A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
- - 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 (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:
- - 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 (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.
- - 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.
- - 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.
- - 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06317285 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
GlaxoSmithKline |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
GSK Clinical Trials |
Principal Investigator Affiliation | GlaxoSmithKline |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis |
Arms
Experimental: GSK3915393
Participants will receive GSK3915393
Experimental: Placebo
Participants will receive placebo.
Interventions
Drug: - GSK3915393
GSK3915393 will be administered.
Drug: - Placebo
Placebo will be administered.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
GSK Investigational Site
Los Angeles, California, 90033
Status
Recruiting
Address
GSK Investigational Site
Newport Beach, California, 92663
Status
Recruiting
Address
GSK Investigational Site
Jacksonville, Florida, 32224
Status
Recruiting
Address
GSK Investigational Site
Saint Petersburg, Florida, 33704
Status
Recruiting
Address
GSK Investigational Site
Ann Arbor, Michigan, 48109-5360
Status
Recruiting
Address
GSK Investigational Site
Rochester, Minnesota, 55905
Status
Recruiting
Address
GSK Investigational Site
New York, New York, 10065
Status
Recruiting
Address
GSK Investigational Site
Wilmington, North Carolina, 28401
Status
Recruiting
Address
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
GSK Investigational Site
Nashville, Tennessee, 37204
Status
Recruiting
Address
GSK Investigational Site
Cypress, Texas, 77429
International Sites
Status
Recruiting
Address
GSK Investigational Site
Buenos Aires, , C1426ABP
Status
Recruiting
Address
GSK Investigational Site
Ciudad Autonoma De Bueno, , C1207AAP
Status
Recruiting
Address
GSK Investigational Site
Florida, , B1602DQD
Status
Recruiting
Address
GSK Investigational Site
La Plata, , 1900
Status
Recruiting
Address
GSK Investigational Site
Mendoza, , M5500CCG
Status
Recruiting
Address
GSK Investigational Site
Rosario, , S2000DBS
Status
Recruiting
Address
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9
Status
Completed
Address
GSK Investigational Site
Saint John's, Newfoundland and Labrador, A1B 3V6
Status
Recruiting
Address
GSK Investigational Site
Ajax, Ontario, L1S 2J5
Status
Recruiting
Address
GSK Investigational Site
Hamilton, Ontario, L8N 4A6
Status
Recruiting
Address
GSK Investigational Site
Trois RiviEres, Quebec, G8T 7A1
Status
Recruiting
Address
GSK Investigational Site
La Tronche, , 38700
Status
Recruiting
Address
GSK Investigational Site
Paris, , 75018
Status
Recruiting
Address
GSK Investigational Site
Pessac cedex, , 33604
Status
Recruiting
Address
GSK Investigational Site
Rennes, , 35000
Status
Recruiting
Address
GSK Investigational Site
Rouen Cedex, , 76000
Status
Recruiting
Address
GSK Investigational Site
Toulouse cedex 9, , 31059
Status
Recruiting
Address
GSK Investigational Site
Essen, , 45293
Status
Recruiting
Address
GSK Investigational Site
Hannover, , 30173
Status
Recruiting
Address
GSK Investigational Site
Heidelberg, , 69126
Status
Recruiting
Address
GSK Investigational Site
Immenhausen, , 34376
Status
Recruiting
Address
GSK Investigational Site
Wuppertal, , 42283
Status
Recruiting
Address
GSK Investigational Site
Catania, , 95123
Status
Recruiting
Address
GSK Investigational Site
Monza MB, , 20900
Status
Recruiting
Address
GSK Investigational Site
Napoli, ,
Status
Recruiting
Address
GSK Investigational Site
Padova, , 35128
Status
Recruiting
Address
GSK Investigational Site
Perugia, , 06132
Status
Recruiting
Address
GSK Investigational Site
Pisa, , 56124
Status
Recruiting
Address
GSK Investigational Site
Roma, , 00168
Status
Recruiting
Address
GSK Investigational Site
Sassari, , 07100
Status
Recruiting
Address
GSK Investigational Site
Torrette AN, ,
Status
Recruiting
Address
GSK Investigational Site
Eindhoven, , 5623 EJ
Status
Recruiting
Address
GSK Investigational Site
Rotterdam, , 3015 CE
Status
Recruiting
Address
GSK Investigational Site
Bialystok, , 15-044
Status
Recruiting
Address
GSK Investigational Site
Lodz, , 90-153
Status
Recruiting
Address
GSK Investigational Site
Lodz, , 90-153
Status
Recruiting
Address
GSK Investigational Site
Poznan, , 60-569
Status
Recruiting
Address
GSK Investigational Site
Barcelona, , 08907
Status
Recruiting
Address
GSK Investigational Site
Barcelona, ,
Status
Recruiting
Address
GSK Investigational Site
Madrid, , 28006
Status
Recruiting
Address
GSK Investigational Site
Madrid, , 28007
Status
Recruiting
Address
GSK Investigational Site
Oviedo, , 33011
Status
Recruiting
Address
GSK Investigational Site
Pozuelo De AlarcOn Madr, , 28223
Status
Recruiting
Address
GSK Investigational Site
Santander, , 39011
Status
Recruiting
Address
GSK Investigational Site
Santiago de Compostela, , 15706
Status
Recruiting
Address
GSK Investigational Site
Sevilla, , 41013
Status
Recruiting
Address
GSK Investigational Site
Edinburgh, , EH16 4SA
Status
Recruiting
Address
GSK Investigational Site
Leeds West Yorkshire, , LS9 7TF
Status
Recruiting
Address
GSK Investigational Site
London, , SW3 6HP