Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (aged 2 to 11 years) with Moderate-to-Severe Atopic Dermatitis

This research study is for children aged 2 to 11 years old who suffer from moderate to severe eczema, also known as atopic dermatitis. It's looking at a new potential medicine called Nemolizumab. The main goals are to understand how the medicine moves through a child's body, its safety, and how effective it is in treating eczema symptoms. This is an early-stage study (Phase II) which means researchers are actively exploring if it could be a helpful treatment. Finding new and better ways to manage eczema in children is really important, as it can be a challenging condition for them and their families. This study will help us learn more about Nemolizumab's potential.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Galderma S.A.

Enrolment target

100

Start

15 Oct 2024

Atopic Dermatitis

What is this study about?

Imagine constantly itching, having red, inflamed skin, and feeling uncomfortable – that's what many children with eczema, or atopic dermatitis, go through. This study is exploring a new medicine called Nemolizumab that might help these children. It's designed for children aged 2 to 11 who have eczema that is moderate to severe, meaning it significantly affects their daily life.

The main aim of the study is to understand how Nemolizumab works in young bodies. This involves checking how much medicine is in the blood at different times and how the body processes it. Another very important part is looking at how safe the medicine is. Researchers will carefully monitor for any side effects, whether they are minor or more serious, to make sure the medicine is well-tolerated.

Alongside safety, the study will also assess how effective Nemolizumab is at improving eczema symptoms. Doctors will look at changes in the skin, such as how much redness and itching there is, using standard ways to measure eczema severity. By gathering all this information on safety, how the body handles the medicine, and its effects on eczema, researchers hope to determine if Nemolizumab could be a valuable new treatment option for children.

Key takeaways

This study is for children aged 2-11 with moderate to severe eczema.
It's testing a new medicine called Nemolizumab.
The study will check the medicine's safety, how it works in the body, and its effect on eczema.
Participation involves regular clinic visits over about a year.
Potential benefits include access to a new treatment, but there are also potential risks from side effects.

Who may be eligible?

This study is specifically looking for children between 2 and 11 years old. Both boys and girls are welcome to take part.

To be considered, your child must have moderate to severe atopic dermatitis, which is the medical term for eczema. This means their eczema should be active and bothering them significantly, despite trying other treatments.

There might be other specific health conditions or medications that could prevent a child from joining, so it's important to discuss your child's complete medical history with the study team.

Quick self-check

Is my child between 2 and 11 years old?
Does my child have eczema (atopic dermatitis)?
Is my child's eczema considered moderate to severe?
Are we able to attend regular clinic visits for about a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child participates, they would receive the study medicine, Nemolizumab. The study is planned to last for a total of 52 weeks, which is about one year.

During this time, your child would have several visits to the study clinic. These visits would involve check-ups with doctors and nurses, blood tests to check the level of Nemolizumab in their body, and assessments of their eczema to see if it's improving. The doctors will also carefully monitor your child for any side effects at every visit throughout the year.

There will be specific times at 4, 8, 12, 16, 32, and 52 weeks where the blood levels of the medicine will be particularly checked. The aim is to understand how the medicine behaves in your child's system over time.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new medicine that could help improve your child's eczema symptoms, which might not be available otherwise. However, it's also important to be aware of potential risks. Like all medicines, Nemolizumab could have side effects, and some might be unknown at this stage. The study team will carefully monitor your child for any problems, but there's no guarantee the medicine will work for every child. You always have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (3)

—
Hungary
—
Spain
—
Poland

Common questions

What is eczema?

Eczema, or atopic dermatitis, is a common skin condition that causes dry, itchy, red, and sometimes cracked skin.

What is Nemolizumab?

Nemolizumab is an investigational medicine being studied for its potential to treat moderate to severe eczema in children.

How long will the study last for my child?

Your child's participation in the study, including follow-up, is expected to last for a total of 52 weeks, which is about one year.

Will my child definitely get the new medicine?

Yes, in this particular study, all participants will receive the investigational medicine, Nemolizumab.

What if we decide we want to stop participating?

You are free to withdraw your child from the study at any point, and it will not affect their regular medical care.