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Study on the Effectiveness and Safety of Deucravacitinib for Adults with Chronic Hand Eczema

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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 Chronic Hand Eczema, a condition where the skin on the hands becomes red, itchy, and inflamed over a long period. The study will test the effectiveness and safety of a medication called Deucravacitinib, which is taken as a 6 mg film-coated tablet. Participants in the study will either receive this medication or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how well Deucravacitinib works in treating adults with chronic hand eczema. Participants will take the medication or placebo daily for up to 16 weeks. Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms. The study will also assess the impact of the treatment on participants' quality of life and the severity of their eczema.

During the study, various assessments will be conducted, including self-assessments by participants and evaluations by healthcare professionals. These assessments will help determine the effectiveness of the treatment in reducing the symptoms of chronic hand eczema. The study will also monitor the safety of the medication by checking for any side effects and changes in skin health. The trial aims to provide valuable information on the potential benefits of Deucravacitinib for individuals suffering from this persistent skin condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Visit and Baseline Assessment
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a diagnosis of chronic hand eczema that has persisted for more than 3 months or returned twice or more within the past 12 months.
A baseline assessment is performed, which includes an Investigator Global Assessment (IGA) score of 3 or higher on a scale of 0 to 4, indicating moderate to severe disease.
Participants must have failed topical therapy for 6 weeks and be eligible for systemic therapy.
Step 2
Medication Administration
Participants are randomly assigned to receive either deucravacitinib or a placebo. The medication is administered orally in the form of 6 mg film-coated tablets.
The dosage is 6 mg taken twice daily (BID), which means once in the morning and once in the evening.
Step 3
Follow-Up Visits and Assessments
Regular follow-up visits are scheduled to monitor progress and assess the treatment's efficacy and safety.
Assessments include Participant Self-Assessment (PSA) at baseline, week 2, 4, 6, 8, 12, and 16.
The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is completed at baseline, week 4, 8, and 16.
The Hand Eczema Severity Index (HECSI) is evaluated at baseline, week 4, 8, and 16.
Step 4
Final Evaluation
At week 16, a final evaluation is conducted to determine the therapeutic efficacy of deucravacitinib.
The primary endpoint is the percentage of patients achieving a clinical response with an IGA score of 0 or 1 and a 2-point improvement from baseline.
Secondary endpoints include changes in skin physiology, histology, expression of skin barrier proteins, cytokines, immune cells in skin biopsies, and the transcriptome.

Who can join the trial?

8 criteria

Patients must have signed and dated a written informed consent form approved by the appropriate authorities before any study-related procedures begin.
Patients must have a diagnosis of chronic hand eczema, which means the condition has lasted for more than 3 months or has returned two or more times in the past 12 months.
Patients must have moderate to severe disease, with an Investigator Global Assessment (IGA) score of 3 or higher on a scale from 0 to 4, at both the screening and baseline visits. The IGA score is a way to measure the severity of the condition.
Patients who have not improved with topical therapy (creams or ointments applied to the skin) for 6 weeks and are eligible for a treatment that affects the whole body (systemic therapy) can participate.
Patients must be male or female and between 18 to 65 years old.
Patients must have a body mass index (BMI) between approximately 18 and 35 kg/m². BMI is a measure of body fat based on height and weight.
Patients must be able to provide written informed consent, meaning they understand and agree to participate in the study.
Patients must be willing and able to attend clinic visits and follow study-related procedures.

Who cannot join the trial?

7 criteria

Patients who are under 18 years old cannot participate.
Patients who are pregnant or breastfeeding are not allowed to join the study.
Patients with other skin conditions that might interfere with the study results are excluded.
Patients who have used certain medications that could affect the study results are not eligible.
Patients with a history of severe allergic reactions to similar treatments cannot participate.
Patients with serious health conditions that might make it unsafe to participate are excluded.
Patients who are currently participating in another clinical trial are not allowed to join.

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Verified sites

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Charite Research Organisation GmbH
Berlin, Germany
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Technische Universitaet Dresden
Dresden, Germany

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Investigated drugs

Deucravacitinib is a medication being studied for its effectiveness in treating chronic hand eczema. It is taken daily and is being compared to a placebo to see how well it works in reducing the symptoms of this skin condition. The study aims to determine if this medication can help improve the condition of the skin on the hands of patients who have been dealing with eczema for a long time.

Deucravacitinib

What is already known about the treatment

Deucravacitinib – This medication is administered orally in the form of tablets, taken twice daily. It is currently being studied in clinical trials to assess its effectiveness and safety for treating chronic hand eczema. The main therapeutic indication is to alleviate symptoms associated with this skin condition. Deucravacitinib works by selectively inhibiting a specific enzyme involved in the inflammatory process, thereby reducing inflammation and improving skin condition. It is classified as a selective tyrosine kinase 2 (TYK2) inhibitor.

Investigated diseases

Chronic Hand Eczema – Chronic hand eczema is a persistent skin condition that primarily affects the hands, causing inflammation, redness, and itching. It often results in dry, cracked, and sometimes painful skin, which can interfere with daily activities. The condition may be triggered or worsened by exposure to irritants or allergens, such as chemicals, frequent hand washing, or certain materials. Over time, the skin may thicken and develop fissures, making it more susceptible to infections. The severity of symptoms can vary, with periods of flare-ups and remission. Managing the condition often involves identifying and avoiding triggers to prevent exacerbation.