RecruitingRare disease

Study of Rituximab versus Placebo to Improve Lung Function in Patients with Granulomatous Lymphocytic Interstitial Lung Disease (GLILD)

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This study focuses on Granulomatous Lymphocytic Interstitial Lung Disease (GLILD), a rare lung condition that affects breathing capacity. The purpose is to evaluate how well a medication called rituximab works in improving lung function compared to placebo in people with this disease.

The treatment involves receiving rituximab or placebo through intravenous administration (delivery directly into a vein). During the study, participants will receive multiple doses of the medication or placebo over a period of about 27 weeks. The total treatment period lasts approximately 78 weeks, during which doctors will monitor changes in breathing capacity.

The medication being tested, rituximab, is already approved for use in other conditions and will be given along with sodium chloride solution, which helps deliver the medicine into the bloodstream. Throughout the study, doctors will measure how well the lungs work using various breathing tests to determine if the treatment is helping to improve lung function in people with GLILD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your lung function will be measured using a test called DLCO (diffusion capacity of the lung) to establish baseline values.
You will complete two health questionnaires: the King's Brief Interstitial Lung Disease Questionnaire and the Short Form 36 Health Survey.
A chest scan (HRCT) will be performed to assess your lung condition.
Blood samples will be collected to measure specific markers in your blood.
Step 2
Treatment phase
You will receive either rituximab or a placebo through an intravenous infusion.
The treatment will be administered into your vein.
Neither you nor your doctor will know whether you are receiving rituximab or placebo, as this is a double-blinded study.
Step 3
Follow-up assessments
Week 13: Your lung function will be tested and blood samples collected
Week 27: Comprehensive evaluation including lung function tests, chest scan, health questionnaires, and blood samples
Week 53: Lung function testing, chest scan, and blood sample collection
Week 78: Final lung function assessment
Step 4
Safety considerations
If you are a woman who can become pregnant, you must use effective birth control during the study and for 12 months after the last treatment.
Your weight must be between 50-130 kg to participate.
Regular monitoring will ensure your safety throughout the study period.

Who can join the trial?

10 criteria

Must be between 18 and 70 years old when signing the consent form
Body weight must be between 50 and 130 kilograms
Must have a confirmed diagnosis of Common Variable Immunodeficiency (CVID) according to European Society of Immunodeficiencies criteria
Must have a confirmed diagnosis of GLILD by a team of specialists including an immunologist, chest radiologist, and lung specialist
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Must show disease progression in one of these ways:
- A decrease of more than 10% in lung function test (DLCO) within the last 12 months with worsening chest scans
- Lung function test between 70% and 80% with worsening chest scans in the last 3 years
- Lung function test between 50% and 70%
- Other possible causes of declining lung function must be ruled out through appropriate testing
- Women who can become pregnant must agree to use reliable birth control during the study and for 12 months after the last treatment
- Must be able to understand and sign the informed consent form

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years old
Previous treatment with rituximab (a type of medication that affects immune system cells) in the past 12 months
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Active or chronic infection, including:
- Hepatitis B
- Hepatitis C
- HIV infection
- Tuberculosis
- History of severe allergic reactions to biological medications
- Presence of any serious medical condition that could interfere with study participation
- Pregnancy or breastfeeding
- Current participation in other clinical trials
- Unable to perform lung function tests
- History of cancer in the past 5 years (except successfully treated skin cancer)
- Severe heart, liver, or kidney disease
- Mental conditions that could affect ability to provide informed consent
- Use of immunosuppressive medications not allowed by the study protocol

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Responsive
Roskilde University
Roskilde, Denmark
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Rituximab is a medication that targets specific cells in the immune system called B-cells. It is commonly used to treat various autoimmune conditions and certain types of blood cancers. In this trial, it is being studied for its potential effects on lung function in patients with Granulomatous Lymphocytic Interstitial Lung Disease (GLILD), a rare lung condition that affects the immune system.

What is already known about the treatment

Rituximab - A monoclonal antibody medication administered through intravenous infusion, which has been established as an important therapeutic agent in both oncology and autoimmune conditions. This drug works by targeting and eliminating B-cells that carry the CD20 protein on their surface, effectively reducing inflammation and immune system activity. In this clinical trial, it is being studied for treating Granulomatous Lymphocytic Interstitial Lung Disease (GLILD), a rare lung condition characterized by inflammation and immune system dysfunction, with the specific goal of improving lung diffusion capacity. Rituximab belongs to the pharmacological class of targeted immunotherapy agents and has shown promising results in various autoimmune disorders, making it a potential candidate for treating this specific lung condition.

Investigated diseases

Granulomatous Lymphocytic Interstitial Lung Disease (GLILD) - A rare lung condition characterized by inflammation and abnormal tissue growth in the lungs. The disease involves the formation of small clusters of immune cells called granulomas, along with an increased presence of lymphocytes (white blood cells) in the lung tissue. GLILD causes gradual scarring of lung tissue and typically occurs in patients who already have immune system disorders. The condition affects the ability of the lungs to transfer oxygen into the bloodstream and causes progressive breathing difficulties. The disease can develop slowly over time, affecting both lungs and their ability to function properly.