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Study of GHZ339 for treatment of 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 focuses on patients with moderate to severe atopic dermatitis, a chronic inflammatory skin condition that causes itchy, red, and inflamed skin. The main investigational treatment being tested is GHZ339, which will be given as an injection under the skin. The study will also evaluate various topical treatments including tacrolimus, pimecrolimus, and different strengths of corticosteroids. Some participants will receive placebo instead of the active treatment.

The purpose of this research is to understand how different doses of GHZ339 work compared to placebo in treating atopic dermatitis, specifically looking at how much the skin condition improves after 16 weeks of treatment. The study is designed as a platform trial, which means it will test multiple treatments simultaneously.

During the study, participants will receive either GHZ339 injections or placebo injections, along with various topical medications that are applied directly to the skin. The treatment period will last for several months, during which participants will have regular check-ups to monitor their skin condition and overall health. The effectiveness of the treatment will be measured by examining changes in the severity and extent of skin inflammation.

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

    Initial qualification

    Your medical history will be reviewed to confirm you have had atopic dermatitis for at least 1 year

    Your condition must be classified as moderate to severe

    Previous treatment with topical medications must have been inadequate or unsuitable for you

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either the study medication or placebo

    The study medication may include GHZ339 (given by injection under the skin), tacrolimus (applied to skin), or pimecrolimus (applied to skin)

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Treatment period

    The treatment will continue for 16 weeks

    You will need to apply the medication to your skin or receive injections as instructed

    Regular assessments of your skin condition will be conducted using the EASI score (a measure of eczema severity)

    Your overall skin condition will be evaluated using the IGA score (Investigator's Global Assessment)

  4. Step 4

    Monitoring

    Throughout the study, you will have regular check-ups that include:

    Vital signs measurements

    Heart recordings (ECG)

    Laboratory blood tests

    Assessment of any side effects

  5. Step 5

    Final evaluation

    At week 16, final assessments will be conducted to measure:

    The percentage change in your EASI score from the beginning of the study

    Whether your skin has cleared or almost cleared (IGA score)

    Whether your EASI score has improved by 75% or more

Who can join the trial?

7 criteria

  • Must be able and willing to provide written informed consent to participate in the study
  • Must have been diagnosed with atopic dermatitis (a chronic inflammatory skin condition causing itchy, red, swollen and cracked skin) for at least 1 year
  • Must have moderate to severe atopic dermatitis (meaning the condition significantly affects daily activities and covers a considerable area of the body)
  • Must have either:
    • Not responded well enough to treatments applied directly to the skin (topical medications), or
    • Cannot use skin treatments for medical reasons, as determined by the study doctor
    • Must be an adult or elderly person (age ranges included in the study are adults and elderly)
    • Can be either male or female

Who cannot join the trial?

12 criteria

  • History of allergic reactions to similar medications or their components
  • Active skin infections or conditions that could interfere with evaluating atopic dermatitis (such as scabies, skin allergies other than atopic dermatitis)
  • Use of other treatments for atopic dermatitis in the past 4 weeks that could affect study results
  • Pregnant or breastfeeding women
  • Serious medical conditions that are not well-controlled (such as heart disease, liver problems, or kidney disease)
  • Participation in other clinical trials within the past 30 days
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Active or chronic infections (including tuberculosis, hepatitis B, hepatitis C, or HIV)
  • Mental health conditions that could interfere with following study procedures
  • Substance abuse or alcohol dependency within the past 6 months
  • Immunodeficiency conditions (weakened immune system) or use of medications that suppress the immune system
  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reaction)
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Investigated drugs

  • Pimecrolimus

    is a medication applied to the skin. It works by calming the immune system’s response in the skin, which helps to reduce redness, itching, and inflammation that occur in atopic dermatitis. In this study it is used as a background treatment that participants may already be using.

  • Tacrolimus

    is also a skin‑applied medication. Like pimecrolimus, it suppresses the immune activity in the skin to lessen the swelling, redness, and itchiness of atopic dermatitis. It is provided as part of the usual care for participants in the trial.

  • GHZ339

    is an investigational drug given by a subcutaneous injection (under the skin). It is being tested to see if it can improve the severity of atopic dermatitis compared with placebo. The study will evaluate how well it works and whether it is safe for patients with moderate to severe disease.

  • Topical corticosteroids

    are steroid creams or ointments that come in different strengths, ranging from weak to very strong. They are standard treatments for atopic dermatitis and are used in the trial as background therapy to control symptoms while the new drug is being tested.

What is already known about the treatment

  • Pimecrolimus

    This medication is applied as a topical cream that is rubbed onto the skin. It is an approved treatment for atopic dermatitis and works by blocking a protein called calcineurin, which reduces the activity of immune cells that cause inflammation. Pimecrolimus belongs to the class of topical calcineurin inhibitors and is listed in medical literature as a safe option for moderate to severe eczema.

  • Tacrolimus

    This drug comes as a topical ointment that is spread on affected skin areas. It is also an approved therapy for atopic dermatitis and acts by inhibiting calcineurin, thereby lowering the release of inflammatory signals from immune cells. Tacrolimus is classified as a topical calcineurin inhibitor and is widely referenced in clinical guidelines for eczema treatment.

  • GHZ339

    GHZ339 is given as a clear solution that is injected under the skin (subcutaneous injection). It is currently being studied in a Phase II trial for moderate to severe atopic dermatitis and is not yet approved for general medical use. The investigational drug is thought to work by modulating immune cells that drive skin inflammation, placing it in the experimental biologic/immune‑modulating drug class.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically appears as red, scaly patches that can occur anywhere on the body, but most commonly affects the face, hands, feet, and the bends of elbows and knees. It often begins in early childhood and can persist into adulthood, with symptoms that tend to flare up periodically. The condition is characterized by intense itching, which can lead to scratching and further skin damage. People with atopic dermatitis often experience periods of symptom improvement followed by periods of worsening, known as flares. The condition is part of the atopic triad, which includes asthma and hay fever.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519081-49-00Protocol codeCADPT17A12201Estimated enrolment228 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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