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New hope for lung scarring? trial of GSK3915393 cut short

NCT ID NCT06317285

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study tested a new medicine, GSK3915393, in 158 people with idiopathic pulmonary fibrosis (IPF), a chronic lung disease that causes scarring and breathing difficulty. The goal was to see if the drug could slow lung function decline compared to a placebo. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

158 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or participant choice. * 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/m\^2) (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. 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) greater than (\>) 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 milligrams/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) 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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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • GSK Investigational Site

    Newport Beach, California, 92663, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32224, United States

  • GSK Investigational Site

    St. Petersburg, Florida, 33704, United States

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5360, United States

  • GSK Investigational Site

    Rochester, Minnesota, 55905, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Wilmington, North Carolina, 28401, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37204, United States

  • GSK Investigational Site

    Cypress, Texas, 77429, United States

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1207AAP, Argentina

  • GSK Investigational Site

    Florida, B1602DQD, Argentina

  • GSK Investigational Site

    La Plata, 1900, Argentina

  • GSK Investigational Site

    Mendoza, M5500CCG, Argentina

  • GSK Investigational Site

    Rosario, S2000DBS, Argentina

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5, Canada

  • GSK Investigational Site

    Hamilton, Ontario, L8N 4A6, Canada

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • GSK Investigational Site

    La Tronche, 38700, France

  • GSK Investigational Site

    Paris, 75018, France

  • GSK Investigational Site

    Pessac, 33604, France

  • GSK Investigational Site

    Rennes, 35000, France

  • GSK Investigational Site

    Rouen, 76000, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Essen, 45293, Germany

  • GSK Investigational Site

    Hanover, 30173, Germany

  • GSK Investigational Site

    Heidelberg, 69126, Germany

  • GSK Investigational Site

    Wuppertal, 42283, Germany

  • GSK Investigational Site

    Catania, 95123, Italy

  • GSK Investigational Site

    Monza MB, 20900, Italy

  • GSK Investigational Site

    Naples, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Perugia, 06132, Italy

  • GSK Investigational Site

    Pisa, 56124, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Sassari, 07100, Italy

  • GSK Investigational Site

    Torrette AN, Italy

  • GSK Investigational Site

    Eindhoven, 5623 EJ, Netherlands

  • GSK Investigational Site

    Rotterdam, 3015 CE, Netherlands

  • GSK Investigational Site

    Bialystok, 15-044, Poland

  • GSK Investigational Site

    Lodz, 90-153, Poland

  • GSK Investigational Site

    Poznan, 60-569, Poland

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Barcelona, Spain

  • GSK Investigational Site

    Madrid, 28006, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Oviedo, 33011, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Santander, 39011, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Edinburgh, EH16 4SA, United Kingdom

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF, United Kingdom

  • GSK Investigational Site

    London, SW3 6HP, United Kingdom

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Other studies related to the condition(s) this trial covers.