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Study on Dupilumab and Fexofenadine for Treating Indolent Systemic Mastocytosis with Skin Involvement in Patients

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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 the effects of a medication called dupilumab in treating a condition known as indolent systemic mastocytosis with skin involvement. Indolent systemic mastocytosis is a disease where certain cells in the body, called mast cells, build up in the skin and other parts of the body, causing symptoms like itching, skin lesions, and sometimes more severe reactions. The study will compare the effects of dupilumab, which is given as an injection, with a standard treatment using fexofenadine, a common antihistamine taken as a tablet.

The purpose of the study is to see how well dupilumab works compared to fexofenadine in reducing symptoms such as skin lesions, itching, and improving the overall quality of life for people with this condition. Participants in the study will receive either dupilumab or fexofenadine over a period of time, and their symptoms will be monitored to assess the effectiveness of the treatments. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

The study will last for several months, during which participants will have regular check-ups to monitor their symptoms and any changes in their condition. The goal is to gather information on how these treatments can help manage the symptoms of indolent systemic mastocytosis and improve the quality of life for those affected by this disease. This research could provide valuable insights into better treatment options for people living with this condition.

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
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of systemic mastocytosis with skin involvement. This includes evaluating the extent of skin lesions and the intensity of itching.
The assessment also involves completing questionnaires to measure the impact on quality of life and symptoms such as depression and fatigue.
Step 2
Treatment phase
The treatment phase involves administering dupilumab and fexofenadine. Dupilumab is given as a 300 mg solution for injection using a pre-filled syringe.
Fexofenadine is taken orally in the form of 180 mg film-coated tablets. The frequency and duration of administration are determined by the study protocol.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to evaluate the reduction in symptoms such as anaphylaxis, skin lesions, and itching. This includes weekly assessments of symptom frequency and severity.
Quality of life is assessed using specific questionnaires, and blood tests are performed to measure levels of certain substances like tryptase, IL4, and IL13.
Step 4
Completion and follow-up
Upon completion of the treatment phase, a final evaluation is conducted to assess the overall impact of the treatment on symptoms and quality of life.
Follow-up assessments may be scheduled to monitor long-term effects and ensure the well-being of the participant.

Who can join the trial?

11 criteria

The patient must have a diagnosis of **systemic mastocytosis** with a slow course, which means a condition where certain cells in the body grow too much and affect the skin.
The patient must be between the ages of 18 and 65.
The patient must have a moderate additional risk of a disease that affects their quality of life in at least 2 out of 6 specific areas:
The extent of skin lesions, which means how much of the skin is affected. This is measured by the **Body Surface Area (BSA)**, and it should be 30% or more.
The intensity of itching, which is how bad the itching feels. This is measured on a **Visual Analog Scale (VAS)** from 0 to 10, and it should be 3 or more.
The quality of life index, which measures how symptoms affect daily life. This is measured by the **MC-QoL questionnaire**, and the score should be 50 points or more.
The severity of depression, which is measured by the **Hamilton Rating Scale for Depression**, and the score should be 19 or more.
The severity of fatigue, which is how tired the patient feels. This is measured by the **Fatigue Impact Scale**, and the score should be 75 points or more.
The quality of life for patients treated for blood-related diseases, measured by the **EORTC QLQ C30 questionnaire**, and the score should be 83 points or less.
Both male and female patients can participate.
Patients from vulnerable populations can also participate.

Who cannot join the trial?

4 criteria

Patients who have a different condition than systemic mastocytosis with a slow course and involvement of the skin cannot participate. Systemic mastocytosis is a condition where certain cells in the body grow too much and can affect the skin.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not meet the gender requirements for the study cannot participate. The study is open to both males and females.
Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might need special protection or care.

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Verified sites

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Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, Poland
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Uniwersyteckie Centrum Kliniczne
Gdansk, Poland

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Investigated drugs

Dupilumab
is a medication used in this trial to treat indolent systemic mastocytosis with skin involvement. It is being studied to see how effective it is in managing the symptoms of this condition. Dupilumab works by targeting specific pathways in the immune system that are involved in inflammation, which may help reduce symptoms like itching and skin lesions.
Fexofenadine
is a standard antihistamine treatment used in this trial. It is commonly used to relieve allergy symptoms such as runny nose, sneezing, and itching. In this study, fexofenadine serves as a comparison to see how well it manages symptoms of indolent systemic mastocytosis compared to the study drug, dupilumab.

What is already known about the treatment

Dupilumab
Dupilumab is administered as an injection under the skin. It is currently being studied for its effectiveness in treating indolent systemic mastocytosis with skin involvement. This medication is primarily used for conditions like eczema and asthma, and it works by blocking certain proteins in the body that cause inflammation. Dupilumab is classified as a monoclonal antibody, which targets specific molecules to reduce allergic reactions and inflammation.
Fexofenadine
Fexofenadine is taken orally in the form of tablets or liquid. It is a well-established antihistamine used to relieve allergy symptoms such as runny nose, sneezing, and itching. In the context of systemic mastocytosis, it is being compared to dupilumab to evaluate its effectiveness. Fexofenadine works by blocking histamine, a substance in the body that causes allergic symptoms, and is classified as a second-generation antihistamine.

Investigated diseases

Systemic Mastocytosis – This is a condition where there is an abnormal accumulation of mast cells in various tissues, including the skin, bone marrow, and internal organs. It progresses slowly and can lead to symptoms such as skin lesions, itching, and flushing due to the release of substances from mast cells. Over time, individuals may experience more frequent episodes of these symptoms. The involvement of the skin is common, and the extent of skin lesions can vary. The condition can also affect the quality of life, causing fatigue and sometimes depression.