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Study on Tralokinumab for Moderate-to-Severe Atopic Hand Eczema in Patients Needing Systemic Therapy

Fast replyRegistered drugNo 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 Tralokinumab on a skin condition known as atopic hand eczema, which is a type of atopic dermatitis. Atopic hand eczema is a condition that causes the skin on the hands to become red, itchy, and inflamed. The study aims to evaluate how effective and safe Tralokinumab is when used as a treatment for people with moderate-to-severe atopic hand eczema who are candidates for systemic therapy, meaning they may need treatment that affects the entire body rather than just the skin.

Participants in the study will receive either Tralokinumab or a placebo, which is a substance with no active medication. The treatment involves receiving an injection of Tralokinumab every two weeks. The study will last for a period of 40 weeks, during which the participants' skin condition will be monitored to see if there is an improvement in the severity and extent of their eczema. The goal is to determine if Tralokinumab can help clear or significantly reduce the symptoms of atopic hand eczema compared to the placebo.

Throughout the study, participants will be regularly assessed to track changes in their skin condition. The main focus will be on achieving a clear or almost clear skin condition by the 16th week of treatment. Additionally, the study will look at other improvements, such as a reduction in the severity of eczema symptoms. This research is important for understanding how well Tralokinumab works for treating atopic hand eczema and ensuring its safety for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have already provided informed consent and met the necessary inclusion criteria, such as being 18 years or older and having a history of atopic dermatitis for at least 12 months.

    The patient must have moderate-to-severe atopic hand eczema that has persisted for more than 3 months or returned multiple times within the last year.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm the severity of the condition, which must be moderate-to-severe according to specific criteria.

    The assessment will include a review of the patient's medical history and current symptoms.

  3. Step 3

    Treatment phase

    The patient will receive tralokinumab 300 mg or a placebo every two weeks. The medication is administered through a subcutaneous injection.

    This phase will last for 16 weeks, during which the patient will continue to receive the injections at the specified intervals.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment phase, the patient's condition will be monitored regularly to evaluate the effectiveness of the treatment.

    The primary goal is to achieve a score of 0 (clear) or 1 (almost clear) on a specific scale by Week 16.

  5. Step 5

    Completion of treatment

    At the end of the 16-week treatment period, the patient's progress will be assessed to determine the overall effectiveness of the treatment.

    Secondary outcomes include achieving significant reductions in specific eczema severity scores.

Who can join the trial?

12 criteria

  • You must sign and date a form that shows you understand the study and agree to participate.
  • You need to be at least 18 years old.
  • You should be willing to follow the rules and guidelines of the study.
  • You must have a diagnosis of atopic dermatitis, which is a type of skin condition, according to specific criteria.
  • You should have had atopic dermatitis for at least 12 months before joining the study.
  • You need to have atopic hand eczema that has lasted for more than 3 months or has come back at least twice in the last year, while avoiding things that irritate your skin.
  • Your skin condition should be considered moderate to severe at the start of the study.
  • You must have atopic dermatitis affecting at least one other part of your body besides your hands and wrists.
  • You need to follow a routine of using non-medicated skin care and avoid things that can irritate your skin throughout the study.
  • You should have a certain level of itchiness, measured by a score of 4 or higher, based on your itchiness over a week before starting the study.
  • You must have tried prescription creams or ointments for your hand eczema in the past year, but they didn't work well enough, or you couldn't use them due to side effects or safety concerns.
  • If you are a woman who can have children, you must use a very effective form of birth control during the study and for at least 16 weeks after the last treatment. This includes methods like certain birth control pills, devices, or procedures that are very reliable.

Who cannot join the trial?

3 criteria

  • Patients who do not have moderate-to-severe atopic hand eczema cannot participate. This means the skin condition on the hands must be of a certain severity.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.
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Investigated drugs

Tralokinumab is a medication being studied for its effectiveness in treating moderate-to-severe atopic hand eczema. It is used as a monotherapy, which means it is given alone without any other medications. The goal of using tralokinumab in this trial is to see how well it can reduce the severity and spread of eczema on the hands. This medication is administered every two weeks to participants who are candidates for systemic therapy, meaning they need treatment that affects the entire body rather than just the skin.

What is already known about the treatment

Tralokinumab – Tralokinumab is administered as an injection under the skin, typically every two weeks. It is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic hand eczema, a condition characterized by inflamed, itchy skin. The medication works by targeting and inhibiting a specific protein in the immune system called interleukin-13 (IL-13), which plays a role in the inflammatory process associated with eczema. Tralokinumab is classified as a monoclonal antibody, a type of medication designed to specifically target and neutralize certain proteins in the body.

Investigated diseases

  • Atopic Dermatitis

    Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. Flare-ups can occur periodically, often triggered by environmental factors or stress. The condition is associated with a malfunction in the skin barrier and immune system, leading to increased sensitivity to irritants and allergens. It is commonly found in individuals with a family history of allergies or asthma.

  • Atopic Hand Eczema

    Atopic hand eczema is a form of eczema that specifically affects the hands, causing them to become dry, itchy, and inflamed. It is often seen in individuals with a history of atopic dermatitis or other allergic conditions. The skin on the hands may crack, blister, or peel, leading to discomfort and difficulty in performing daily tasks. This condition can be exacerbated by frequent hand washing, exposure to irritants, or changes in weather. It tends to be persistent and may require ongoing management to control symptoms. The condition can significantly impact the quality of life due to its visibility and the functional importance of the hands.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502653-34-01Protocol codeLP0162-2328Estimated enrolment402 patientsSponsorLEO PHARMA A/S

sourced from the EU Clinical Trials Register and site verification

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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).