RecruitingPHASE1INTERVENTIONAL

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis

Researchers are conducting a study to evaluate a new oral medicine called SYX-5219 for people with moderate to severe eczema (atopic dermatitis). The main goals are to understand if the drug is safe, how well people tolerate it, and how it's absorbed and processed by the body. The study has three parts: the first two parts involve healthy volunteers receiving single or multiple doses of the drug to see its initial effects. The third part will involve people with eczema receiving the drug or a dummy pill (placebo) for 42 days, to further assess safety and explore if it helps with their condition. This is an early-stage study, meaning it's one of the first times this drug is being tested in humans.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Sitryx Therapeutics Ltd

Enrolment target

149

Start

26 Feb 2025

Estimated completion

30 Sep 2026

Moderate to Severe Atopic Dermatitis

What is this study about?

This research is looking into a new oral medication, SYX-5219, for people who have moderate to severe eczema, also known as atopic dermatitis. Eczema is a common skin condition that causes red, itchy, and inflamed patches. The study aims to understand how safe this new drug is, if people can tolerate taking it, and how the body handles it. This is an important first step in developing new treatments for eczema.

The study is divided into three main parts. The first two parts are for healthy volunteers, where researchers will give them either a single dose or several doses of SYX-5219. This helps them understand the basic safety and how the drug behaves in the body before giving it to people with the condition it's designed to treat. They'll also check if taking the medicine with food changes how it works.

The third part of the study will involve people who currently have moderate to severe eczema. In this part, participants will receive either the study drug or a placebo (a dummy pill with no active medicine) for about six weeks. The researchers will be carefully monitoring their safety and looking for any signs that the drug might be helping with their eczema symptoms, like itching and skin inflammation. This comprehensive approach helps ensure that any potential new treatment is thoroughly evaluated.

Key takeaways

Tests a new oral drug, SYX-5219, for moderate to severe eczema.
First-stage study to check drug safety and how the body handles it.
Involves both healthy volunteers and people with eczema.
Eczema participants will take the drug or a dummy pill for 42 days.
Focuses on safety and initial signs of effectiveness for eczema.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you generally need to be between 18 and 65 years old. For the first two parts, you must be a healthy individual with a body mass index (BMI) within a specific range, and a woman of childbearing potential would need to be using reliable contraception or be sexually abstinent.

For the third part, which focuses on individuals with eczema, you must have a confirmed diagnosis of active moderate to severe eczema for at least six months. This means your eczema should cover at least 10% of your body, have a certain level of severity as assessed by doctors, and you should be experiencing a significant amount of itching. You should also not have a BMI over 40.

You would not be able to participate if you have certain other medical conditions, significant abnormalities in blood tests, or have taken certain medications or supplements recently. The research team will carefully review your medical history to make sure the study is safe for you.

Quick self-check

Are you between 18 and 65 years old?
Do you have a diagnosis of active moderate to severe eczema (at least 6 months)?
Does your eczema cover at least 10% of your body and is it actively itching?
Do you have any significant ongoing medical conditions?
Have you recently taken certain prescription or non-prescription medications?

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 in this study, what you do will depend on which part you are in. If you are a healthy volunteer in Part 1 or 2, you'll likely need to spend some time at the clinic, either for single doses or multiple doses given over a period. This will involve regular checks like blood and urine tests, and monitoring your vital signs such as blood pressure and heart rate. You might also have a 'washout' period between doses.

If you have eczema and join Part 3, you will receive either the study drug (SYX-5219) or a placebo every day for 42 days. During this time, you'll have several visits to the study site for various assessments. These will include check-ups on your safety, such as blood tests and physical examinations, as well as evaluations of your eczema symptoms. After the 42-day treatment period, there will be a follow-up period to ensure your continued well-being. The exact number of visits and the total length of your involvement will be clearly explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. For this study, a potential benefit for participants with eczema is receiving a new treatment that might improve their symptoms, or contributing important information that could help others with eczema in the future. However, there's no guarantee the drug will be effective for you, and you might receive a placebo. Potential risks could include side effects from the study drug, which will be carefully monitored. You will be fully informed of all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Sitryx Clinical Site
Arkansas City, United States· Recruiting
Sitryx Clinical Site
Fremont, United States· Recruiting
Sitryx Clinical Site
Plainfield, United States· Recruiting
Sitryx Clinical Site
Boardman, United States· Recruiting
Sitryx Clinical Site
Philadelphia, United States· Recruiting
Sitryx Clinical Site
Bountiful, United States· Recruiting
Sitryx Clinical Site
Sofia, Bulgaria· Recruiting
Sitryx Clinical Site
Herlev, Denmark· Not yet recruiting
Sitryx Clinical Site
Berlin, Germany· Recruiting
Sitryx Clinical Site
Frankfurt, Germany· Recruiting
Sitryx Clinical Site
Freiburg im Breisgau, Germany· Active not recruiting
Sitryx Clinical Site
Dublin, Ireland· Recruiting

+2 more sites — see the official record for the full list.

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical term for eczema, a common skin condition that causes dry, itchy, and irritated skin.

What is a 'placebo' in a study?

A placebo is a 'dummy' pill that looks like the study drug but contains no active medicine. It helps compare how effective the actual drug is.

Why are healthy volunteers included in the study?

Healthy volunteers help researchers understand the basic safety and how the drug behaves in the body before it's given to people with the condition it aims to treat.

How long will I need to take part if I have eczema?

If you have eczema, you would take the study medication or placebo daily for 42 days, followed by a period of observation and follow-up visits.

Can I leave the study if I change my mind?

Yes, your participation is voluntary, and you can withdraw from the study at any time without it affecting your usual medical care.

How to find out more

Sitryx Therapeutics

info@sitryx.com +44 (0)1865 648401 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.