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Study on the Effects of LEO 138559 for Adults with Moderate-to-Severe Atopic Dermatitis

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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 atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. The trial will evaluate a new treatment called LEO138559, which is a solution for injection. This treatment is a type of protein known as a humanised IgG1 monoclonal antibody that targets a specific part of the immune system involved in atopic dermatitis. The study will compare the effects of different doses of LEO138559 with a placebo to understand its safety and effectiveness in treating moderate-to-severe atopic dermatitis in adults.

The purpose of the study is to find out how well LEO138559 works and how safe it is for people with moderate-to-severe atopic dermatitis. Participants in the study will receive injections of either LEO138559 or a placebo. The study will last for 16 weeks, during which participants will be monitored to see how their skin condition changes over time. The main focus will be on the percentage change in the severity of the skin condition from the start of the study to the end of the 16 weeks.

Throughout the study, researchers will also keep track of any side effects that participants might experience. This information will help determine the safety of LEO138559 and its potential as a treatment option for atopic dermatitis. The study aims to provide valuable insights into managing this skin condition and improving the quality of life for those affected by it.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, diagnosis of atopic dermatitis (AD), and previous treatment history.

    The study is designed for adults aged 18 to 75 with moderate-to-severe AD, as defined by specific clinical criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of AD using scores like EASI and vIGA-AD.

    The extent of skin involvement and itch severity are also measured.

  3. Step 3

    Randomization and treatment allocation

    Participants are randomly assigned to receive either the investigational drug LEO138559 or a placebo.

    LEO138559 is a solution for injection administered subcutaneously, with a concentration of 150 mg/ml.

  4. Step 4

    Treatment administration

    The treatment involves subcutaneous injections of LEO138559 or placebo, following one of four different dosage regimens.

    The specific dosage and frequency are determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored regularly to assess the efficacy and safety of the treatment.

    The primary measure of efficacy is the percent change in the EASI score from baseline to Week 16.

  6. Step 6

    Safety assessment

    Safety is evaluated by recording the number of treatment-emergent adverse events (TEAEs) from baseline to Week 16.

    Regular follow-up visits are scheduled to ensure participant safety and to collect necessary data.

  7. Step 7

    Completion of the study

    The study is expected to conclude by March 31, 2025.

    Final assessments are conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

7 criteria

  • Must be between 18 and 75 years old at the time of the first visit.
  • Must have a diagnosis of Atopic Dermatitis (AD) according to specific criteria and have had AD for at least 1 year.
  • Must have tried treatment with Topical Corticosteroids (TCS) within the last 12 months, and either not responded well or been unable to use them due to side effects or safety concerns. Topical Corticosteroids are creams or ointments used to reduce inflammation and itching.
  • Must have an EASI score of 12 or higher at the first visit and 16 or higher at the start of the study. The EASI score measures the severity of eczema.
  • Must have a vIGA-AD score of 3 or higher at both the first visit and the start of the study. The vIGA-AD score is a way to assess the overall severity of AD.
  • Must have Body Surface Area (BSA) involvement of 10% or more at both the first visit and the start of the study. BSA refers to the percentage of the body affected by AD.
  • Must have an ADSD Worst Itch score of 4 or higher on average over a week at the start of the study. This score measures the intensity of itching.
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Investigated drugs

LEO 138559 is an investigational medication being studied for its potential to treat moderate-to-severe atopic dermatitis, a skin condition characterized by red, inflamed, and itchy skin. This medication is administered through an injection under the skin. The trial aims to determine how effective and safe LEO 138559 is when given in different dosage regimens to adults suffering from this condition.

What is already known about the treatment

LEO 138559 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, a chronic skin condition. The main therapeutic indication for LEO 138559 is atopic dermatitis. At the molecular level, it works by targeting specific pathways involved in the inflammatory process, helping to reduce symptoms like itching and redness. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500777-14-00Protocol codeLP0145-2240Estimated enrolment250 patientsSponsorLeo Pharma A/S

sourced from the EU Clinical Trials Register and site verification

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