Active not recruitingPHASE4INTERVENTIONAL

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

This study is investigating a long-term treatment for children and young people aged 6 to 14 who have moderate to severe eczema (atopic dermatitis). Participants will receive a medicine called dupilumab (Dupixent®) for about two years. The main goal is to see how this medicine affects the skin's protective outer layer, known as the skin barrier. Researchers will measure changes in the skin barrier before and after a special skin test to understand if dupilumab helps improve it. The study will last for a total of about two years and three months, including a short check-up period before starting treatment and a follow-up after the treatment ends.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Sanofi

Enrolment target

Start

22 Feb 2024

Estimated completion

19 May 2027

Dermatitis Atopic

What is this study about?

This study is looking into how a particular medicine, dupilumab (also known as Dupixent®), works over a long period – specifically, two years – for young people aged 6 to 14 who have moderate to severe eczema. Eczema can make the skin very dry, itchy, and sometimes broken. This happens because the skin's natural protective layer, called the skin barrier, isn't working as well as it should.

The main aim of this study is to understand if dupilumab helps to improve this skin barrier. A healthy skin barrier is important because it keeps moisture in and harmful things out, which can reduce eczema flare-ups and improve overall skin health. The researchers will be measuring how much water the skin loses (a sign of how well the barrier is working) before and after gently removing a very thin layer of skin cells with a special tape. This helps them see if the medicine is making the skin barrier stronger and more effective.

Participants will receive Dupixent® throughout the study, following the usual approved way it's given. By carefully observing these changes over two years, the researchers hope to learn more about the long-term benefits of dupilumab for children and teenagers with eczema, potentially leading to better treatment options in the future.

Key takeaways

This study is for children (6-14 years old) with moderate to severe eczema.
It investigates the long-term effects of dupilumab (Dupixent®) on the skin's protective barrier.
Participation involves two years of treatment and regular clinic visits.
Study measurements include special skin tests to check skin barrier health.
The total time committed to the study is about 2 years and 3 months.
The aim is to learn more about how dupilumab helps improve eczema in young people.

Who may be eligible?

To be considered for this study, children must be between 6 and under 12 years old if they are new to the study. If they have taken part in a previous dupilumab study (called PELISTAD), they can be up to under 15 years old. All participants must have been diagnosed with eczema for at least one year before joining.

Their eczema needs to be moderate to severe, with active patches on their arms or legs (and possibly their body). They also need to have an area of healthy-looking skin near an eczema patch for some of the skin tests. It's important that they weigh at least 15 kg (about 2 stone 5 pounds).

However, some things would mean a child couldn't join. This includes having other skin conditions that might make it hard to assess their eczema, or if their eczema patches are too broken, oozing, or bleeding for the skin tests. Children who are allergic to dupilumab or any of its ingredients, or who have certain eye problems, would also not be able to take part.

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.

Is my child aged between 6 and under 12 (or under 15 if previously in the PELISTAD study)?
Does my child have a confirmed diagnosis of moderate to severe eczema?
Does my child weigh at least 15 kg?
Does my child's skin have an area of healthy-looking skin near an eczema patch?
Is my child able and willing to attend all study visits and follow instructions?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part, the study will last about 2 years and 3 months in total. It starts with a screening period of up to 4 weeks to check if you're suitable. Once accepted, treatment with dupilumab (Dupixent®) will begin and will continue for 104 weeks (about two years).

During this time, you'll have regular visits to the clinic for assessments and to receive your medicine. The study requires you to avoid putting any other creams or ointments on the specific areas being tested unless absolutely necessary for comfort. After the two-year treatment period, there will be a 4-week follow-up period, which includes a final phone call at the very end to check in on how you're doing. Altogether, this means you'd be involved with the study for up to 112 weeks.

Potential risks and benefits

Taking part in a study like this means you might be among the first to benefit from detailed, long-term monitoring of a known eczema treatment, which could lead to improvements in your skin barrier. However, there are potential risks, just like with any medicine or study procedure. Dupilumab can have side effects, and some of the skin tests might cause mild, temporary discomfort. You would be fully informed about these before deciding to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (4)

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

National Jewish Health Medical Center- Site Number : 8400001
Verified postcode
Denver, United States
SSM Health Saint Louis University Hospital- Site Number : 8400006
Verified postcode
St Louis, United States
NYU Langone Medical Center- Site Number : 8400004
Verified postcode
New York, United States
Investigational Site Number : 8260001
Verified postcode
Sheffield, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to understand how dupilumab affects the skin's protective layer (skin barrier) in children and teenagers with eczema over a long period.

How long will the study last?

The study will last about 2 years and 3 months for each participant, including screening and follow-up.

What is dupilumab (Dupixent®)?

Dupilumab is a medicine approved to treat moderate to severe eczema in children and adults, helping to reduce inflammation and improve skin symptoms.

Will I need to stop using my usual eczema creams?

You might need to avoid applying other topical creams on specific areas of your skin that are being tested throughout the study, unless absolutely necessary for comfort.

Who can take part in this study?

Children aged 6 to under 12 (or up to under 15 if they were in a previous study) with moderate to severe eczema, who weigh at least 15 kg, may be eligible.