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Study of IMG-007 injection to treat moderate to severe atopic dermatitis in adults

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What is this study about?

This study focuses on testing a new medication called IMG-007 for people who have moderate-to-severe atopic dermatitis, which is a chronic skin condition causing red, itchy, and inflamed skin. The medication is given as a subcutaneous injection under the skin.

The purpose of this research is to evaluate how well different doses of IMG-007 work compared to placebo in treating atopic dermatitis. The study will examine if the medication can reduce the severity and extent of skin symptoms in adults with this condition. The medication will be tested over a period of 20 weeks to determine its effectiveness and safety.

During the study, participants will receive either IMG-007 or placebo through injections under the skin. The study is designed as a double-blinded trial, which means neither the participants nor the doctors conducting the study will know who receives the actual medication and who receives the placebo. Participants will be allowed to continue using regular moisturizers throughout the study period.

1 Initial assessment

Your participation begins with confirming that you have had atopic dermatitis for at least 1 year

A healthcare professional will assess if your condition qualifies as moderate-to-severe atopic dermatitis

You must be between 18 and 74 years old to participate

2 Treatment preparation

You will need to use a regular, non-medicated moisturizer throughout the study

Previous topical treatments must be discontinued

You will receive instructions about the subcutaneous injection (injection under the skin) procedure

3 Treatment phase

You will receive either IMG-007 or a placebo through subcutaneous injection

The treatment period lasts for 20 weeks

Neither you nor your doctor will know whether you are receiving IMG-007 or placebo

Regular assessments of your skin condition will be conducted using the Eczema Area and Severity Index (EASI)

4 Monitoring

Your skin condition will be evaluated at week 16 and week 20

Healthcare professionals will monitor any side effects throughout the study

The severity of your atopic dermatitis will be regularly assessed

You must report any changes in your health during the study period

5 Safety requirements

Female participants must not be pregnant or breastfeeding

Both male and female participants must use effective contraception methods during the study

Regular safety assessments will be conducted throughout the study period

Who Can Join the Study?

  • Age between 18 and 75 years old, both men and women can participate
  • Must be able to follow study procedures and provide written consent to participate
  • Must have Atopic Dermatitis (a chronic skin condition causing itchy, inflamed skin) diagnosed for at least 1 year
  • Must have active moderate-to-severe Atopic Dermatitis
  • Must have previously used topical treatments (medicines applied to the skin) such as:
    • Topical corticosteroids (anti-inflammatory creams or ointments) or
    • Topical calcineurin inhibitors (medicines that help control inflammation)

    These treatments either didn’t work well enough or caused side effects

  • Must agree to use a regular non-medicated moisturizer
  • For women who can become pregnant: must not be pregnant or breastfeeding and must use reliable birth control, or be unable to have children
  • For men: must use reliable birth control or be surgically sterilized

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • History of serious allergic reactions or anaphylaxis (severe, potentially life-threatening allergic reaction)
  • Active skin infection requiring treatment
  • Current diagnosis of skin cancer or pre-cancerous skin conditions
  • Pregnancy or breastfeeding
  • Use of systemic medications for atopic dermatitis (medications taken by mouth or injection that affect the whole body) within 4 weeks before study start
  • Participation in another clinical trial within the past 30 days
  • Significant medical conditions that could interfere with study participation, including:
    • Severe heart disease
    • Uncontrolled high blood pressure
    • Severe kidney or liver problems
    • Active cancer
  • History of substance abuse within the past year
  • Mental health conditions that could affect ability to follow study procedures
  • Known allergies to any of the study medication components

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Praglandia s.r.o. Prague Czechia
Hospital Del Mar Barcelona Spain
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Hospital General De Granollers Granollers Spain
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Dermatologikum Hamburg GmbH Hamburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Clinexpert Kft. Budapest Hungary
Pratia Pardubice a.s. Pardubice Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Tnbmochy Nwkh Scw z orlk Warsaw Poland
Uqrrlhhoovbfshpbelnyb Aalaiorj Augsburg Germany
Bqsfdzcyrrd Vdgswjvcn Ojqhrclcsudf Kecskemet Hungary
Gwamep Uvgsptbbvw Fvhbvwnic Frankfurt Germany
Lnemqjf Stjbwskmuxdybwq Gktrzma Dwhfbxhmwdqwndr Lublin Poland
Dkpohbewbrpagdvtwesv oyybxlcd Mmzej Bpiwhf Hxcjilydswu Psft Prague Czechia

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
30.09.2025
Germany Germany
Not yet recruiting
30.09.2025
Hungary Hungary
Not yet recruiting
30.09.2025
Poland Poland
Not yet recruiting
30.09.2025
Spain Spain
Not yet recruiting
30.09.2025

Trial locations

Investigated drugs:

Based on the provided trial data, there is only one active medication involved in the trial:

IMG-007 is an investigational drug being studied for treating moderate to severe atopic dermatitis (a type of eczema). This medication is being tested to see how well it can reduce the severity and affected areas of eczema in adult patients. It is being compared to placebo to determine its effectiveness in controlling disease activity and improving symptoms of atopic dermatitis.

Investigated diseases:

Atopic Dermatitis – A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in early childhood but can occur at any age, often appearing in patches on the face, hands, feet, and behind the knees and elbows. Atopic dermatitis follows a pattern of flare-ups and remissions, where symptoms can worsen for a period and then improve. The condition makes the skin barrier more sensitive and less able to retain moisture, leading to dry and easily irritated skin. Environmental factors, stress, and allergens can trigger flare-ups of the condition.

Trial ID:
2024-520117-50-00
Protocol code:
IMG-007-203
Trial Phase:
Therapeutic exploratory (Phase II)

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