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Study on the Effects of Bexotegrast 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 a lung disease called idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred over time, making it difficult to breathe. The study will test a new treatment called Bexotegrast, also known by its code name PLN-74809. Bexotegrast is taken as a film-coated tablet and is being compared to a placebo to see how effective and safe it is for people with IPF.

The purpose of the study is to understand how Bexotegrast affects lung function in people with IPF over a period of 52 weeks. Participants will be randomly assigned to receive either Bexotegrast or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The main focus will be on changes in lung capacity, specifically measuring something called forced vital capacity (FVC), which is a way to assess how well the lungs are working.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study will also look at other aspects of the disease, such as the time it takes for the disease to progress, changes in symptoms like cough and breathlessness, and overall quality of life. The safety of Bexotegrast will be closely monitored by tracking any side effects or serious health events that occur during the study period.

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, participants will be randomly assigned to receive either the medication bexotegrast or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.

  2. Step 2

    Medication administration

    Participants will take the assigned medication in the form of a film-coated tablet orally. The dosage and frequency will be determined based on the study's dose-ranging protocol.

  3. Step 3

    Treatment duration

    The treatment will continue for a period of 52 weeks. During this time, participants will be monitored for changes in their lung function and overall health.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants will undergo regular assessments to measure the force vital capacity (FVC), which is a test to evaluate lung function. Other assessments will include monitoring for any adverse effects and changes in symptoms such as cough and breathlessness.

  5. Step 5

    End of study evaluation

    At the end of the 52-week period, participants will have a final evaluation to assess the overall impact of the treatment on their condition. This will include a review of lung function tests and any changes in symptoms or quality of life.

Who can join the trial?

5 criteria

  • Must be **40 years of age or older** before the screening process.
  • Must have been diagnosed with **idiopathic pulmonary fibrosis (IPF)** within the last **7 years**. This diagnosis should follow specific guidelines and be confirmed by a central review. An **HRCT scan** (a special type of lung scan) done within the last **2 years** can be used to check eligibility.
  • Must have a **force vital capacity (FVC)** percentage predicted of **45% or higher**. This is a measure of lung function and needs to be confirmed by a central review.
  • Must have a **diffusing capacity for carbon monoxide** percentage predicted (adjusted for hemoglobin) of **30% or more but less than 90%**. This is another measure of lung function and also needs to be confirmed by a central review.
  • If currently receiving treatment for IPF, the treatment should be at a **stable dose for at least 12 weeks** before the screening process.

Who cannot join the trial?

12 criteria

  • Having any other lung disease besides idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred for an unknown reason.
  • Having a history of lung cancer.
  • Having a recent lung infection.
  • Using certain medications that might interfere with the study.
  • Having a history of significant heart disease.
  • Having uncontrolled high blood pressure.
  • Having a history of liver disease.
  • Having a history of kidney disease.
  • Being pregnant or breastfeeding.
  • Having participated in another clinical trial recently.
  • Having a history of drug or alcohol abuse.
  • Having any condition that the study doctors think would make it unsafe to participate.
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Investigated drugs

Bexotegrast is a medication being studied for its potential to treat idiopathic pulmonary fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to see how well bexotegrast can improve lung function over a period of 52 weeks.

What is already known about the treatment

Bexotegrast – Bexotegrast is administered orally and is currently being studied in clinical trials for its potential to treat idiopathic pulmonary fibrosis (IPF). It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for bexotegrast is to improve lung function in patients with IPF by increasing their force vital capacity. At the molecular level, bexotegrast works by inhibiting specific proteins that contribute to tissue scarring in the lungs. It is classified pharmacologically as an anti-fibrotic agent.

Investigated diseases

Idiopathic Pulmonary Fibrosis (IPF) – Idiopathic pulmonary fibrosis 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 thickening and stiffening of lung tissue reduce the lungs' ability to transfer oxygen into the bloodstream. Symptoms often include a persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, individuals may experience fatigue, weight loss, and clubbing of the fingers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-506185-31-00Protocol codePLN-74809-IPF-206Estimated enrolment1 113 patientsSponsorPliant Therapeutics Inc.

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