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Study on the Effects of EP262 for Adults with Chronic Spontaneous Urticaria

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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 Chronic Spontaneous Urticaria (CSU), which is a type of hives that appear without a known cause and can be persistent. The study will investigate the effects of a new oral medication called EP262, which is being tested to see if it can help reduce the symptoms of CSU. Participants in the study will receive either the study drug, EP262, or a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment.

The purpose of the study is to evaluate how well EP262 works in reducing the itchiness and number of hives in people with CSU. The study will take place over a period of six months, during which participants will take the medication in capsule form. Throughout the study, participants will be monitored for any changes in their symptoms and any side effects they might experience. The study aims to provide valuable information on the safety and effectiveness of EP262 for treating CSU.

Participants will be asked to visit the study site regularly for check-ups and assessments. These visits will help researchers gather data on the intensity of itching, the number of hives, and any changes in health indicators such as vital signs and laboratory tests. The study is designed to ensure that all participants are closely monitored to maintain their safety and well-being while contributing to the understanding of how EP262 can help manage Chronic Spontaneous Urticaria.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit at the clinical site. During this visit, your eligibility will be confirmed based on criteria such as age and medical history of chronic spontaneous urticaria (CSU).
You will be asked about your current treatment with H1 antihistamines and your symptoms, including itch intensity and number of hives.
Step 2
Randomization
After confirming eligibility, you will be randomly assigned to receive either the study drug EP262 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
Step 3
Treatment phase
During the treatment phase, you will take the assigned medication orally in the form of a capsule. The dosage and frequency will be determined by the study protocol.
You will continue your stable dose of H1 antihistamine as per your local treatment guidelines.
Step 4
Regular assessments
Throughout the study, you will have regular assessments to monitor your health and the effects of the treatment. These assessments will include checking your vital signs, performing electrocardiograms (ECGs), and conducting laboratory tests.
You will also be asked to report any changes in itch intensity, number of hives, and any side effects you may experience.
Step 5
End of treatment
At the end of the treatment period, you will have a final visit to evaluate the overall effects of the study drug compared to the placebo.
The study aims to assess changes in itch intensity and the number of hives, as well as any side effects related to the treatment.

Who can join the trial?

4 criteria

Age between 18 and 80 years old
Have a documented history of chronic spontaneous urticaria (CSU). This means having a condition where hives appear on the skin without a known cause and last for more than six weeks.
Have a UAS7 score of 16 or higher. UAS7 is a tool used to measure the severity of urticaria symptoms over a week.
Currently taking a stable dose of H1 antihistamine. This is a type of medication used to relieve allergy symptoms, and the dose can be up to four times the approved amount according to local guidelines.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with any other significant health condition that might interfere with the study results are excluded.
Pregnant or breastfeeding women cannot take part in the study.
Patients who have used certain medications that might affect the study results within a specific time frame before the study starts are not eligible.
Patients with a history of drug or alcohol abuse within the past year are excluded.
Patients who have had a major surgery within a certain period before the study begins cannot participate.
Patients with a known infection that could affect the study results are not eligible.
Patients who have been diagnosed with cancer within the past five years are excluded, except for certain types of skin cancer.
Patients who have a condition that affects their immune system, making them more prone to infections, cannot participate.

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Verified sites

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

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany

Trial locations

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Investigated drugs

EP262 is a medication being tested to see if it can help people with a condition called Chronic Spontaneous Urticaria, which is a type of hives that appear without a known cause. This medication is being studied to understand if it can reduce the symptoms of this condition, such as itching and the appearance of hives on the skin. The trial aims to compare the effects of EP262 to those of a placebo, which is a substance with no active medication, to see if EP262 provides real benefits to the participants.

Ep262

What is already known about the treatment

EP262 – EP262 is administered orally in the form of a tablet and is currently being studied in clinical trials for its potential use in treating Chronic Spontaneous Urticaria (CSU). This medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for EP262 is to alleviate symptoms associated with CSU, a condition characterized by persistent hives and itching without an apparent cause. At the molecular level, EP262 works by targeting specific pathways in the immune system that are involved in the inflammatory response, helping to reduce the occurrence of hives. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Chronic Spontaneous Urticaria – Chronic Spontaneous Urticaria is a skin condition characterized by the sudden appearance of itchy hives or welts on the skin. These hives can vary in size and may appear anywhere on the body. The condition is termed "spontaneous" because the hives occur without an obvious trigger. The hives can last for more than six weeks and may come and go unpredictably. Itchiness is a common symptom, and the intensity can vary from mild to severe. The condition can persist for months or even years, with symptoms fluctuating over time.