Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Inducible Urticaria (CIndU) to assess if it is safe and improves reactions to known CIndU triggers.

This research study is testing a new oral medicine called EP262 for adults who have a skin condition known as Chronic Inducible Urticaria, or CIndU. People with CIndU get itchy rashes and bumps on their skin after being exposed to certain triggers, such as cold, heat, pressure, or sunlight. The main goal of this study is to find out if EP262 is a safe treatment and if it can help reduce these skin reactions caused by the triggers. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. It will take place at several different hospitals or clinics.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Escient Pharmaceuticals Inc.

Enrolment target

Start

04 Dec 2023

Chronic Inducible Urticaria

What is this study about?

This study is focused on a skin condition called Chronic Inducible Urticaria, or CIndU for short. If you have CIndU, you might experience itchy rashes, hives, or swellings on your skin when you’re exposed to specific things. For example, some people react to cold temperatures, others to pressure on their skin, or even sunlight. These reactions can be uncomfortable and affect daily life.

Researchers are investigating a new medicine, an oral tablet called EP262, to see if it can help people with CIndU. The main purpose of this study is to check two important things: first, if taking EP262 is safe for people, and second, if it can reduce the skin reactions when you come into contact with your triggers. By understanding this, doctors hope to find better ways to manage CIndU for those who live with it.

This particular study is an early-stage trial. This means it’s one of the first times this new medicine is being given to people. Studies like these are really important steps in understanding how a new medicine works and if it could be a helpful treatment option in the future. The study will involve several different clinics or hospitals working together.

Key takeaways

This study is for adults with Chronic Inducible Urticaria (CIndU).
It's testing a new oral medicine called EP262.
The main goals are to check if EP262 is safe and helps reduce skin reactions.
This is an early-stage study, meaning the medicine is new.
You can withdraw from the study at any time.
The study takes place at multiple locations.

Who may be eligible?

To join this study, you need to be an adult, meaning you are 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

Most importantly, you must have Chronic Inducible Urticaria (CIndU). This means that you experience skin reactions like hives, rashes, or swelling after being exposed to a specific trigger, such as cold, pressure, or heat. The doctors and nurses running the study will check your medical history and do some tests to make sure you meet all the necessary requirements to participate safely.

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 18 years old or older?
Do you have a diagnosis of Chronic Inducible Urticaria (CIndU)?
Are you able to take medicine by mouth?
Are you willing to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, EP262, as an oral tablet. You'll need to attend several appointments at the clinic for check-ups. During these visits, the study team will monitor your health, ask how you're feeling, and assess how your CIndU symptoms are responding to the medicine. They will also perform physical examinations and collect blood samples. You will be told exactly how long you need to take the medicine and how often you need to visit. The total duration of your involvement in the study, including follow-up, will be explained to you before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For benefits, you might find that EP262 improves your CIndU symptoms, and you would be helping researchers learn more about new treatments. However, there's no guarantee the medicine will help you, and you might experience side effects. These could range from mild to more serious, and the study team will explain all known or potential risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Netherlands
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Unverified
Spain

Common questions

What is Chronic Inducible Urticaria (CIndU)?

CIndU is a skin condition where you get itchy rashes or hives when exposed to specific triggers like cold, pressure, or heat.

What is EP262?

EP262 is a new oral medicine being tested to see if it can help adults with CIndU.

Is this medicine approved for CIndU?

No, this is an early-stage clinical trial, meaning the medicine is still being tested and is not yet approved or available to the public.

How long will I be in the study?

The exact duration will be explained by the study team, including how long you take the medicine and how many follow-up visits are needed.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your medical care.