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RecruitingTherapeutic confirmatory (Phase III)Interventional

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

Atopic dermatitis, commonly known as eczema, causes dry, red, and intensely itchy skin. For many adults, standard creams do not provide enough relief. This clinical trial is testing an experimental medicine called nemolizumab to treat moderate-to-severe eczema over a longer timeframe. The main aim of the study is to check the safety of nemolizumab and record any side effects that occur during treatment. Doctors will also track how effectively the medicine improves skin redness and swelling, relieves chronic itching, and helps patients sleep better. Taking part gives researchers vital information about how well this treatment works in daily life and whether it can improve overall wellbeing, mood, and day-to-day activities. The study involves regular health checks and reviews with a specialist doctor over several years.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Galderma S.A.
Enrolment target
1,164
Start
28 Aug 2024

What is this study about?

Atopic dermatitis is the most common form of eczema. It makes the skin dry, cracked, sore, and intensely itchy. For people with moderate or severe eczema, the condition can be exhausting. Constant scratching can damage the skin and disrupt sleep, while visible flare-ups can affect confidence, work, and mental health. While moisturising creams and steroid ointments help many people, they do not always keep severe symptoms under control.

This clinical trial is evaluating a newer medicine named nemolizumab. It works by targeting specific signals in the body's immune system that trigger inflammation and itching. By calming these signals, researchers hope the drug can give the skin time to heal and provide long-lasting relief from the urge to scratch.

Because eczema is a long-term condition, it is vital to know that treatments remain safe and helpful over many months or years. This study follows participants over an extended period (up to around four years) to closely monitor their health, watch for any unwanted side effects, and see if the improvements in their skin and quality of life last.

Key takeaways

  • Tests the long-term safety and benefit of nemolizumab for moderate-to-severe eczema.
  • Open to adults aged 18 and older with ongoing eczema symptoms.
  • Monitors improvements in skin clearing, itch relief, sleep, and overall quality of life.
  • Involves regular clinic visits and health assessments over up to four years.
  • Taking part is voluntary, and you can withdraw at any point.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with moderate-to-severe atopic dermatitis. It is aimed at people whose eczema covers a noticeable amount of skin or causes persistent, troublesome symptoms that have not fully cleared up with standard treatments.

Both men and women may be able to join. Because this is a long-term safety study, doctors will review each person's general health, medical background, and any other medications they are currently taking.

People with certain other skin conditions, serious active infections, or medical illnesses that could make taking part unsafe may not be able to join. The study team will carry out a detailed health check before anyone is enrolled to confirm whether the trial is suitable for them.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with atopic dermatitis (eczema).
  3. My eczema is considered moderate or severe.
  4. My symptoms are not fully controlled by standard creams or treatments.
  5. I am able to attend regular clinic appointments over a long period.
Answer every question to see your result.

What does participation involve?

Taking part in this study involves receiving the study medicine, nemolizumab, and attending regular appointments at a hospital or specialist clinic. The study is designed to run for a long period, with follow-up visits planned for up to roughly 200 weeks (around four years).

During clinic visits, the medical team will examine your skin to see how much eczema is present and whether it is clearing up. You will also have standard health checks, which may include checking your blood pressure, taking blood or urine samples, and discussing any symptoms you notice.

You will be asked to fill in brief questionnaires about your symptoms. These include rating how itchy your skin feels, how well you are sleeping, and whether eczema is affecting your daily work, mood, or everyday life. You will be supported by a dedicated research team throughout the entire process.

Potential risks and benefits

Taking part may help improve your eczema symptoms, reducing skin redness and giving you relief from severe itching, though improvements cannot be guaranteed. You will also receive close, regular health monitoring from skin specialists. However, like all medicines, nemolizumab can cause side effects. These can range from mild issues, such as skin irritation where an injection is given, to less common, more serious reactions. You can choose to leave the study at any point without giving a reason, and your regular NHS medical care will not be affected.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
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    Unverified
    Netherlands
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    Unverified
    Spain
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    Unverified
    France
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    Unverified
    Italy
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    Unverified
    Germany
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    Unverified
    Bulgaria
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    Unverified
    Latvia
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    Unverified
    Czechia
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    Unverified
    Estonia
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    Unverified
    Lithuania
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    Unverified
    Hungary
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    Unverified
    Belgium

Common questions

What is nemolizumab?

Nemolizumab is an experimental medicine designed to block specific proteins in the body that cause eczema-related swelling and itching.

How long will I be in the study?

This is a long-term study with visits scheduled for up to 200 weeks, which is roughly four years.

Will I have to pay for the study treatment?

No. The study medication, tests, and doctor visits related to the trial are provided free of charge.

Can I carry on using my normal eczema creams?

The study doctor will give you clear instructions on which moisturisers or skin treatments you can safely continue using during the trial.

Can I leave the trial if I change my mind?

Yes. Participation is completely voluntary, and you are free to withdraw at any time without it affecting your future care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Prospective, Multicenter, Long-Term Study to Assess the Sa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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