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Study on the Effectiveness and Safety of Rituximab for Patients with Progressive Interstitial Lung Disease with Inflammation

Verified siteRegistered drugNo placebo
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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 condition known as Interstitial Lung Disease (ILD), which involves inflammation and scarring of the lung tissue. The study aims to evaluate the effectiveness and safety of a medication called Rituximab in patients with progressive ILD that has an inflammatory component. Rituximab is a medication that targets specific cells in the immune system and is administered through direct intravenous injection. The study will compare the effects of Rituximab to a placebo, which is a substance with no active medication, to see how it impacts lung function over a period of six months.

Participants in the study will receive two infusions of either Rituximab or a placebo. The main goal is to observe changes in lung function, specifically the Forced Vital Capacity (FVC), which measures the amount of air a person can exhale after taking a deep breath. The study will also monitor other health indicators, such as physical activity levels, respiratory symptoms, and any side effects that may occur during the treatment period. The trial is designed to provide valuable information on whether Rituximab can help improve lung function and quality of life for people with this type of lung disease.

Throughout the study, participants will undergo various assessments, including questionnaires about their symptoms and quality of life, as well as tests like the six-minute walk test to measure physical endurance. Additionally, blood tests will be conducted to evaluate changes in certain biological markers related to the immune system. The study will also track any adverse events, particularly infections, to ensure the safety of the participants. The findings from this trial could potentially lead to better treatment options for individuals with progressive Interstitial Lung Disease.

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, you will be asked to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will need to confirm that you meet the eligibility criteria, such as being 18 years or older and having a specific type of lung disease with an inflammatory component.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish your baseline health status. This includes measuring your lung function, specifically your forced vital capacity (FVC), which is the amount of air you can exhale after taking a deep breath.

    Additional tests may include a high-resolution CT scan of your chest and blood tests to check for specific markers related to your condition.

  3. Step 3

    Treatment phase

    You will receive two infusions of either the study medication, rituximab, or a placebo. These are given as direct intravenous injections, meaning they are administered directly into your vein.

    The infusions are spaced apart, and the exact schedule will be provided to you by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups to assess your lung function and overall health.

    You will be asked to complete questionnaires about your symptoms and quality of life, and additional tests may be conducted to track changes in your condition.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate any changes in your lung function and overall health.

    The results will help determine the effectiveness and safety of the treatment you received.

Who can join the trial?

11 criteria

  • Patients must be 18 years or older.
  • Patients must have experienced worsening of their lung disease within the last 24 months, shown by at least one of the following:
    • A decrease in lung capacity (FVC) by 10% or more of the expected value.
    • A decrease in lung capacity (FVC) by 5% to 10% of the expected value, along with:
      • Worsening breathing symptoms, or
      • Increased lung disease seen on a detailed lung scan (high-resolution CT), or
      • A decrease in the ability to transfer oxygen in the lungs (DLCO) by 15% or more of the expected value.
      • Worsening breathing symptoms and increased lung disease seen on a detailed lung scan (high-resolution CT).
      • Patients must have signs of inflammation in the lungs, shown by:
        • A previous lung sample showing certain types of immune cells (like lymphocytes) in areas away from lung scarring, or
        • A previous test showing more than 20% of a type of immune cell (lymphocytes) in lung fluid (BALF).
        • Patients must be covered by the French social security system.
        • Patients must provide written informed consent to participate.
        • Patients must be able to follow the study requirements.

Who cannot join the trial?

3 criteria

  • Patients with a history of **interstitial lung disease** cannot participate. This is a condition where the tissue in the lungs becomes scarred and stiff.
  • Patients who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population are not eligible. This means people who might be at higher risk of harm or exploitation.
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Investigated drugs

Rituximab is a medication used in this clinical trial to help treat patients with progressive Interstitial Lung Disease (ILD) that has an inflammatory component. It works by targeting specific cells in the immune system that may be causing inflammation and damage in the lungs. The goal of using Rituximab in this study is to see if it can improve lung function over a period of six months. Patients will receive two infusions of Rituximab as part of the treatment course in the trial.

What is already known about the treatment

Rituximab – Rituximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness in treating progressive interstitial lung disease (ILD) with an inflammatory component. The main therapeutic use of Rituximab in this context is to improve lung function in patients with this type of ILD. At the molecular level, Rituximab works by targeting and depleting specific immune cells called B-cells, which are involved in inflammation. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Interstitial lung disease – Interstitial lung disease (ILD) refers to a group of disorders that cause progressive scarring of lung tissue. This scarring affects the interstitium, which is the tissue and space around the air sacs of the lungs. As the disease progresses, the lung tissue becomes thickened and stiff, leading to breathing difficulties and reduced oxygen transfer to the bloodstream. Symptoms often include a persistent dry cough and shortness of breath, especially during or after physical activity. Over time, the scarring can worsen, leading to further decline in lung function. The progression of ILD varies among individuals, with some experiencing rapid deterioration and others having a slower course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-501335-16-00Protocol codeDR210299Estimated enrolment126 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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