Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND)

This research study is for adults in the UK who have eczema on their hands that is moderate to severe and needs more than just creams. It's called the ADHAND study and is testing a new medicine, tralokinumab, which is given as an injection every two weeks. Some participants will receive the active medicine, while others will get a 'dummy' injection (a placebo) that looks the same but contains no medicine. This helps researchers understand if the new medicine is actually making a difference. The main aim is to find out if tralokinumab can clear up or mostly clear up hand eczema after 16 weeks, and to make sure it's safe to use. This kind of study helps us find better ways to treat conditions like hand eczema.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

LEO PHARMA A/S

Enrolment target

191

Start

30 Jan 2024

Atopic dermatitis and moderate-to severe atopic hand eczema

What is this study about?

Imagine constantly dealing with painful, itchy eczema on your hands. It can make everyday tasks difficult and impact your quality of life. This research study, called ADHAND, is looking for a new and better way to help people who have moderate to severe eczema specifically on their hands. This type of eczema is sometimes called atopic hand eczema, and it's when the eczema is severe enough that creams and ointments aren’t enough, and doctors might consider stronger treatments.

The study is testing a medication called tralokinumab. This isn't a new medicine for all types of eczema, but this specific study wants to see how well it works just for hand eczema. The researchers want to find out if this medicine can significantly improve or even clear up the eczema on people's hands after about four months of treatment, and if it's safe to use. By comparing it to a 'dummy' treatment (a placebo), they can be sure that any improvements are truly due to the active medicine.

Finding new and effective treatments for hand eczema is important because it can be a really challenging condition to live with. If this study shows that tralokinumab is safe and works well, it could offer a new option for many people who are currently struggling with their hand eczema.

Key takeaways

This study evaluates a potential new injection treatment for severe hand eczema.
It compares the new drug (tralokinumab) to a dummy treatment (placebo).
The main goal is to see if hand eczema significantly improves or clears after 16 weeks.
Participation involves regular clinic visits for injections and assessments.
Adults (18+) with moderate to severe atopic hand eczema are eligible.

Who may be eligible?

This study is looking for adults aged 18 years and older. There's no upper age limit, and it's open to both men and women.

To be considered for this study, you must have eczema that is specifically on your hands, and it needs to be what doctors would call 'moderate to severe'. This means it's causing you significant problems and your doctor feels you might need stronger treatment than just creams or ointments. Importantly, it must be 'atopic' hand eczema, which is a specific type of eczema.

There will be other specific medical checks to make sure the study medication is safe for you. The study team will review your medical history to make sure you fit all the criteria. If you're currently managing your hand eczema well with your existing treatments, this study might not be the right fit for you.

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 eczema specifically on your hands?
Is your hand eczema considered moderate to severe by your doctor?
Has your doctor suggested stronger treatments because creams aren't enough?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine, tralokinumab, or a dummy treatment (placebo). Both are given as an injection under the skin every two weeks. You would have regular visits to the clinic over many months. At these visits, doctors and nurses would check your hand eczema, ask you about how you're feeling, and carry out various tests like blood samples. This helps them understand how the treatment is working and monitor your health. You would be followed up for a period after the main treatment phase to ensure your well-being. The exact number of visits and the total length of time you'd be in the study would be explained in detail by the study team, but typically these kinds of studies involve several months of active participation and follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might improve your hand eczema before it's widely available. However, there are also potential risks, such as side effects from the study medication or dummy treatment, and the time commitment required for clinic visits. As with any medical study, there's always a chance the treatment might not work for you, or you might receive the placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Sweden
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Unverified
France
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Unverified
Czechia
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Unverified
Germany
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Unverified
Portugal
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Unverified
Belgium
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Unverified
Netherlands
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Unverified
Spain
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Unverified
Poland

Common questions

What is tralokinumab?

Tralokinumab is a medicine that aims to calm down the body's immune system, which is overactive in people with eczema, to help reduce inflammation and improve skin condition.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real drug's effects accurately.

How is the treatment given?

The treatment, whether the active medicine or the placebo, is given as an injection just under the skin every two weeks.

How long will the study last?

The main part of the study where your hand eczema is regularly assessed for improvement is 16 weeks (about 4 months), but the total time you are involved, including follow-up, could be longer.

Can I receive this treatment if I'm not in the study?

Tralokinumab is not currently approved or widely available specifically for hand eczema, which is why this study is being done to gather more information.