Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety deucravacitinib in patients with chronic hand eczema

This research study is looking for volunteers with ongoing hand eczema to test a new medicine named deucravacitinib. Hand eczema can be very uncomfortable, and we're hoping this new treatment might offer relief. The study is designed to see if this medicine can effectively improve your eczema symptoms and reduce how severe it is, specifically looking at changes after 16 weeks. We also want to understand if it's safe to use and how participants feel about their own symptoms and quality of life while on the treatment. Participants will be given either the new medicine or a dummy pill, and neither they nor their doctors will know which one they are receiving until the study is over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

Start

09 Nov 2023

Chronic Hand Eczema

What is this study about?

This study is about a problem many people face: chronic hand eczema. This is a type of eczema that affects your hands and doesn't go away easily. It can make your hands dry, itchy, red, and sometimes cracked and painful. We are exploring a new medicine called deucravacitinib to see if it can help people who suffer from this condition. This medicine is still being tested and is not yet approved for general use. The study is a 'Phase II' trial, which means we are still in the earlier stages, trying to find out if the medicine works well enough and is safe enough to continue with larger studies.

The main goal of this particular study is to see how many people taking deucravacitinib experience a significant improvement in their hand eczema after 16 weeks. We'll be using a standard system to measure improvements, where a doctor assesses the eczema and gives it a score. We want to see if the medicine can reduce the eczema to a very mild or clear state. We will also compare the results to people who receive a 'dummy' pill (called a placebo) to understand the true effect of the new medicine.

But it's not just about how the eczema looks. We also want to understand how people feel. So, the study will look at how the eczema affects your daily life, your comfort, and your overall quality of life. We'll also be carefully monitoring for any side effects to make sure the medicine is safe. Scientists will also take a closer look at skin samples to understand how the medicine might be working at a cellular level, by studying various markers in the skin.

Key takeaways

Researchers are testing a new medicine (deucravacitinib) for chronic hand eczema.
The study aims to see if it improves eczema and is safe over 16 weeks.
Participants will receive either the new medicine or a dummy pill.
It's open to adults aged 18 and over with long-lasting hand eczema.
Your journey will involve regular clinic visits and assessments.
Participation could benefit you and future patients, but there are potential risks.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years of age or older. There is no upper age limit, so people of all adult ages can potentially take part. The study is open to everyone, regardless of whether you are male or female.

The most important requirement is that you must have chronic hand eczema. This means your hand eczema has been a long-term problem for you, rather than a new or short-term flare-up. Doctors will check your medical history and examine your skin to make sure your eczema fits the study's specific criteria.

There might be other health conditions or medicines that would prevent someone from joining, to ensure their safety. This is standard practice in all clinical trials to protect participants. The study team will discuss all these details with you to see if you are a good fit.

Quick self-check

Are you 18 years old or older?
Do you have hand eczema that has been a long-term problem for you?
Are you able to attend clinic appointments regularly for about 16 weeks?
Are you willing to potentially take a dummy pill instead of the active medicine?
Are you comfortable with doctors examining your hands and possibly taking skin samples?

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, you'll be randomly assigned to either receive the new medicine, Sotyktu (deucravacitinib), or a matching dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving – this helps make the study fair and scientific. You'll need to take tablets regularly as instructed.

Throughout the study, you will have several visits to the clinic over a period of 16 weeks. These visits will involve assessments by the study doctor to check your hand eczema, such as taking pictures and performing physical examinations. You'll also be asked to complete questionnaires about how your eczema affects your life and how you feel about your symptoms. Blood tests and skin samples (biopsies) might also be taken to help the researchers understand how the medicine is working and to monitor your health. Your safety will be closely monitored at all times.

Potential risks and benefits

There's a chance you might experience benefits from taking part, such as an improvement in your hand eczema symptoms if you receive the active medicine. You will also be playing an important role in helping to find new treatments for chronic hand eczema, which could benefit many people in the future. However, as with any new medicine, there are potential risks, including side effects that could be mild or more serious. The study team will explain all known potential side effects to you. There is also no guarantee that your eczema will improve. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is 'chronic hand eczema'?

Chronic hand eczema is a type of eczema that affects your hands and has lasted for a long time or keeps coming back, making your hands dry, itchy, red, or cracked.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers understand the true effects of the new medicine.

Will I know if I'm getting the real medicine or the placebo?

No, during the study, neither you nor your doctor will know whether you are receiving the new medicine or the placebo. This is to keep the study fair.

How long will I be in the study?

The main part of the treatment and assessment period for this study will last for 16 weeks, which is about four months.

What does a 'Phase II' study mean?

A Phase II study means we are in an earlier stage of testing a new medicine. We're trying to find out if it works well and is safe enough to continue being tested in larger groups of people.