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 (neurodermatitis) causes patches of skin to become intensely itchy. Constant scratching makes the skin thick, rough, and sore, which can disrupt sleep and affect everyday life. This clinical study is looking at whether an injection called dupilumab can break this itch-scratch cycle. Dupilumab is already used for other skin conditions like eczema. In this phase 3 trial, researchers want to find out if it is safe and effective for adults with neurodermatitis. Participants will receive either dupilumab or an identical dummy injection (placebo) for 24 weeks. Neither the doctors nor the participants will know who receives which treatment until the study ends. Researchers will measure how much the itch improves, how well people sleep, and whether their skin clears up.
At a glance
What is this study about?
Lichen simplex chronicus, often called neurodermatitis, starts with an itch that triggers an urge to scratch. Scratching irritates the skin further, leading to more itching. Over time, the skin thickens, turns leathery, and becomes deeply uncomfortable. For many people, this constant itching is hard to control and can cause broken sleep, stress, and frustration.
This clinical trial is testing a medicine called dupilumab to see if it can relieve this severe itching and help the skin heal. Dupilumab works by calming down specific signals in the immune system that cause skin inflammation and itchiness. It is already approved in the UK for several other conditions, but doctors need clear proof to show whether it works well for lichen simplex chronicus.
Because this is a phase 3 study, it compares dupilumab directly to a placebo (a dummy treatment with no active drug). Using a placebo helps researchers know for sure whether any improvements are truly caused by the medicine. If successful, this study could lead to a new treatment option for people living with persistent, hard-to-treat neurodermatitis.
Key takeaways
- The trial tests whether dupilumab relieves severe itching caused by neurodermatitis (lichen simplex chronicus).
- It is open to adults aged 18 and older with active, itchy skin patches.
- Participants will receive either the study drug or a dummy injection (placebo) for 24 weeks.
- Doctors will measure changes in daily itching, sleep quality, and skin appearance.
- Participation is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with lichen simplex chronicus (neurodermatitis). You must have active, itchy patches of skin that bother you on a daily basis.
To take part, you should be willing to attend regular hospital appointments, receive injections under the skin, and fill out daily diaries about your itching and sleep. Both men and women can join.
People with certain other skin conditions, serious medical problems, or active infections may not be able to participate. The study team will review your full medical history and perform a health check before you can join to ensure it is safe for you.
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.
- I am aged 18 or older.
- I have been diagnosed with lichen simplex chronicus (neurodermatitis).
- I experience ongoing, bothersome itchiness from my skin patches.
- I am willing to receive injections under the skin.
- I can attend regular clinic visits and keep a daily diary of my symptoms.
What does participation involve?
Taking part lasts for around six to seven months. During this time, you will visit the hospital clinic regularly for health checks, skin assessments, and blood tests. The trial medicine (either dupilumab or a matching placebo) is given as an injection under the skin every few weeks. You will also be asked to keep a simple daily diary to track your itch levels and how well you sleep. The study doctor will monitor your skin closely throughout the trial to see if your patches are clearing and to check for any side effects.
Potential risks and benefits
Locations (8)
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedPortugal
Common questions
What is dupilumab?
Dupilumab is a biological medicine that targets specific proteins in the immune system to reduce inflammation and itching. It is already approved for conditions such as eczema and asthma.
Will I definitely get the active medicine?
No. This is a randomised study, meaning a computer randomly assigns you to receive either dupilumab or a dummy treatment (placebo). Neither you nor your study doctor will choose which one you receive.
How is the medicine given?
The medicine is given as a small injection just under the skin, usually in the tummy or thigh, using a fine needle.
Does taking part cost anything?
No. The study medication, clinic visits, and tests are provided free of charge. Travel expenses to and from the clinic are usually reimbursed.
Can I leave the study if I change my mind?
Yes. You can leave the study at any point without giving a reason. Your standard medical care will continue as normal.
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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