Study on the Effectiveness of Deucravacitinib for Patients with Lichen Planus

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Deucravacitinib on patients with a skin condition known as Lichen Planus. Lichen Planus is a disease that causes swelling and irritation in the skin, hair, nails, and mucous membranes. The trial aims to evaluate how effective Deucravacitinib is in reducing the symptoms and activity of this disease. Deucravacitinib is a type of medication that works by selectively inhibiting a protein involved in the immune response, which may help in reducing inflammation and other symptoms associated with Lichen Planus.

Participants in the study will receive either Deucravacitinib or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will take place over several months, during which participants will have regular visits to monitor their condition and any changes in their symptoms. The goal is to see if Deucravacitinib can improve the clinical symptoms of Lichen Planus compared to the placebo.

The trial will involve multiple visits to assess the progress and any changes in the condition of the participants. These visits will help researchers understand the impact of Deucravacitinib on the disease and gather important data on its effectiveness and safety. The study is expected to provide valuable insights into the potential benefits of this medication for people suffering from Lichen Planus.

1 initial visit and baseline assessment

The trial begins with an initial visit, referred to as V1, on day 1. During this visit, a baseline assessment is conducted to evaluate the current state of the condition known as lichen planus.

The Lichen Planus Activity and Damage Index (LiPADI) Activity Score is used to measure the severity of symptoms. This score will be compared to future assessments to determine changes over time.

2 medication administration

Participants are randomly assigned to receive either the active medication, deucravacitinib, or a placebo. The medication is administered orally in the form of a film-coated tablet.

The dosage for deucravacitinib is 6 mg, taken once daily. The duration of this phase is until the end of the study, which is scheduled for day 112.

3 follow-up visits and assessments

Throughout the trial, several follow-up visits are scheduled to monitor progress and assess the effectiveness of the treatment. These visits are referred to as V3, V4, and other specified visits.

During these visits, the LiPADI Activity Score is reassessed, and additional evaluations may include changes in gene expression profiles and quality of life measures.

4 end of study assessment

The final visit, known as EOS (end of study), occurs on day 112. At this point, a comprehensive assessment is conducted to evaluate changes in symptoms and overall condition.

The primary focus is on the change in the LiPADI Activity Score from the baseline to the end of the study. Secondary assessments may include changes in gene expression and other health indicators.

Who Can Join the Study?

Participants can be either male or female and must be 18 years or older.
Participants must provide written informed consent, which means they agree to join the study after being informed about it.
Participants must have lichen planus, confirmed by a medical test called a histological test, and they must have symptoms.
Participants must be able to follow study instructions and be willing to attend and complete all required visits.
Participants must have a LiPADI Activity Score of 6 or higher, or 3 or higher if they have symptoms only in the mouth or other mucosal areas. The LiPADI Activity Score is a way to measure the severity of the condition.

Who Cannot Join the Study?

Patients with conditions other than lichen planus cannot participate. Lichen planus is a condition that causes swelling and irritation in the skin, hair, nails, and mucous membranes.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants must not belong to any vulnerable populations, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country	Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.11.2023

Trial locations

Investigated drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its effectiveness in treating patients with lichen planus. It works by selectively inhibiting TYK2, an enzyme involved in the immune response. This action may help reduce the symptoms and disease activity associated with lichen planus, a condition that causes inflammation and lesions on the skin and mucous membranes.

Investigated diseases:

Lichen Planus – Lichen planus is a chronic inflammatory condition that affects the skin and mucous membranes. It is characterized by purplish, itchy, flat-topped bumps that can appear on the wrists, lower back, and ankles, as well as in the mouth and other areas. The exact cause of lichen planus is not well understood, but it is believed to involve an immune system response. The disease can progress with periods of flare-ups and remissions, where symptoms may worsen or improve over time. In some cases, lichen planus can lead to the development of painful sores or lesions, particularly in the mouth. The condition is not contagious and varies in severity among individuals.

Trial ID:

2022-502991-21-00

Protocol code:

DER-202201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Deucravacitinib for Patients with Lichen Planus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?