Not yet recruitingRare disease

Study on the Effectiveness of Tezepelumab for Adults with Eosinophilic Granulomatosis with Polyangiitis (EGPA)

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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 eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare disease that causes inflammation of blood vessels, which can lead to damage in various organs. The study will explore the effects of a treatment called Tezepelumab, also known by its code name AMG 157. Tezepelumab is a medication given as a solution for injection and is being compared to a placebo to understand its effectiveness and how it works in the body.

The purpose of the study is to see how well Tezepelumab helps patients with EGPA maintain remission, which means the disease is not active, over a period of 24 weeks. Participants in the study will receive either Tezepelumab or a placebo through subcutaneous injection, which means the injection is given under the skin. The study is designed to be randomised and double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored to assess their response to the treatment. The main goal is to determine the proportion of patients who achieve remission by the end of the study period. Additionally, the study will look at the time it takes for any flare-ups of EGPA to occur and the total time participants remain in remission. This research aims to provide valuable insights into the potential benefits of Tezepelumab for individuals living with EGPA.

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
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the placebo or tezepelumab. This process is called randomization and ensures that the study results are unbiased.
Participants will not know which treatment they are receiving, as the study is double-blinded. This means that neither the participants nor the researchers know who is receiving the active treatment or the placebo.
Step 2
Treatment administration
Participants will receive their assigned treatment through a subcutaneous injection, which is an injection under the skin.
The treatment involves receiving tezepelumab at a dose of 210 mg or a placebo, administered once every four weeks.
Step 3
Monitoring and follow-up
Participants will be monitored regularly throughout the study to assess their health and the effectiveness of the treatment.
The primary goal is to determine if participants achieve remission of their condition by week 24. Remission is defined as having a Birmingham Vasculitis Score (BVAS) of 0 and taking a daily dose of prednisolone of 4 mg or less, without any increase in oral steroids above the baseline dose in the four weeks prior to week 24.
Step 4
End of study
The study is expected to conclude by May 30, 2026. At the end of the study, participants will have a final assessment to evaluate their overall health and the outcomes of the treatment.
Participants will be informed about the results of the study and which treatment they received after the study is completed.

Who can join the trial?

20 criteria

Age between 18 and 75 years old.
All genders can participate.
Must have a condition called eosinophilic granulomatosis with polyangiitis (EGPA).
Must have a history of asthma and a certain level of eosinophils in the blood. Eosinophils are a type of white blood cell.
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Must have at least two of the following:
- Evidence of eosinophilic vasculitis (inflammation of blood vessels).
- Perivascular eosinophilic infiltration or eosinophil-rich granulomatous inflammation (specific types of inflammation).
- Neuropathy (nerve damage).
- Pulmonary infiltrate (substance in the lungs).
- Sino-nasal abnormality (issues with the sinuses or nose).
- Cardiomyopathy (heart muscle disease).
- Glomerulonephritis (kidney inflammation).
- Alveolar haemorrhage (bleeding in the lungs).
- Palpable purpura (small blood spots under the skin).
- ANCA positivity (a specific antibody in the blood).
- Must have had one or more flares (worsening of symptoms) of EGPA in the last 24 months.
- Must have a certain level of eosinophils in the blood at the screening visit.
- Must have non-severe EGPA, meaning the condition does not threaten life or organs.
- Must be on a stable dose of prednisolone (a type of steroid medication) for at least 4 weeks before the study starts.
- If taking immunomodulatory therapy (medications that affect the immune system), the dosage must be stable for 4 weeks before the study starts.
- If taking anti-IL-5/5R therapy (specific medications for severe asthma and EGPA), must have been on treatment for at least 6 months.

Who cannot join the trial?

8 criteria

Patients who do not have a confirmed diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) cannot participate. EGPA is a rare disease that causes inflammation of blood vessels.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults, which typically means individuals aged 18 and older.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are not eligible to participate.
Patients who are currently participating in another clinical trial may not be eligible to join this study.
Patients with certain medical conditions or who are taking specific medications that could interfere with the study may be excluded.
Patients who have a history of severe allergic reactions to any of the study medications or their ingredients cannot participate.
Patients who are pregnant or breastfeeding are not eligible to participate in the study.
Patients with a history of substance abuse or other conditions that could affect their ability to follow the study protocol may be excluded.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
IRCCS Ospedale Auxologico San Luca
Milan, Italy
Responsive
Universita' Degli Studi Di Verona
Verona, Italy

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Investigated drugs

Tezepelumab is a medication being studied for its potential to help people with a condition called eosinophilic granulomatosis with polyangiitis (EGPA). This condition involves inflammation of blood vessels and can affect various organs in the body. Tezepelumab works by blocking a specific protein in the body that is involved in the inflammation process. By doing this, it may help reduce the symptoms of EGPA and help patients maintain remission, which means keeping the disease under control without it getting worse. This study is looking at how effective Tezepelumab is in helping patients with EGPA stay in remission over a period of 24 weeks.

What is already known about the treatment

Tezepelumab – Tezepelumab is administered as an injection under the skin, typically given by a healthcare professional. It is currently being studied in clinical trials for its potential use in treating eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease that causes inflammation of blood vessels. The medication works by blocking a specific protein in the body that plays a key role in the inflammation process, helping to reduce symptoms and maintain remission. Tezepelumab is classified as a monoclonal antibody, which is a type of drug designed to target and neutralize specific proteins in the body.

Investigated diseases

Eosinophilic granulomatosis with polyangiitis (EGPA) – Eosinophilic granulomatosis with polyangiitis is a rare autoimmune disease characterized by inflammation of small to medium-sized blood vessels. It often begins with asthma and allergic rhinitis, followed by an increase in eosinophils, a type of white blood cell. As the disease progresses, it can affect various organs, including the lungs, skin, heart, and nerves. Patients may experience symptoms such as fatigue, weight loss, and muscle and joint pain. The disease can lead to the formation of granulomas, which are small areas of inflammation, and can cause damage to affected tissues. The progression and severity of symptoms can vary widely among individuals.