A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults
Lichen simplex chronicus, or neurodermatitis, is a long-term skin condition. Constant scratching causes patches of skin to become thick, rough, and fiercely itchy. This itch can be distressing and often disrupts sleep and everyday life. This Phase 3 trial is testing whether an injection called dupilumab can help relieve this severe itch. Dupilumab is designed to calm specific signals in the immune system that cause inflammation and trigger the urge to scratch. Participants will be placed into two groups by chance. One group will receive dupilumab and the other will receive a placebo (a dummy injection with no active medicine). Over 24 weeks, doctors will monitor how much each person's itch reduces, whether their sleep improves, and how their skin heals. The goal is to see if dupilumab is a safe and effective treatment for this challenging skin condition.
At a glance
What is this study about?
Living with lichen simplex chronicus (neurodermatitis) can be exhausting. The condition creates an intense 'itch-scratch cycle'. The more you scratch, the thicker and itchier the skin becomes. Over time, these raised, leathery patches can cause pain, emotional distress, and broken sleep. Standard treatments, such as steroid creams, do not always provide enough relief for everyone.
This study is testing a medicine called dupilumab to see if it can break this cycle. Dupilumab is a type of targeted treatment known as a biologic. It is already used in the NHS for other conditions like severe eczema and asthma. It works by blocking two key proteins in the body that cause inflammation and drive the intense urge to scratch.
Researchers want to find out if dupilumab can significantly reduce severe itching over 24 weeks of treatment. They will also measure improvements in sleep quality and day-to-day well-being. Because this is a Phase 3 study, it is one of the final stages of research required to show whether the medicine works well and is safe before it can be approved specifically for this condition.
Key takeaways
- The trial tests whether dupilumab can safely reduce severe itching from lichen simplex chronicus.
- It is open to adults aged 18 and over with persistent, itchy skin patches.
- Participants are randomly chosen to receive either dupilumab or a dummy injection (placebo).
- The main treatment period lasts for 24 weeks with regular clinic check-ups.
- Taking part is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with lichen simplex chronicus (neurodermatitis). To take part, you should have persistent, troublesome itching that has not settled with standard treatments and affects your daily life.
Both men and women can join. However, you will need to have some health checks first to make sure the trial is safe for you. People with certain serious medical conditions, active infections, or specific allergies may not be able to participate.
A trial doctor will go through your full medical history, review your current skin treatments, and explain all study criteria before you decide whether to join.
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 aged 18 or over?
- Have you been diagnosed with lichen simplex chronicus (neurodermatitis)?
- Do you have severe, daily itching that disturbs your routine or sleep?
- Are you willing to attend regular clinic appointments over at least 24 weeks?
- Are you comfortable receiving regular injections under the skin?
What does participation involve?
Taking part usually lasts around six months (24 weeks) of treatment, followed by a monitoring period. You will receive injections just under the skin at set times throughout the trial. Half of the participants will receive dupilumab, and the other half will receive a matched placebo (a dummy treatment). Neither you nor the study team will know which one you are receiving.
You will need to attend regular clinic visits. At these appointments, doctors will examine your skin, check your general health, and take blood and urine samples. You will also be asked to complete simple daily or weekly questionnaires to rate your itch levels, sleep quality, and how the condition affects your daily life.
Potential risks and benefits
Locations (7)
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedCzechia
Common questions
What is a placebo?
A placebo looks identical to the real medicine but contains no active ingredients. It helps doctors see whether any improvements or side effects are truly caused by the study drug.
How is the medicine given?
It is given as an injection just under the skin, usually in the thigh, tummy, or upper arm, using a small needle.
Do I have to pay to take part?
No. The trial medicine, tests, and doctor visits are free. Many trials also help cover reasonable travel expenses to and from the clinic.
Can I carry on using my regular creams?
The study doctor will give you clear instructions on which moisturisers you can keep using and whether any prescription creams need to be paused.
What happens if my itching becomes unbearable?
Your comfort and safety always come first. The study doctor can offer standard 'rescue' treatments if your symptoms become too difficult to manage.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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