes) either current or within 3 months beforescreening.
Current or chronic liver disease or known hepatic or biliary abnormalities (with theexception 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 (isolated bilirubin >1.5xULNis acceptable if bilirubin is fractionated and direct bilirubin less than (<) 35% atscreening).
Clinically significant abnormalities detected on ECG of either rhythm or conduction,a Corrected QT interval (QTc) >450 millisecond (msec) or QTc > 480msec forparticipants with a bundle branch block and/or a pacemaker who are activelyventricularly pacing during the screening ECG.
Participants with pacemakers who are not pacing at the time of the screening ECGshould 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 equivalentwithin 2 weeks of screening period.
Use of any of the following therapies within 4 weeks prior to screening and duringthe screening period or planned during the study:
Immunomodulatory therapies, including but not limited to azathioprine, mycophenolatemofetil, methotrexate, tacrolimus, cyclophosphamide, imatinib, Tumour NecrosisFactor -Alpha (TNF- α) inhibitors.
Medications that are under investigation for the treatment of IPF including inhaledtreprostinil and Phosphodiesterase-4 (PDE-4) inhibitors. Symptomatic cough therapiesare allowed.
Current use of systemic strong and moderate inducers or inhibitors of CytochromeP450 3A4 (CYP3A4) (see prohibited medication section for further information) thatcannot be safely discontinued or switched to an alternative agent at least 14 daysbefore randomization.
Current use of systemic CYP3A4 substrates that have a narrow therapeutic index thatcannot be safely discontinued or switched to an alternative agent at least 14 daysbefore randomization.
Study Design
Connect with a study center
GSK Investigational Site
Buenos Aires, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires 3435910, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Ciudad AutOnoma de Buenos Aires, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Bueno, C1207AAP
ArgentinaSite Not Available
GSK Investigational Site
Florida, B1602DQD
ArgentinaSite Not Available
GSK Investigational Site
Florida 3433908, B1602DQD
ArgentinaSite Not Available
GSK Investigational Site
La Plata, 1900
ArgentinaSite Not Available
GSK Investigational Site
La Plata 3432043, 1900
ArgentinaSite Not Available
GSK Investigational Site
Mendoza, M5500CCG
ArgentinaSite Not Available
GSK Investigational Site
Mendoza 3844421, M5500CCG
ArgentinaSite Not Available
GSK Investigational Site
Rosario, S2000DBS
ArgentinaSite Not Available
GSK Investigational Site
Rosario 3838583, S2000DBS
ArgentinaSite Not Available
GSK Investigational Site
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
GSK Investigational Site
Vancouver 6173331, British Columbia 5909050 V5Z 1M9
CanadaSite Not Available
GSK Investigational Site
Saint John's, Newfoundland and Labrador A1B 3V6
CanadaSite Not Available
GSK Investigational Site
St. John's 6324733, Newfoundland and Labrador 6354959 A1B 3V6
CanadaSite Not Available
GSK Investigational Site
Ajax, Ontario L1S 2J5
CanadaSite Not Available
GSK Investigational Site
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
GSK Investigational Site
Ajax 5882873, Ontario 6093943 L1S 2J5
CanadaSite Not Available
GSK Investigational Site
Hamilton 5969782, Ontario 6093943 L8N 4A6
CanadaSite Not Available
GSK Investigational Site
Trois RiviEres, Quebec G8T 7A1
CanadaSite Not Available
GSK Investigational Site
Trois-Rivières 6169141, Quebec 6115047 G8T 7A1
CanadaSite Not Available
GSK Investigational Site
La Tronche, 38700
FranceSite Not Available
GSK Investigational Site
La Tronche 3006131, 38700
FranceSite Not Available
GSK Investigational Site
Paris, 75018
FranceSite Not Available
GSK Investigational Site
Paris 2988507, 75018
FranceSite Not Available
GSK Investigational Site
Pessac 2987805, 33604
FranceSite Not Available
GSK Investigational Site
Pessac cedex, 33604
FranceSite Not Available
GSK Investigational Site
Rennes, 35000
FranceSite Not Available
GSK Investigational Site
Rennes 2983990, 35000
FranceSite Not Available
GSK Investigational Site
Rouen 2982652, 76000
FranceSite Not Available
GSK Investigational Site
Rouen Cedex, 76000
FranceSite Not Available
GSK Investigational Site
Toulouse 2972315, 31059
FranceSite Not Available
GSK Investigational Site
Toulouse cedex 9, 31059
FranceSite Not Available
GSK Investigational Site
Essen, 45293
GermanySite Not Available
GSK Investigational Site
Essen 2928810, 45293
GermanySite Not Available
GSK Investigational Site
Hannover, 30173
GermanySite Not Available
GSK Investigational Site
Hanover 2910831, 30173
GermanySite Not Available
GSK Investigational Site
Heidelberg, 69126
GermanySite Not Available
GSK Investigational Site
Heidelberg 2907911, 69126
GermanySite Not Available
GSK Investigational Site
Immenhausen, 34376
GermanySite Not Available
GSK Investigational Site
Stuttgart, 70839
GermanySite Not Available
GSK Investigational Site
Wuppertal, 42283
GermanySite Not Available
GSK Investigational Site
Wuppertal 2805753, 42283
GermanySite Not Available
GSK Investigational Site
Catania, 95123
ItalySite Not Available
GSK Investigational Site
Catania 2525068, 95123
ItalySite Not Available
GSK Investigational Site
Monza MB, 20900
ItalySite Not Available
GSK Investigational Site
Napoli,
ItalySite Not Available
GSK Investigational Site
Napoli 9031661,
ItalySite Not Available
GSK Investigational Site
Padova, 35128
ItalySite Not Available
GSK Investigational Site
Padua 3171728, 35128
ItalySite Not Available
GSK Investigational Site
Perugia, 06132
ItalySite Not Available
GSK Investigational Site
Perugia 3171180, 06132
ItalySite Not Available
GSK Investigational Site
Pisa, 56124
ItalySite Not Available
GSK Investigational Site
Pisa 3170647, 56124
ItalySite Not Available
GSK Investigational Site
Roma, 00168
ItalySite Not Available
GSK Investigational Site
Roma 8957247, 00168
ItalySite Not Available
GSK Investigational Site
Sassari, 07100
ItalySite Not Available
GSK Investigational Site
Sassari 3167096, 07100
ItalySite Not Available
GSK Investigational Site
Torrette AN,
ItalySite Not Available
GSK Investigational Site
Eindhoven, 5623 EJ
NetherlandsSite Not Available
GSK Investigational Site
Eindhoven 2756253, 5623 EJ
NetherlandsSite Not Available
GSK Investigational Site
Rotterdam, 3015 CE
NetherlandsSite Not Available
GSK Investigational Site
Rotterdam 2747891, 3015 CE
NetherlandsSite Not Available
GSK Investigational Site
Bialystok, 15-044
PolandSite Not Available
GSK Investigational Site
Bialystok 776069, 15-044
PolandSite Not Available
GSK Investigational Site
Lodz, 90-153
PolandSite Not Available
GSK Investigational Site
Lodz 3093133, 90-153
PolandSite Not Available
GSK Investigational Site
Poznan, 60-569
PolandSite Not Available
GSK Investigational Site
Poznan 3088171, 60-569
PolandSite Not Available
GSK Investigational Site
Barcelona, 08907
SpainSite Not Available
GSK Investigational Site
Barcelona 3128760,
SpainSite Not Available
GSK Investigational Site
Madrid, 28007
SpainSite Not Available
GSK Investigational Site
Madrid 3117735, 28007
SpainSite Not Available
GSK Investigational Site
Oviedo, 33011
SpainSite Not Available
GSK Investigational Site
Oviedo 3114711, 33011
SpainSite Not Available
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
SpainSite Not Available
GSK Investigational Site
Santander, 39011
SpainSite Not Available
GSK Investigational Site
Santander 3109718, 39011
SpainSite Not Available
GSK Investigational Site
Santiago de Compostela, 15706
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Seville 2510911, 41013
SpainSite Not Available
GSK Investigational Site
Edinburgh, EH16 4SA
United KingdomSite Not Available
GSK Investigational Site
Edinburgh 2650225, EH16 4SA
United KingdomSite Not Available
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
London, SW3 6HP
United KingdomSite Not Available
GSK Investigational Site
London 2643743, SW3 6HP
United KingdomSite Not Available
GSK Investigational Site
Los Angeles, California 90033
United StatesSite Not Available
GSK Investigational Site
Newport Beach, California 92663
United StatesSite Not Available
GSK Investigational Site
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
GSK Investigational Site
Jacksonville, Florida 32224
United StatesSite Not Available
GSK Investigational Site
Kissimmee, Florida 34746
United StatesSite Not Available
GSK Investigational Site
Saint Petersburg, Florida 33704
United StatesSite Not Available
GSK Investigational Site
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
GSK Investigational Site
St. Petersburg 4171563, Florida 4155751 33704
United StatesSite Not Available
GSK Investigational Site
Ann Arbor, Michigan 48109-5360
United StatesSite Not Available
GSK Investigational Site
Ann Arbor 4984247, Michigan 5001836 48109-5360
United StatesSite Not Available
GSK Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
GSK Investigational Site
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
GSK Investigational Site
Albany, New York 12208
United StatesSite Not Available
GSK Investigational Site
New York, New York 10065
United StatesSite Not Available
GSK Investigational Site
New York 5128581, New York 5128638 10065
United StatesSite Not Available
GSK Investigational Site
Wilmington, North Carolina 28401
United StatesSite Not Available
GSK Investigational Site
Wilmington 4499379, North Carolina 4482348 28401
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
GSK Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
GSK Investigational Site
Nashville, Tennessee 37204
United StatesSite Not Available
GSK Investigational Site
Nashville 4644585, Tennessee 4662168 37204
United StatesSite Not Available
GSK Investigational Site
Cypress, Texas 77429
United StatesSite Not Available
GSK Investigational Site
Cypress 4684724, Texas 4736286 77429
United StatesSite Not Available

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