A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria.
This research is testing a new medicine, EVO756, for adults who have severe, ongoing hives, also known as chronic spontaneous urticaria. This condition causes itchy, red welts on the skin that appear without a clear cause. The study is trying to find out if EVO756 is safe and how well different amounts of the medicine work to reduce these symptoms compared to a dummy pill (placebo). Participants won't know if they are receiving the actual medicine or the placebo, and neither will the study doctors. The main goal is to see how much improvement there is in symptoms like itching and rash after 12 weeks of treatment.
At a glance
What is this study about?
This study is a medical research project looking into a new treatment called EVO756 for a skin condition known as chronic spontaneous urticaria. This is a type of long-lasting hives where itchy, red, and swollen patches appear on the skin without an obvious reason. For some people, these hives can be quite severe and impact their daily lives.
The main purpose of this study is to see if EVO756 can help reduce the symptoms of these severe hives, like itching and rash. Researchers also want to find the safest and most effective dose. To do this, they will compare different doses of EVO756 against a 'dummy' treatment, called a placebo, which looks just like the real medicine but contains no active ingredients. This helps them understand if any changes are truly due to the medicine.
This is a 'Phase II' study, which means it’s an early stage of testing new medications. It's about exploring whether the medicine works and finding the right dose, rather than confirming it as a widely used treatment. The information gathered from studies like this is really important for developing new ways to help people living with challenging conditions.
Key takeaways
- This study evaluates a new medicine (EVO756) for severe, ongoing hives.
- It aims to find the safest and most effective dose.
- Participants will receive either the new medicine or a dummy treatment.
- It is an early-stage study (Phase II) to see if the medicine works.
- Your health and symptoms will be carefully monitored throughout the study.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part. The study is open to both men and women.
The most important thing is that you have moderate to severe chronic spontaneous urticaria. This means your hives are ongoing, and are bothering you quite a lot, even with any medication you might currently be taking for them. The study doctors will have specific ways to measure if your hives are severe enough to qualify.
- Are you 18 years old or older?
- Do you have ongoing, severe hives (chronic spontaneous urticaria)?
- Are your hives still causing problems despite your current treatments?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be given either the new medicine (EVO756) or a dummy treatment (placebo). You won't know which one you're getting, and neither will your study doctor – this is to make sure the results are fair.
The study will involve regular visits to the clinic over several weeks. During these visits, doctors will check your general health, assess your hives symptoms, and ask you about any side effects you might be experiencing. These assessments usually involve some questionnaires or scales to help measure how your symptoms are changing. You will be taking the study medication for a certain period, and there will be follow-up appointments even after you've finished taking the medicine to see how you're doing. The exact number of visits and the total length of your participation will be explained in detail by the study team.
Potential risks and benefits
Locations (6)
- —Poland
- —Germany
- —Italy
- —Hungary
- —Bulgaria
- —Spain
Common questions
What exactly is chronic spontaneous urticaria?
It's a skin condition where you get ongoing, itchy hives (red, raised welts) that appear without a clear cause, lasting for more than six weeks.
What does 'double-blind' mean?
It means neither you nor the study doctors will know if you're receiving the actual new medicine or a dummy treatment, to keep the results fair.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real medicine but doesn't contain any active drug. It helps compare the new medicine's effects.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication or the study-related visits and tests. Any travel costs may also be covered, but you should ask the study team about this.
How long will I be in the study?
The study collects information for at least 12 weeks of treatment, but your total involvement, including follow-up visits, could be longer. The study team will give you the exact timeline.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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