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Study of tezepelumab in patients with progressive pulmonary fibrosis and increased eosinophil levels in blood

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What is this trial about?

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

This clinical trial focuses on progressive pulmonary fibrosis, a serious lung condition where scarring of lung tissue worsens over time, particularly in patients who show increased levels of specific white blood cells called eosinophils. The study will test a medication called Tezepelumab, which is given as an injection under the skin.

The purpose of this research is to determine if Tezepelumab can reduce the number of eosinophils in the blood compared to placebo after 24 weeks of treatment in people with progressive pulmonary fibrosis. The medication will be administered through subcutaneous injection at a dose of 210 mg.

During the study, participants will receive either Tezepelumab or placebo for 24 weeks. After this initial period, some participants may continue receiving treatment in what is called an open-label extension phase. Throughout the study, doctors will monitor various aspects of lung function and overall health through different tests and examinations to evaluate how well the treatment works.

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 treatment phase
The treatment phase begins with receiving tezepelumab or placebo through subcutaneous injection (under the skin).
This phase will continue for 24 weeks (approximately 6 months).
During this time, you will continue taking your current antifibrotic medication (nintedanib or pirfenidone) at the same dose.
Step 2
Regular monitoring
Your blood cell counts will be monitored regularly, with special attention to eosinophil levels (a type of white blood cell).
Regular tests will measure your lung function, including breathing capacity and oxygen levels.
You will complete quality of life questionnaires to assess your well-being.
A 6-minute walking test will be performed to evaluate your exercise capacity.
Step 3
Safety monitoring
Regular monitoring for any changes in your condition or possible side effects.
Your oxygen levels will be checked through capillary blood tests.
If you are taking corticosteroids, the dose must remain at or below 10mg per day.
Step 4
Extended follow-up
The total follow-up period continues until week 56 (approximately 13 months).
Final assessments will be conducted to evaluate the long-term effects of the treatment.
The study will track any hospitalizations or changes in your lung condition during this period.

Who can join the trial?

9 criteria

Must sign a written informed consent form
Must be at least 18 years old (both men and women can participate)
Must have been diagnosed with one of these conditions: - Idiopathic pulmonary fibrosis (IPF) - a lung condition causing scarring - Progressive pulmonary fibrosis with chronic eosinophilic pneumonia - Fibrotic hypersensitivity pneumonitis - lung inflammation from breathing in certain substances - Connective tissue disease related lung disease with progressive scarring
Must be taking stable doses of anti-scarring medication (nintedanib or pirfenidone) for at least 2 months
If taking immune-suppressing medications, the dose must be stable for at least 3 months (for prednisolone, must be taking 10mg or less daily for at least 4 weeks)
Must have elevated levels of eosinophils (a type of white blood cell) in either: - Blood test showing ≥150 cells per microliter, or - Lung fluid test showing ≥10% within the past 12 months
Women who can become pregnant must use effective birth control methods throughout the study until week 56
Women must have negative pregnancy tests before starting and throughout the study until week 56
Men who are sexually active with women who can become pregnant must use condoms with spermicide from day 1 until 12 weeks after the last study treatment

Who cannot join the trial?

17 criteria

Age below 18 or above 75 years old
Pregnancy or breastfeeding
Previous treatment with Tezepelumab (the study medication)
Active or untreated tuberculosis (an infectious disease affecting the lungs)
History of cancer within the past 5 years
Severe liver disease or abnormal liver function tests
Severe kidney disease or impaired kidney function
Uncontrolled high blood pressure
Recent heart problems or stroke (within last 6 months)
Active infections requiring treatment
Participation in other clinical trials within the past 30 days
Known allergic reactions to similar medications
Use of immunosuppressive medications (drugs that lower the body's immune response)
Substance abuse or alcohol dependency
Mental health conditions that could interfere with study participation
Inability to perform breathing tests required by the study
History of severe allergic reactions or anaphylaxis (a serious, life-threatening allergic reaction)

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Verified sites

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

Verified
Klinikum der Universitaet Muenchen AöR
Munich, Germany
Verified
Medizinische Hochschule Hannover
Hanover, Germany
Responsive
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, Germany

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Investigated drugs

Tezepelumab is a medication that works by targeting a protein called TSLP (thymic stromal lymphopoietin). It is designed to help patients with progressive pulmonary fibrosis, a type of lung disease that causes scarring of the lung tissue. This medication specifically aims to reduce the number of eosinophils (a type of white blood cell) in the blood. It is administered as an antibody treatment and may help slow down the progression of lung fibrosis, particularly in patients who have high levels of eosinophils in their blood.

Tezepelumab

What is already known about the treatment

Tezepelumab - A monoclonal antibody medication administered through subcutaneous injection that targets thymic stromal lymphopoietin (TSLP), a key player in inflammatory responses. This biological therapy is being investigated for treating progressive pulmonary fibrosis with eosinophilia, where it works by blocking TSLP signaling and reducing eosinophil levels in the blood. Tezepelumab belongs to the class of biological disease-modifying drugs and has shown promise in clinical trials for various inflammatory conditions, particularly those involving elevated eosinophil counts.

Investigated diseases

Progressive Pulmonary Fibrosis with Eosinophilia - A lung condition characterized by the gradual scarring (fibrosis) of lung tissue accompanied by increased levels of eosinophils, a type of white blood cell, in the blood and lungs. The disease causes the lungs to become thick and stiff over time, making it increasingly difficult to breathe. The presence of elevated eosinophils indicates an inflammatory component to the disease process. As the condition progresses, it affects the lungs' ability to transfer oxygen into the bloodstream, leading to shortness of breath, particularly during physical activity. The disease typically develops slowly, with symptoms becoming more noticeable as lung function gradually decreases.