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

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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 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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Associatie dermatologie Maldegem	Maldegem	Belgium
University Of Luebeck	Luebeck	Germany
University Of Debrecen	Debrecen	Hungary
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Diejyyiri Kumw	Kaposvar	Hungary
Mkkvwqnwhmb Cazmvqc Fgr Mbevwlv Slusqfs &xaja Sjsbpsld Gybq	Magdeburg	Germany
Tzkinlhahii uhk Sugdueygbtw Bbxdbtwn Gwwm	Bad Bentheim	Germany
Aexlqpr Urydd Sgssjpgfn Ldmadz Ds Bamggwm	Bologna	Italy
Htmehxvq Dt Le Socgf Clvu I Sjfy Pfn	Barcelona	Spain
Hxepbtan Vrjo dxpjranm	Barcelona	Spain
Fewsocdylm Guyy	Offenbach Am Main	Germany
Cocoek Hdnqleekpr E Utqqjbsfvyflw Dr Csgyurl Euhpuy	Coimbra	Portugal

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
Portugal	Not recruiting	10.01.2025
Spain	Not recruiting	10.01.2025

Trial locations

Investigated drugs:

Dupilumab

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.

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 ID:

2024-514737-37-00

Protocol code:

EFC18365

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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