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

2 1 1

What is this study about?

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.

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.

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.

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

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 Study?

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
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 Study?

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
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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Roskilde University	Roskilde	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Hjsmf Bkjsci Hz	Bergen	Norway
Hjbdlvzw Uqofharyih Cevgpbj Hyzgxdpo	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.09.2025
Finland	Not yet recruiting	01.09.2025
Norway	Recruiting	01.09.2025
Sweden	Not yet recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Interstitial lung disease

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.

Trial ID:

2024-517667-23-00

Protocol code:

GRIT

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?