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Study on Dupilumab for Itch Relief in Adults with Lichen Simplex Chronicus (Neurodermatitis)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called dupilumab on a skin condition known as Lichen Simplex Chronicus (LSC), which is also referred to as Neurodermatitis. LSC is a condition characterized by chronic itching and thickened skin. The study aims to see if dupilumab can help reduce the itching associated with this condition in adults who have not found relief from other topical treatments.

Participants in the study will receive injections of either dupilumab or a placebo. The study is designed to compare the effects of dupilumab with those of the placebo over a period of 24 weeks. During this time, participants will be monitored to see if there is an improvement in their symptoms, particularly the reduction of itching. The study will also look at how the treatment affects sleep disturbances caused by itching and overall quality of life.

The purpose of this study is to demonstrate the effectiveness of dupilumab in treating moderate-to-severe LSC in adults who have not responded well to other treatments. Participants will be assessed regularly to track changes in their symptoms and any side effects they may experience. The study will help determine if dupilumab can be a beneficial treatment option for those suffering from this persistent skin condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and the severity of the condition known as Lichen Simplex Chronicus (LSC).

    Eligibility is determined by the Investigator's Global Assessment (IGA) score, which must be 3 or higher, and the presence of specific lesions.

  2. Step 2

    Baseline measurement

    Participants are required to record their itch severity using the Worst-Itch Numerical Rating Scale (WI-NRS) for 7 days prior to the start of the treatment. This scale ranges from 0 to 10, and an average score of 7 or higher is necessary to proceed.

  3. Step 3

    Randomization and treatment initiation

    Participants are randomly assigned to receive either the test product, dupilumab, or a placebo. Dupilumab is administered as a solution for injection using a pre-filled syringe.

    The medication is given through subcutaneous injection, which means it is injected under the skin.

  4. Step 4

    Treatment duration

    The treatment period lasts for 24 weeks. During this time, participants continue to receive regular injections of the assigned product.

    Participants are monitored for any changes in their condition and any side effects that may occur.

  5. Step 5

    Primary evaluation

    The primary goal is to assess the improvement in itch severity, measured by a reduction of 4 or more points on the WI-NRS from baseline to Week 24.

  6. Step 6

    Secondary evaluations

    Secondary evaluations include changes in sleep disturbance due to itching, quality of life scores, and the incidence of any adverse effects related to the treatment.

    These evaluations are conducted at various points throughout the study, including at Week 12 and Week 24.

  7. Step 7

    Completion and follow-up

    Upon completion of the 24-week treatment period, participants undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

    Participants may be asked to attend follow-up visits to monitor any long-term effects of the treatment.

Who can join the trial?

6 criteria

  • Participant must be at least 18 years old or the legal age of consent in the area where the study is happening at the time of signing the informed consent.
  • Participants should have moderate-to-severe **LSC** (Lichen Simplex Chronicus), which is a skin condition, as determined by a doctor's assessment. This includes having at least one of the following: at least one single lesion in the anogenital area; at least two lesions, with one being 3 cm or larger; or at least one severe lesion.
  • Participants must have had **LSC** for at least 6 months before the screening visit.
  • On a scale from 0 to 10, participants must have an average worst-itch score of **7 or higher** for **LSC** in the 7 days before the first day of the study. At least 4 daily scores out of these 7 days are needed to calculate the average. If not enough scores are reported, the start of the study can be delayed, but not beyond 28 days from the screening period.
  • Participants must have a history of not responding well to a 2-week treatment with medium-to-strong topical corticosteroids (a type of medication applied to the skin) with or without topical calcineurin inhibitors (another type of skin medication) for **LSC** in the last 6 months, unless these treatments are not medically advisable. Participants who have used other systemic treatments (not just antihistamines) for **LSC** in the past 6 months may also be eligible after stopping those treatments for a certain period.
  • Participants must use appropriate contraceptive measures.

Who cannot join the trial?

5 criteria

  • Participants who have a different skin condition other than neurodermatitis cannot join. Neurodermatitis is a skin condition that causes itching and thickened skin.
  • Participants who are not adults cannot join. This means only people who are 18 years or older can participate.
  • Participants who have their skin condition well-controlled by creams or ointments cannot join. The study is for those whose condition is not well-managed by these treatments.
  • Participants who are not experiencing moderate-to-severe symptoms cannot join. This means the study is for those with more serious symptoms.
  • Participants who are not experiencing itching related to LSC cannot join. LSC stands for Lichen Simplex Chronicus, which is a skin condition that causes thick, itchy patches of skin.
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Investigated drugs

Dupilumab is a medication used in this clinical trial to treat itching associated with Lichen Simplex Chronicus (LSC) in adults. LSC is a skin condition characterized by chronic itching and thickened skin. Dupilumab works by blocking certain proteins in the body that can cause inflammation and itching. This trial aims to see how effective and safe dupilumab is for people with moderate-to-severe LSC who have not had enough relief from creams or ointments applied to the skin.

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating pruritus associated with Lichen Simplex Chronicus (LSC), a condition related to neurodermatitis. The main therapeutic indication for dupilumab in this context is to alleviate itching in adults with moderate-to-severe LSC that is not adequately managed by topical treatments. At the molecular level, dupilumab works by blocking certain proteins involved in the inflammatory response, which helps reduce symptoms like itching and skin inflammation. It is classified as a monoclonal antibody, which is a type of medication designed to target specific pathways in the immune system.

Investigated diseases

Neurodermatitis – Neurodermatitis, also known as lichen simplex chronicus, is a skin condition characterized by chronic itching and scratching. It often begins with a patch of itchy skin, which becomes more irritated the more it is scratched. This leads to a cycle of itching and scratching that can cause the affected skin to become thickened and leathery. The condition can occur anywhere on the body but is most commonly found on the neck, wrists, forearms, legs, or anal region. The exact cause of neurodermatitis is not well understood, but it may be related to stress, anxiety, or other skin conditions like eczema. It is not contagious and typically affects adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514737-37-00Protocol codeEFC18365Estimated enrolment196 patientsSponsorSanofi-Aventis Recherche & Developpement

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).