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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Technische Universitaet Dresden	Dresden	Germany
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Universitaet Leipzig	Leipzig	Germany
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Praglandia s.r.o.	Prague	Czechia
Medical Center Hera EOOD	Sofia	Bulgaria
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Santa Sp. z o.o.	Lodz	Poland
Fakultni Nemocnice Bulovka	Prague	Czechia
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Dermamedica s.r.o.	Nachod	Czechia
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
UNIMED Medical Center EOOD	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Clintrial s.r.o.	Prague	Czechia
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Pratia S.A.	Skorzewo	Poland
University Of Pecs	Pecs	Hungary
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
University Hospital Ostrava	Ostrava	Czechia
Dermedic Iwona Zdybska	Lublin	Poland
Medical Center Medconsult Pleven OOD	Lovech	Bulgaria
Kdtgm afcmpzapi Footbzi sceqsm	Prague	Czechia
Ttwocuvrvnj ucx Sutjviweimk Bswoearw Gsfv	Bad Bentheim	Germany
Dfkqyvslyscxfocrgjlh ohupwhvb Momct Bxezwq Hodlngnhxnp Ptjy	Prague	Czechia
Dygfuetln Shv z oqgp	Wroclaw	Poland
Galnyh Ujksdngqox Ftzasxmvz	Frankfurt	Germany
Mkjdwjxd Mgtggju Atqtuuc	Pleven	Bulgaria
Ditlmacudo Mbashow Dzzlvggehtr Cpizwq Dd Nl Mbua Eilzz Gdcwel	Chorzow	Poland
Mlkraza Cszanl Mgjagrmrhw Ppcdfg Ote	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	14.04.2026
Czechia	Recruiting	14.04.2026
Germany	Recruiting	14.04.2026
Hungary	Recruiting	14.04.2026
Poland	Recruiting	14.04.2026

Trial locations

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.

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 ID:

2025-522578-35-00

Protocol code:

ATD002

Trial Phase:

Therapeutic exploratory (Phase II)

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A study to evaluate the safety and effectiveness of galvokimig in adults with moderate to severe atopic dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?