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A study to evaluate the effectiveness and safety of lebrikizumab in adults with nummular eczema who do not respond well to topical corticosteroids.

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 study focuses on Nummular Dermatitis, a skin condition that causes itchy, coin-shaped patches on the skin. The research aims to evaluate the efficacy and safety of lebrikizumab, which is an injectable medication, compared to a placebo. This study is intended for adults whose condition is not well-managed by topical corticosteroids, which are medicated creams or ointments applied directly to the skin.

Participants in the study will receive either lebrikizumab or a placebo via a subcutaneous injection, which is a method of delivering medication into the fatty layer just under the skin. The study includes a period where participants are monitored for 24 weeks, followed by an extension phase. During the trial, changes in pruritus, which is the medical term for itching, and the overall impact of the skin condition on daily life will be observed.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    You will receive either lebrikizumab, which is the study medication, or a placebo, which is an inactive substance that contains no medicine.

    The medication will be given as a subcutaneous injection, which means it is injected into the fatty layer of skin just under the skin.

    This process is part of a double-blind study, meaning neither you nor the researchers will know which substance is being administered.

    The effectiveness and safety of the lebrikizumab will be monitored for a period of up to 24 weeks.

  2. Step 2

    Monitoring and evaluation

    The study focuses on measuring the reduction of nummular eczema, a skin condition characterized by coin-shaped inflammatory patches.

    Changes in pruritus, which is the medical term for itching, will be recorded using a scale to see if the intensity of the itch decreases.

    The dermatology life quality index, a tool used to measure how skin problems affect daily life, will be assessed to track changes in well-being up to week 24.

Who can join the trial?

5 criteria

  • You must be an adult, which means you are 18 years of age or older at the time of the initial screening.
  • You must have been diagnosed with nummular eczema (a skin condition that causes itchy, coin-shaped patches) by a doctor.
  • You must have shown signs or symptoms (physical indicators or feelings of the condition) of nummular eczema for at least 6 months before the study begins.
  • You must be able to understand the purpose and risks of the study and be willing to follow all the rules and steps of the research plan.
  • You must be able to provide written informed consent, which is a formal document you sign to show you understand the study and agree to participate.

Who cannot join the trial?

7 criteria

  • Having a history or current presence of moderate-to-severe atopic dermatitis, which is a common type of skin inflammation, measured by an EASI score (an assessment tool used to measure the severity of skin disease) of 16 or higher.
  • Having any skin disease other than nummular eczema (a type of skin inflammation that causes coin-shaped spots) or mild atopic dermatitis that might make it difficult to measure the results of the study, such as psoriasis (a condition that causes red, itchy, and scaly patches) or other forms of eczema.
  • Having any skin signs that look like psoriasis, such as nail pitting (small dents in the fingernails or toenails), or having issues on the scalp, palms, soles of the feet, or skin folds, as well as having a personal or family history of psoriasis or psoriatic arthritis (a type of arthritis that affects people who have psoriasis).
  • A history of anaphylaxis, which is a severe and potentially life-threatening allergic reaction.
  • Being pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.
  • Having a known sensitivity or allergy to any of the ingredients used to make the study medication.
  • Being required to live in or be part of an institution due to an order from judicial (court-related) or administrative (government-related) authorities.
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Investigated drugs

Lebrikizumab is a medication given as a way to help treat eczema by targeting specific parts of the immune system that cause skin inflammation. It is administered through an injection under the skin.

What is already known about the treatment

  • Lebrikizumab

    This medication is an injectable solution that is administered through a small needle under the skin. It is a recently developed treatment currently being studied in late-stage clinical trials to help manage skin inflammation. The drug works by specifically blocking a protein in the body called interleukin-13, which plays a key role in causing redness, itching, and swelling. It is classified as a biologic therapy used primarily to treat inflammatory skin conditions like nummular eczema.

  • Placebo

    This is an inactive substance that looks exactly like the real medication but contains no active medicinal ingredients. It is administered using the same method as the test drug to ensure that neither the patients nor the doctors know which treatment is being received. In clinical studies, it is used as a standard tool to compare the effectiveness and safety of new medicines. It has no therapeutic effect and is used solely for scientific comparison.

Investigated diseases

Nummular Dermatitis - This condition is characterized by the appearance of coin-shaped patches on the skin. These patches can be dry, scaly, or even crusty. The skin in these areas may feel very itchy and inflamed. As the condition progresses, the spots may weep fluid or become thicker. The patches often appear on the arms or legs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522403-17-00Protocol codeM-27501-30Estimated enrolment290 patientsSponsorAlmirall S.A.

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