Study on the Effectiveness of Dupilumab Injections for Itch Relief in Adults with Lichen Simplex Chronicus

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What is this study about?

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 determine how effective and safe Dupilumab is in reducing the itchiness associated with moderate-to-severe LSC in adults who have not found relief with topical treatments.

Participants in the study will receive either Dupilumab, which is administered as a solution for injection in a pre-filled syringe, or a matched placebo. The purpose of the study is to see if Dupilumab can significantly reduce the itchiness of LSC over a period of 24 weeks. The study will monitor changes in the severity of itching and its impact on sleep and quality of life. Additionally, the study will track any side effects or adverse reactions to the treatment.

The trial is designed to be a randomized, double-blind, placebo-controlled study, meaning neither the participants nor the researchers will know who is receiving Dupilumab or the placebo. This approach helps ensure the results are unbiased. The study will last for approximately 24 weeks, during which participants will be regularly assessed to measure the effectiveness of the treatment and any changes in their condition.

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 presence of moderate-to-severe LSC, as indicated by specific criteria such as the Investigator’s Global Assessment score and the Worst-Itch Numerical Rating Scale (WI-NRS).

2 baseline evaluation

A baseline evaluation is performed to establish initial measurements. This involves recording the average worst-itch score over a 7-day period prior to the first day of treatment.

Participants must have a history of LSC for at least 6 months and have previously tried topical treatments without adequate results.

3 randomization and treatment initiation

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

The treatment period lasts for 24 weeks, during which injections are given at specified intervals.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor progress. This includes evaluating changes in itch severity, sleep disturbance, and quality of life.

Participants are observed for any adverse reactions to the treatment, and the presence of anti-drug antibodies is checked.

5 final evaluation

At the end of the 24-week treatment period, a final evaluation is conducted. This involves measuring the improvement in itch severity and other related symptoms.

The primary goal is to determine the proportion of participants who experience a significant reduction in itch severity.

Who Can Join the Study?

Participants must be at least 18 years old or the legal age of consent in the area where the study is happening.
Participants should have moderate-to-severe Lichen Simplex Chronicus (LSC), which is a skin condition. This is determined by a score of 3 or more on a scale used by doctors to assess the severity of the condition. They must also have at least one of the following: one lesion in the anogenital area, two or more lesions with at least one being 3 cm or larger, or at least one very severe lesion.
Participants must have had LSC for at least 6 months before the study starts.
Participants need to have a high level of itchiness from LSC, with an average score of 7 or more on a scale from 0 to 10, based on their worst itchiness over the 7 days before the study starts. They need to have recorded at least 4 daily scores during this time.
Participants should have tried a 2-week treatment with strong topical corticosteroids (a type of medication applied to the skin) and possibly a topical calcineurin inhibitor (another type of skin medication) within the last 6 months, but it did not work well enough. If they have used other systemic treatments (not just antihistamines) for LSC in the past 6 months, they may also qualify if these treatments were not effective.
Participants must use appropriate contraceptive measures.

Who Cannot Join the Study?

Participants who have a different skin condition other than neurodermatitis that could interfere with the study.
Participants who have used certain medications that might affect the study results.
Participants who have a history of severe allergic reactions to any of the study medications.
Participants who are pregnant or breastfeeding.
Participants who have any other medical condition that the study doctors think might make it unsafe for them to participate.
Participants who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Sanatorium profesora Arenbergera	Prague	Czechia
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
University General Hospital Of Ioannina	Ioannina	Greece
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Eurofins bioskin GmbH	Hamburg	Germany
Anima	Alken	Belgium
University Of Pecs	Pecs	Hungary
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Fakultni Nemocnice Bulovka	Prague	Czechia
Associatie dermatologie Maldegem	Maldegem	Belgium
General Hospital Of Nea Ionia Konstantopouleio Patision	Nea Ionia	Greece
DermaMed Research Kft.	Oroshaza	Hungary
Kvwop aaeqzizje Fcehfdr swqfeq	Prague	Czechia
Gkwpyd Uxucymgack Fmhmqxwjn	Frankfurt	Germany
Fahctkixx Plbc Ls Iqkxgniyhvbyp Bilrqpszf Dek Haqfeopx Ukmurzywanttd Lx Pjs	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.01.2025
Czechia	Not recruiting	10.01.2025
Germany	Not recruiting	10.01.2025
Greece	Not recruiting	10.01.2025
Hungary	Not recruiting	10.01.2025
Italy	Not recruiting	10.01.2025
Spain	Not recruiting	10.01.2025

Trial locations

Investigated drugs:

Dupilumab

Dupilumab is a medication being studied for its ability to reduce itching in adults with Lichen Simplex Chronicus (LSC), a skin condition characterized by chronic itching and thickened skin. This trial aims to see if dupilumab can help people who have not found relief from other topical treatments.

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. The itching can be severe and may interfere with daily activities and sleep.

Trial ID:

2024-514762-39-00

Protocol code:

EFC18366

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Dupilumab Injections for Itch Relief in Adults with Lichen Simplex Chronicus

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