Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

This research study is looking into a new medicine called EP262 for people who suffer from chronic spontaneous urticaria (CSU). This condition causes persistent itchy hives without an obvious trigger. The main goal of the study is to see how well EP262 works at reducing both the intensity of the itching and the number of hives someone gets, compared to a placebo (a dummy medicine with no active ingredients). Researchers will also be checking for any side effects and how safe the new medicine is. By comparing EP262 to a placebo, doctors can learn if the new medicine is effective and help improve treatment options for people living with CSU.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Escient Pharmaceuticals Inc.

Enrolment target

Start

28 Dec 2023

Chronic Spontaneous Urticaria

What is this study about?

This study is about understanding how a new medicine, called EP262, might help people who have chronic spontaneous urticaria, also known as chronic hives. If you have this condition, you'll know it means you get itchy red bumps or welts on your skin that appear suddenly and last for more than six weeks, often without a clear reason.

The main aim of this research is to see if EP262 can make a real difference to how much itching you experience and how many hives you get. To do this, some people in the study will receive EP262, while others will get a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers fairly compare the new medicine's effects. The study is 'double-blind,' meaning neither you nor your doctor will know if you're taking EP262 or the placebo, which helps keep the results unbiased.

Beyond checking improvements in itching and hives, the researchers will also be carefully monitoring for any side effects and looking at other health markers like vital signs (such as blood pressure and heart rate) and blood tests. This detailed approach helps them understand if EP262 is not only effective but also safe for people to use.

Key takeaways

This study is testing a new medicine called EP262 for chronic hives.
It aims to reduce itching and the number of hives.
Some participants will receive EP262, others a dummy medicine (placebo).
Researchers will also check for side effects and safety.
Participants must be aged 18 or over and have chronic spontaneous urticaria.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate as long as they meet other health requirements.

This study is open to everyone, regardless of whether you are male or female. The main requirement is that you have a diagnosis of chronic spontaneous urticaria.

There might be other health conditions or medications that could prevent you from joining, as the researchers need to ensure the study is safe for everyone involved and that the results are clear. Your doctor will be able to discuss these with you in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have chronic spontaneous urticaria (chronic hives)?
Are you able to attend regular clinic visits?
Are you willing to potentially receive either the study medicine or a placebo?
Are you comfortable with regular health checks, including blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several scheduled visits to the study clinic. During these visits, the research team will perform various assessments. These will likely include checking your symptoms, such as how much you're itching and how many hives you have, as well as asking you questions about your general health. You will be given either the study medicine, EP262, or a placebo, which you will take as directed.

The study also includes assessments like blood tests, checking your blood pressure and heart rate (vital signs), and possibly electrocardiograms (ECGs) to monitor your heart health. These checks help the researchers understand how the medicine is affecting your body. You will have follow-up appointments after you stop taking the study medicine to see how you are doing. The total length of your participation in the study, from start to finish, will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine might not work for you. It's also possible you could receive the placebo and not the active drug. You have the fundamental right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Germany
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Unverified
Spain
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Unverified
Netherlands

Common questions

What is chronic spontaneous urticaria (CSU)?

CSU, also known as chronic hives, is a condition where you get itchy red bumps or welts on your skin that appear suddenly and last for more than six weeks, often without a clear cause.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but has no active ingredients. It's used in studies to help researchers compare the new medicine's effects fairly.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine (EP262) or the placebo. This helps ensure the study results are fair and unbiased.

Will I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related care and medication are typically provided at no cost to you.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your current or future medical care. Your decision will always be respected.