Study of GHZ339 for treatment of moderate to severe atopic dermatitis

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Universitario 12 De Octubre Madrid Spain
Fakultni Nemocnice Bulovka Prague Czechia
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Fakultni Nemocnice Plzen Plzen Czechia
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Maxderm s.r.o. Bardejov Slovakia
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Medikard s.r.o. Presov Slovakia
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Groupe Hospitalier Bretagne Sud Lorient France
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Klinische Forschung Osnabrueck Osnabrück Germany
Polyclinique Courlancy-Bezannes Reims France
University Of Szeged Szeged Hungary
Pvzsjs Fhff Dvzxfohjxwuw Uvm Vumctvbuakh Dresden Germany
Ujukdxizpf Mkalrtl Ckehrw Heiymqdpbbccoipyp Hamburg Germany
Hbsoqquh Uxjoismupjxlg Dm Li Phqzvirq Madrid Spain
Tzcmyytljxl udp Sunfnbubtah Bhkwmkjf Gyjs Bad Bentheim Germany
Acvssd Hdl sjntya Komarno Slovakia
Awxgiz swgqon Kosice Slovakia
Fudqhudo nnlpiydzb Mcdjw a Hbdihtq Prague Czechia
Asmjxaabqy Pocjtfnp Hodmppta De Pqihz Paris France
Eedyihs Uccgpvvqypmf Mzjrxwt Cpqnwfv Rzyxbgeee (ppudkoy Muy Rotterdam The Netherlands
Uconfbidmpoijeaifehgf Mzczcdxt Amq Munster Germany
Guocgf Ulftajxikd Frqgncogt Frankfurt Germany
Pymxdin Swy z obdz Katowice Poland
Hazbyofi Unrkpdduhuhte Hftxaosf Twkgr y Pjadtg Ivqgvzmf Clshzd dorfpunqlbazgmqhc (errb Badalona Spain
Lamhfrn Sfhqypqokfudwlc Ggnxatr Dxypieqhbgvyhbm Lublin Poland
Dybwfpxhjpta Qmkuf Mainz Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
22.09.2025
France France
Recruiting
22.09.2025
Germany Germany
Recruiting
22.09.2025
Hungary Hungary
Recruiting
22.09.2025
Italy Italy
Recruiting
22.09.2025
Poland Poland
Recruiting
22.09.2025
Slovakia Slovakia
Recruiting
22.09.2025
Spain Spain
Recruiting
22.09.2025
The Netherlands The Netherlands
Recruiting
22.09.2025

Trial locations

Investigated drugs:

Since the provided data does not contain specific information about medications or therapies used in the trial, I can only provide a general description based on what is mentioned in the trial title and objective:

This clinical trial focuses on investigating unspecified investigational compounds for treating atopic dermatitis (a type of eczema). The trial compares these experimental medications to a placebo to see how well they work in treating moderate to severe atopic dermatitis symptoms. The main goal is to understand how different doses affect the improvement in skin condition, measured by something called the EASI score over 16 weeks.

Without more specific information about the medications being tested, I cannot provide detailed descriptions of individual treatments.

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 ID:
2024-519081-49-00
Protocol code:
CADPT17A12201
Trial Phase:
Therapeutic exploratory (Phase II)

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