A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT06317285
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
158 participants
INTERVENTIONAL
2024-04-04
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GSK3915393
Participants will receive GSK3915393
GSK3915393
GSK3915393 will be administered.
Placebo
Participants will receive placebo.
Placebo
Placebo will be administered.
Interventions
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GSK3915393
GSK3915393 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 (if indeterminate HRCT 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 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
Exclusion Criteria
* 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 (investigator-determined).
* Clinically significant non-parenchymal lung disease (e.g., asthma, chronic obstructive 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 reported results 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 the trial 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 treatment within 4 weeks prior to and/or during the screening period.
* Cigarette smoking (including e-cigarettes) 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 (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than (\<) 35% at screening).
* 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 who are actively ventricularly pacing during the screening ECG.
* 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 of the following 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. Symptomatic cough therapies are allowed.
* Current use of systemic strong and moderate inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) (see prohibited medication section for further information) 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Paris, , France
GSK Investigational Site
Pessac, , France
GSK Investigational Site
Rennes, , France
GSK Investigational Site
Rouen, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Essen, , Germany
GSK Investigational Site
Hanover, , Germany
GSK Investigational Site
Heidelberg, , Germany
GSK Investigational Site
Wuppertal, , Germany
GSK Investigational Site
Catania, , Italy
GSK Investigational Site
Monza MB, , Italy
GSK Investigational Site
Napoli, , Italy
GSK Investigational Site
Padua, , Italy
GSK Investigational Site
Perugia, , Italy
GSK Investigational Site
Pisa, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Sassari, , Italy
GSK Investigational Site
Torrette AN, , Italy
GSK Investigational Site
Eindhoven, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Oviedo, , Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Edinburgh, , United Kingdom
GSK Investigational Site
Leeds West Yorkshire, , United Kingdom
GSK Investigational Site
London, , United Kingdom
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
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, , Argentina
GSK Investigational Site
Florida, , Argentina
GSK Investigational Site
La Plata, , Argentina
GSK Investigational Site
Mendoza, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site
Ajax, Ontario, Canada
GSK Investigational Site
Hamilton, Ontario, Canada
GSK Investigational Site
Trois-Rivières, Quebec, Canada
GSK Investigational Site
La Tronche, , France
Countries
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Other Identifiers
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2023-509371-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
220929
Identifier Type: -
Identifier Source: org_study_id
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