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A study to evaluate the safety and effectiveness of galvokimig in 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 study is designed to evaluate the safety and effectiveness of a new medication called galvokimig in adults living with atopic dermatitis, a condition often referred to as eczema that causes skin inflammation, itching, and redness. Participants in the study will be assigned to receive either galvokimig or a placebo, which is an inactive substance, through a subcutaneous injection. This method involves delivering the medication into the fatty layer of tissue just beneath the skin.

The study will monitor how different doses of the drug affect the skin and how the body processes the medication over a period of 16 weeks. During this time, the condition of the skin and the intensity of itching will be observed to determine how well the treatment works compared to the inactive substance.

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

    Participation in the study begins with the administration of either galvokimig or a placebo, which is a substance containing 0.9% sodium chloride solution that does not have an active medicinal effect.

    The medication is administered via subcutaneous use, which means it is injected into the fatty tissue just under the skin.

    The treatment period lasts for a total of 16 weeks.

  2. Step 2

    Monitoring and evaluation

    During the 16 weeks of treatment, the condition of the atopic dermatitis, also known as eczema, is monitored.

    The effectiveness of the medication is measured by tracking changes in skin severity using the eczema area and severity index (EASI) and the investigator global assessment (vIGA).

    The intensity of pruritus, which is the medical term for itching, is recorded using a weekly scale.

    Any adverse events, which are side effects or unexpected medical occurrences, are documented throughout the study duration.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older when you sign the agreement to join the study.
  • You must have had atopic dermatitis, which is a long-term skin condition often called eczema, for at least one year before starting the study.
  • Your skin condition must be rated as moderate to severe based on a doctor's assessment, specifically having a score of 3 or higher on the Investigator Global Assessment, which is a tool used by doctors to measure how much skin disease is present.
  • You must have an Eczema Area and Severity Index (EASI) score of 16 or higher, which is a specific measurement used to track the extent and seriousness of your eczema.
  • You must have a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 4 or higher, which is a scale used to measure the intensity of your itching.
  • The eczema must cover at least 10% of your total body surface area.
  • You must have a recent history, within the last 6 months, of not getting enough relief from topical medications, which are medicines applied directly to the skin like creams or ointments.
  • Alternatively, you may qualify if using skin creams or ointments is not recommended for you due to safety risks or side effects, and you are a candidate for systemic therapy, which refers to medicines that work throughout the entire body rather than just on the skin.

Who cannot join the trial?

9 criteria

  • You cannot participate if you have any medical or mental health conditions, or if your physical exam, blood tests, or electrocardiogram (a test that records the electrical activity of your heart) show results that might make taking the study medicine unsafe or make it difficult to measure the study results accurately.
  • You cannot participate if you have active skin conditions that could make it hard to tell if the study treatment is working, such as scabies (a skin infestation caused by tiny mites), seborrheic dermatitis (a common skin condition that causes flaky, red skin), cutaneous lymphoma (a type of cancer that starts in the skin), ichthyosis (a condition that causes dry, scaly skin), psoriasis (a condition that causes red, itchy, and scaly patches), or allergic or irritant contact dermatitis (skin inflammation caused by touching something that causes a reaction).
  • You cannot participate if you or your immediate family members (such as parents or siblings) have inflammatory bowel disease, which includes Crohn’s disease and ulcerative colitis (long-term diseases that cause inflammation in your digestive tract).
  • You cannot participate if you have had chronic or repeating infections, or a serious or life-threatening infection (such as herpes zoster, also known as shingles) within the 6 months before the start of the study.
  • You cannot participate if you meet the criteria for tuberculosis (a serious infection that usually affects the lungs).
  • You cannot participate if you have been treated with galvokimig before.
  • You cannot participate if you had safety issues while taking interleukin (IL)-13 biologic response modifiers (a type of medicine used to treat inflammation), such as dupilumab, tralokinumab, or lebrikizumab, that forced you to stop the medicine and change your treatment.
  • You must stop all systemic therapies (medicines that work throughout the whole body), topical therapies (medicines applied directly to the skin), and other treatments for your skin condition at least 4 weeks before the study begins.
  • You must stop all biologic agents (medicines made from living organisms) at least 3 months before the study begins.
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Investigated drugs

Galvokimig is an experimental medicine given as an injection under the skin. It is being studied to see if it is effective and safe for helping adults who have moderate to severe atopic dermatitis, a condition that causes skin inflammation and itching.

What is already known about the treatment

  • Galvokimig

    This medication is provided as a liquid solution that is injected just under the skin. It is currently an experimental treatment being studied in clinical trials to see how well it works for people with moderate to severe atopic dermatitis, also known as eczema. It belongs to a class of drugs designed to target specific parts of the immune system to reduce skin inflammation and itching. At a molecular level, it works by blocking certain signals in the body that cause the immune system to attack the skin, thereby calming the redness and irritation.

  • Sodium chloride solution

    This is a simple salt-water mixture administered via injection to act as a placebo for comparison in this study. It is a well-known substance used widely in medicine for various purposes but contains no active medicinal ingredients to treat skin conditions. In this trial, it is used to help researchers determine if the effects seen in patients are truly caused by the test drug or by other factors. Because it is chemically inactive for the condition being studied, it serves as a neutral control group.

Investigated diseases

Atopic Dermatitis - This is a chronic condition that affects the skin, often causing it to become red, itchy, and inflamed. It typically begins in childhood and can persist or recur throughout a person's life. The skin barrier becomes impaired, making it difficult to retain moisture and easier for irritants to enter. This leads to dry, sensitive skin that may develop patches of redness or bumps. Symptoms often flare up periodically due to various environmental or internal triggers. Over time, the skin may become thickened or scaly from repeated irritation and scratching.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522578-35-00Protocol codeATD002Estimated enrolment164 patientsSponsorUCB Biopharma

sourced from the EU Clinical Trials Register and site verification

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