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Study on the Effects of EVO756 in Adults with Moderate to Severe 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, which is a type of hives that appear without a known cause and can be moderate to severe. The study will evaluate a treatment called EVO756 Potassium, which is being tested in tablet form. Participants in the study will receive either the EVO756 Potassium or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to assess how effective and safe EVO756 Potassium is at different dose levels. The study will last for up to 12 weeks, during which participants will take the medication orally. Throughout the study, participants will be monitored to see how their symptoms change over time. The study aims to find out if EVO756 Potassium can reduce the severity of the hives and improve the quality of life for those affected by this condition.

Participants will be asked to keep track of their symptoms and report any changes they experience. The study will help determine the best dose of EVO756 Potassium and provide valuable information on its potential as a treatment for Chronic Spontaneous Urticaria. This research is important for developing new ways to manage and treat this challenging 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
Beginning of the trial
Upon joining the study, you will be randomly assigned to receive either the study medication, EVO756 potassium, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
The study is designed to be 'double-blind,' meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.
Step 2
Medication administration
You will take the assigned tablet orally. The dosage and frequency will be determined by the study protocol, which will be explained to you in detail by the study team.
The duration of the medication administration is planned for up to 12 weeks, during which you will be monitored regularly.
Step 3
Regular assessments
Throughout the study, you will have regular assessments to monitor your condition and any changes. These assessments will include measuring the Urticaria Activity Score (UAS7), which evaluates the severity of your symptoms over a week.
Assessments will occur at specific intervals: Weeks 1, 2, 4, 8, and 12. These will help track the mean and percent change in your symptoms from the start of the study.
Step 4
End of the trial
At the end of the 12-week period, a final assessment will be conducted to evaluate the overall change in your condition.
The primary goal is to measure the mean change in your UAS7 score from the beginning to the end of the study. Secondary goals include evaluating other symptom scores and the proportion of participants achieving specific symptom reductions.

Who can join the trial?

5 criteria

Must be a male or female who is at least 18 years old.
Must be able to provide written informed consent, which means you agree to participate after understanding the study details.
Must have a confirmed diagnosis of Chronic Spontaneous Urticaria (CSU) for at least 3 months and have not responded well to H1 antihistamines (a type of allergy medicine).
Must have a Urticaria Activity Score (UAS7) of 16 or higher on Day 1. This score measures the severity of your urticaria symptoms over a week. You need to have completed the score entries for at least 4 out of the 7 days before Day 1.
If you are taking H1 antihistamines, you must be on a stable regimen for 4 weeks before Day 1 and continue this regimen during the study.

Who cannot join the trial?

10 criteria

Patients with any other **serious health conditions** that could interfere with the study.
Patients who have had a **severe allergic reaction** to any medication in the past.
Patients who are currently participating in another clinical trial.
Patients who have used any investigational drug within the last 30 days.
Patients who are pregnant or breastfeeding.
Patients with a history of **drug or alcohol abuse** within the past year.
Patients who have a **compromised immune system**, which means their body has a reduced ability to fight infections.
Patients who have had a **major surgery** within the last 3 months.
Patients with **uncontrolled high blood pressure** or other significant heart problems.
Patients who have a history of **cancer** within the last 5 years, except for certain skin cancers.

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Verified sites

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

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Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Clínica de asma y alergia Dres. Ojeda
Madrid, Spain

Trial locations

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Investigated drugs

EVO756 is a medication being tested to see how well it works for people with moderate to severe chronic spontaneous urticaria, which is a condition that causes hives and itching without a known cause. The study is looking at different amounts of this medication to find out how effective it is in reducing the symptoms of this condition. Participants in the trial will receive this medication to see if it helps improve their symptoms compared to those who do not receive it.

Placebo

What is already known about the treatment

EVO756 – EVO756 is administered in a form that is not specified in the provided data, but it is being studied for its effectiveness in treating moderate to severe chronic spontaneous urticaria, a condition characterized by persistent hives without an apparent cause. Currently, EVO756 is in the clinical trial phase, where its safety and efficacy are being evaluated compared to a placebo. The main therapeutic indication for EVO756 is to alleviate symptoms associated with chronic spontaneous urticaria. While the exact mechanism of action at the molecular level is not detailed in the data, it is being investigated for its potential to reduce the severity of urticaria symptoms. EVO756 falls under the pharmacological classification of investigational drugs, as it is still undergoing clinical trials to determine its effectiveness and safety for medical use.

Investigated diseases

Chronic Spontaneous Urticaria – Chronic Spontaneous Urticaria is a skin condition characterized by the spontaneous appearance of hives, which are raised, itchy welts on the skin. These hives can vary in size and may appear and fade repeatedly as the condition progresses. The condition is termed "chronic" because it persists for six weeks or longer without an identifiable external trigger. The hives are often accompanied by angioedema, which is swelling beneath the skin, particularly around the eyes and lips. The severity of symptoms can fluctuate, with periods of intense itching and discomfort. The exact cause of Chronic Spontaneous Urticaria is not well understood, but it is believed to involve the immune system.