Study on the Effects of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany
Gyncentrum Sp. z o.o.	Katowice	Poland
Geomedical Kft.	Budapest	Hungary

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Nuestra Senora De Sonsoles	Avila	Spain
Hospital Del Mar	Barcelona	Spain
Diagnostics And Consultancy Center Sveti Georgi EOOD	Haskovo	Bulgaria
Vita Longa Sp. z o.o.	Katowice	Poland
Medical Center Excelsior OOD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
University Of Debrecen	Debrecen	Hungary
KomplexLabor Kft.	Kecskemet	Hungary
University Of Szeged	Szeged	Hungary
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie	Rzeszow	Poland
Dr Sekowska Leczenie Bolu	Warsaw	Poland
Twoja-Med	Mikolow	Poland
Klinika Osipowicz & Turkowski Sp. z o.o.	Warsaw	Poland
Tfglzvnm Nibv Sue z oejj	Warsaw	Poland
Atnwitxoulg Zo Iwejfwghppct Pvxijuhi Zq Svuyuktyxlswcq Igoaorjuzgoyxq Mqbwewvhbh Pmyhqm Pe Aknawxscrep Duwkir Tawtig Sudq Corhdu Ejip	Razgrad	Bulgaria
Iyuowmah Zizkvuh Ds Bssndandymzxrwdbn	Oświęcim	Poland
Fbgbuvrzax Gklf	Offenbach Am Main	Germany
Gxpnem Uttbqkthxs Fuytgcpyv	Frankfurt	Germany
Hmbupicl Dq Lh Spfre Csul I Sywi Plw	Barcelona	Spain
Uskwosfcbajsqsjivsxcn Eeieo Awe	Essen	Germany
Hwpnborm Uumqqikxihmpc Dd Li Pdtuuuss	Madrid	Spain
Asdoajm Utktq Swnfrmype Ldumwa Dc Beejoht	Bologna	Italy
Hqskubih Vncn dzklppue	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	01.05.2025
Germany	Not yet recruiting	01.05.2025
Hungary	Not yet recruiting	01.05.2025
Italy	Not yet recruiting	01.05.2025
Poland	Not yet recruiting	01.05.2025
Spain	Not yet recruiting	01.05.2025

Trial locations

Investigated drugs:

Placebo

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.

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.

Trial ID:

2024-518786-10-01

Protocol code:

EVO756-CSU001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria

What is this study about?

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