RecruitingOBSERVATIONAL

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults

This study is designed to understand how effective a medication called nemolizumab (Nemluvio®) is for people aged 12 and over who have moderate to severe eczema (atopic dermatitis). It's a 'real-world' study, meaning it observes how the medicine works when prescribed by doctors as part of their regular care. Researchers will gather information from doctors' assessments and directly from patients about their symptoms and quality of life over approximately 12 months. A special part of the study in Germany and the UK will also ask some participants to track their itching, sleep, and pain daily for two weeks. This study helps doctors understand the benefits of nemolizumab in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Galderma R&D

Enrolment target

1,000

Start

14 Jul 2025

Estimated completion

30 Nov 2027

Atopic Dermatitis

What is this study about?

This study, called 'Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults,' is looking into a new medicine called nemolizumab, also known as Nemluvio®. It's for teenagers and adults who have eczema, specifically a type called atopic dermatitis, which is moderate to severe. The main goal is to see how well nemolizumab works in real doctors' offices and clinics, not in a highly controlled research environment. Doctors will assess how patients are doing, and patients will also share their experiences and how their symptoms are affecting them.

The study will follow participants for about 12 months. It's a 'non-interventional' study, which means the decision to start treatment with nemolizumab is made by your own doctor, as they would normally do, based on what's best for you and approved guidelines. The study simply collects information on how you're responding to the treatment in your usual medical care, without changing anything about how your doctor treats you.

There's also a special part of the study happening in Germany and the UK. Some participants in these areas will be asked to fill in short daily diaries for two weeks, tracking things like how itchy they are, how well they're sleeping, and if they're experiencing any pain. This will be done remotely, usually through a website or app, so you won't need extra clinic visits for this part. This information helps researchers get a very detailed picture of how nemolizumab affects daily life.

Key takeaways

This study observes real-life use of nemolizumab for moderate to severe eczema.
It involves teenagers and adults aged 12 and older.
Your doctor makes all treatment decisions; the study doesn't change your care.
No extra doctor visits or tests are required beyond your usual medical routine.
Data will be collected over approximately one year.
A small part in the UK asks for daily feedback on itching and sleep for two weeks.

Who may be eligible?

To join this study, you need to be at least 12 years old and have moderate to severe eczema (atopic dermatitis). Your doctor must have decided that nemolizumab (Nemluvio®) is the right treatment for you, following the approved guidelines for the medicine.

You cannot join if you have any medical reasons that prevent you from taking nemolizumab, according to the official medicine information. You also can't participate if you've taken part in another experimental drug study in the last three months, or if you've been treated with nemolizumab before this study.

Finally, it's important that you or your legal representative are able to understand the study information and give your permission to take part, and that you can comfortably fill out any questionnaires the study might ask you to complete.

Quick self-check

Are you at least 12 years old?
Do you have moderate to severe atopic dermatitis (eczema)?
Has your doctor decided to treat you with nemolizumab (Nemluvio®)?
Have you *not* tried nemolizumab before this plan?
Have you *not* been in another experimental drug study in the last 3 months?
Can you understand the study information and give your permission to take part?

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

What does participation involve?

If you decide to participate, you will receive nemolizumab (Nemluvio®) as prescribed by your doctor, just as you would if you weren't in the study. The study doesn't ask you to have extra visits, procedures, or lab tests beyond what your doctor already recommends for your routine care. The timing and number of your doctor's appointments will not be changed by the study; they will follow your usual medical practice.

The study will collect information over approximately 12 months. In the UK (and Germany), a sub-study involves some participants answering short daily questions about their itching, sleep, and pain for 14 days. This part is done remotely, so no extra clinic visits are needed. The study's main purpose is to observe and collect information from your standard medical care, rather than adding new requirements.

Potential risks and benefits

The potential benefits of participating mean you will receive a treatment that your doctor has already decided is suitable for your moderate to severe eczema, with the possibility of improving your symptoms. As this is an observational study, you won't undergo any extra procedures or visits beyond your usual medical care, which means there are no additional risks directly from the study itself. Any risks related to nemolizumab would be the same as if you were taking the medicine outside of the study, and your doctor will discuss these with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (108)

Galderma Investigational Site - 8893
Birmingham, United States· Active not recruiting
Galdrma Investigational Site - 7077
Phoenix, United States· Recruiting
Galderma Investigational Site 7060
Phoenix, United States· Recruiting
Galderma Investigational Site - 8535
Phoenix, United States· Recruiting
Galderma Investigational Site - 7067
Tucson, United States· Not yet recruiting
Galderma Investigational Site - 7074
Corona, United States· Not yet recruiting
Galderma Investigational Site 8636
Fountain Valley, United States· Not yet recruiting
Galderma Investigational Site 8224
Fremont, United States· Recruiting
Galderma Investigational Site 7099
Los Angeles, United States· Not yet recruiting
Galderma Investigational Site 8553
Newport Beach, United States· Recruiting
Galderma Investigational Site 7064
Santa Monica, United States· Not yet recruiting
Galderma Investigational Site 7107
Thousand Oaks, United States· Not yet recruiting

+96 more sites — see the official record for the full list.

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that causes dry, itchy, and irritated skin. It can sometimes be quite severe and affect daily life.

What is nemolizumab?

Nemolizumab (Nemluvio®) is a medication used to treat moderate to severe atopic dermatitis. Your doctor will have decided it's appropriate for you.

Will I have to take different medication if I join the study?

No, your doctor will prescribe nemolizumab as part of your usual care. The study doesn't change your treatment plan.

How long will I be in the study?

The study will observe your progress for about 12 months while you are receiving your regular care.

Do I need extra doctor's appointments for the study?

No, the study will use information from your regular doctor's appointments. There are no additional visits, except for a possible quick daily online diary in the UK part of the study.

How to find out more

Galderma Research and Development

clinical.studies@galderma.com 817-961-5000 Official trial record

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