Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding

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What is this study about?

This clinical trial is focused on studying a disease called ANCA-associated vasculitis, which is a condition where the body’s immune system mistakenly attacks its own blood vessels, leading to inflammation. In this study, the specific type of ANCA-associated vasculitis being examined involves severe bleeding in the lungs, known as pulmonary hemorrhage. The treatment being tested is a medication called Idefirix, which contains an active substance named imlifidase. This medication is given through an intravenous infusion, meaning it is administered directly into the bloodstream.

The purpose of the study is to evaluate how effective Idefirix is when used alongside the standard care for patients with severe ANCA-associated vasculitis and lung bleeding. Participants in the study will receive either Idefirix or a placebo, in addition to the usual treatments for their condition. The study will monitor how quickly the levels of ANCA antibodies in the blood decrease after treatment, as well as other health outcomes such as lung and kidney function, and overall safety.

Throughout the study, researchers will observe participants for any changes in their condition, including improvements in lung function and any potential side effects. The study aims to provide valuable information on the potential benefits and safety of using Idefirix in treating this serious form of vasculitis. The trial is expected to continue until mid-2026, with recruitment of participants starting in 2024.

1 joining the study

Upon joining the study, you will provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You will be assessed to ensure you meet the study’s criteria, such as having a clinical diagnosis of ANCA-associated vasculitis with specific symptoms.

2 initial assessment

A detailed medical evaluation will be conducted, including a review of your medical history and current health status.

Tests may include blood tests to measure ANCA titers and imaging studies like chest X-rays or CT scans to assess lung involvement.

3 treatment administration

You will receive the study medication, Idefirix, which contains the active substance imlifidase. This will be given as an intravenous infusion, meaning it is administered directly into your vein.

The goal is to observe the effect of imlifidase on your condition, particularly its ability to reduce ANCA levels within 24 hours.

4 monitoring and follow-up

Your health will be closely monitored throughout the study. This includes regular check-ups and tests to track your response to the treatment.

The study will assess various outcomes, such as changes in ANCA levels, lung and kidney function, and any side effects you may experience.

5 completion of study

At the end of the study period, a final assessment will be conducted to evaluate your overall health and the effects of the treatment.

You will receive information about the study’s findings and any further steps regarding your health care.

Who Can Join the Study?

Must have a new or previous clinical diagnosis of ANCA-associated vasculitis, which includes conditions like granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Must have an ANCA titer (a type of blood test) of 50 or higher, measured no more than 14 days before joining the study.
Must have pulmonary hemorrhage (bleeding in the lungs) due to active vasculitis, confirmed by:
- A chest x-ray or CT scan showing specific lung patterns.
- No other explanation for lung issues, like fluid overload or infection.
- At least one of the following:
  - Evidence of bleeding in the lungs from a bronchoscopy (a test using a camera to look inside the lungs).
  - Coughing up blood.
  - Unexplained low red blood cell count (anemia) or a drop in hemoglobin levels.
  - Acute respiratory distress syndrome (ARDS), a severe lung condition.
Must provide written informed consent before any study-related procedures.
Must be willing and able to follow the study protocol.
For female participants: Must be confirmed as post-menopausal, meaning no menstrual periods for at least 12 months.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to the study medication or its ingredients.
Patients with a history of drug or alcohol abuse within the past year.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of non-compliance with medical treatments.
Patients with severe liver or kidney disease.
Patients with active infections that require treatment.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	17.05.2024

Trial locations

Investigated drugs:

Imlifidase

Imlifidase is a medication being studied for its potential to help treat a condition called ANCA-associated vasculitis, which can cause severe inflammation in blood vessels. In this trial, researchers are looking at how well imlifidase works when combined with the usual treatments for this condition. The goal is to see if it can help reduce the severity of symptoms, especially in cases where there is bleeding in the lungs.

Investigated diseases:

Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis with severe diffuse alveolar hemorrhage – This disease is a type of vasculitis, which involves inflammation of blood vessels. It is associated with the presence of ANCA, which are antibodies that mistakenly target and attack certain proteins in the body. In this condition, the inflammation primarily affects small to medium-sized blood vessels, leading to damage. The severe form includes diffuse alveolar hemorrhage, where bleeding occurs in the tiny air sacs of the lungs. This can result in coughing up blood and difficulty breathing. The disease progresses with episodes of inflammation and bleeding, which can cause significant lung damage over time.

Trial ID:

2024-516727-13-00

Protocol code:

ImlifidARDSe.01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding

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