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

Last updated: April 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Cystic Fibrosis

Lung Injury

Idiopathic Pulmonary Fibrosis

Treatment

Placebo

GSK3915393

Clinical Study ID

NCT06317285
220929
2023-509371-16-00
  • Ages > 18
  • All Genders

Study Summary

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.

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

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 04, 2024
Estimated Completion Date:
March 24, 2026

Connect with a study center

  • GSK Investigational Site

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, C1426ABP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma De Bueno, C1207AAP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    La Plata, 1900
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mendoza, M5500CCG
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, S2000DBS
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Saint John's, Newfoundland and Labrador A1B 3V6
    Canada

    Completed

  • GSK Investigational Site

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Trois RiviEres, Quebec G8T 7A1
    Canada

    Active - Recruiting

  • GSK Investigational Site

    La Tronche, 38700
    France

    Active - Recruiting

  • GSK Investigational Site

    Paris, 75018
    France

    Active - Recruiting

  • GSK Investigational Site

    Pessac cedex, 33604
    France

    Active - Recruiting

  • GSK Investigational Site

    Rennes, 35000
    France

    Active - Recruiting

  • GSK Investigational Site

    Rouen Cedex, 76000
    France

    Active - Recruiting

  • GSK Investigational Site

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • GSK Investigational Site

    Essen, 45293
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Hannover, 30173
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Immenhausen, 34376
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Stuttgart, 70839
    Germany

    Site Not Available

  • GSK Investigational Site

    Wuppertal, 42283
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Catania, 95123
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Monza MB, 20900
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Napoli,
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Padova, 35128
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Perugia, 06132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Pisa, 56124
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma, 00168
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Sassari, 07100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Torrette AN,
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Eindhoven, 5623 EJ
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Rotterdam, 3015 CE
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Bialystok, 15-044
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Lodz, 90-153
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Barcelona,
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Oviedo, 33011
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De AlarcOn Madr, 28223
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Santander, 39011
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Edinburgh, EH16 4SA
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London, SW3 6HP
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • GSK Investigational Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • GSK Investigational Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • GSK Investigational Site

    Kissimmee, Florida 34746
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Petersburg, Florida 33704
    United States

    Active - Recruiting

  • GSK Investigational Site

    Ann Arbor, Michigan 48109-5360
    United States

    Active - Recruiting

  • GSK Investigational Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • GSK Investigational Site

    Albany, New York 12208
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10065
    United States

    Active - Recruiting

  • GSK Investigational Site

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • GSK Investigational Site

    Nashville, Tennessee 37204
    United States

    Active - Recruiting

  • GSK Investigational Site

    Cypress, Texas 77429
    United States

    Active - Recruiting

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