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Study on the Effects of GSK3915393 for Patients with Idiopathic Pulmonary Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The trial will evaluate a new treatment called GSK3915393, which is a film-coated tablet taken by mouth. The purpose of the study is to assess how effective and safe this medication is in reducing the decline in lung volume for people with IPF.

Participants in the study will be randomly assigned to receive either the GSK3915393 tablet or a placebo, which looks like the real medication but does not contain the active substance. The study will last for about 26 weeks, during which participants will take the medication regularly and attend scheduled visits to monitor their health and lung function. The main focus will be on measuring changes in lung capacity over time.

Throughout the study, participants will undergo various health checks, including assessments of vital signs like blood pressure and heart rate, as well as laboratory tests to ensure their safety. The trial aims to provide valuable information on whether GSK3915393 can help slow down the progression of Idiopathic Pulmonary Fibrosis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the GSK3915393 medication or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  2. Step 2

    Medication administration

    The participant will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant's lung function will be monitored. This includes measuring the Forced Vital Capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

    Assessments will occur at various intervals: Weeks 4, 8, 12, 18, and 26. These assessments will help determine any changes in lung function from the baseline measurement taken at the start of the study.

  4. Step 4

    Safety evaluations

    The participant will undergo regular safety evaluations to monitor for any adverse effects. This includes checking vital signs such as blood pressure, body temperature, and pulse rate.

    Additional evaluations will include electrocardiograms and laboratory tests to assess blood and liver function.

  5. Step 5

    Completion of the study

    The study is expected to last for 26 weeks. At the end of this period, the participant will have a final assessment to evaluate the overall impact of the treatment on lung function and any side effects experienced during the trial.

Who can join the trial?

6 criteria

  • The patient must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 5 years. This diagnosis should follow specific guidelines used by doctors.
  • The patient should have a Forced Vital Capacity (FVC) of at least 45% of what is considered normal. FVC is a measure of how much air a person can exhale after taking a deep breath.
  • The patient should have a Diffusing Capacity for Carbon Monoxide (DLCO) of at least 25% of what is considered normal. DLCO is a test that measures how well the lungs can transfer oxygen into the blood.
  • If the patient is taking medications called antifibrotics (such as nintedanib or pirfenidone), they must have been on a stable dose for at least 12 weeks before the study starts. Antifibrotics are drugs used to slow down lung damage in IPF.
  • If the patient is not taking approved antifibrotics, there should be a valid reason, such as previous failure of the medication, medical reasons that prevent its use, not meeting criteria for treatment, or personal choice.
  • Both male and female patients can participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring of the lungs for an unknown reason.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, are not included in this study.
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Investigated drugs

GSK3915393 is a medication being studied for its potential to help people with Idiopathic Pulmonary Fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to see if this medication can slow down the loss of lung volume in people with IPF, which could help them breathe more easily and improve their quality of life.

What is already known about the treatment

GSK3915393 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating Idiopathic Pulmonary Fibrosis (IPF). It is in the experimental phase, with ongoing research to determine its effectiveness and safety. The main therapeutic indication is to slow down the decline in lung volume associated with IPF. At the molecular level, it is believed to work by targeting specific pathways involved in lung tissue scarring. It falls under the pharmacological classification of investigational drugs for respiratory conditions.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe. The exact cause of IPF is unknown, which is why it is termed "idiopathic." Over time, the thickened and stiff lung tissue hampers the lungs' ability to transfer oxygen into the bloodstream. As the disease progresses, individuals may experience worsening shortness of breath and a persistent dry cough. The progression of IPF varies among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509371-16-00Protocol code220929Estimated enrolment150 patientsSponsorGlaxosmithkline Research & Development Limited

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