#1 Clinical Trials Search in Europe

Study to evaluate ATI-045 injection compared to placebo in adults with moderate to severe atopic dermatitis

2 1

What is this study about?

This study focuses on patients with moderate-to-severe atopic dermatitis, a chronic skin condition causing itchy, inflamed, and scaly rashes. The research evaluates a new medication called ATI-045, which is a humanized monoclonal antibody given as a subcutaneous injection under the skin.

The purpose of this research is to determine how well ATI-045 works compared to placebo in treating atopic dermatitis symptoms. During the study, participants will receive either ATI-045 or placebo injections for a period of 24 weeks. The maximum daily dose of the medication will be 600 mg, with a total maximum dose of 4200 mg over the treatment period.

The medication being tested works by targeting a specific protein in the body called thymic stromal lymphopoietin, which plays a role in causing inflammation in atopic dermatitis. Throughout the study, doctors will monitor how well the treatment works by measuring changes in the severity and extent of skin symptoms. They will also track any side effects that may occur during the treatment period.

1 Initial assessment

You will undergo an evaluation to confirm that you have had atopic dermatitis for at least 6 months

Your skin condition will be assessed using specific measurements including the EASI score (a tool that measures the severity and extent of eczema) which must be 16 or higher

At least 10% of your body surface area must be affected by atopic dermatitis

Your itching severity will be evaluated using a numerical scale

2 Treatment assignment

You will be randomly assigned to receive either ATI-045 or a placebo (inactive substance)

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

The medication will be given as an injection under the skin (subcutaneous injection)

3 Treatment period

The treatment period will last for 24 weeks

You will need to continue using your regular non-medicated moisturizer daily throughout the study

Regular assessments of your skin condition will be performed

Your itching severity will be monitored using a daily rating scale

4 Monitoring and assessments

Your skin condition will be regularly evaluated using the EASI score

The affected body surface area will be measured

Blood tests will be performed to monitor your health

Heart measurements (ECG) and vital signs will be checked

Any side effects will be recorded and monitored

5 Final evaluation

After 24 weeks, a final assessment of your skin condition will be performed

The effectiveness of the treatment will be measured by comparing your final EASI score to your initial score

Your overall response to the treatment will be evaluated

Final safety assessments will be conducted

Who Can Join the Study?

  • Age between 18 and 70 years old
  • Must have had atopic dermatitis for at least 6 months before screening, with no major disease flare-ups in the 4 weeks before screening
  • Must have a moderate to severe form of atopic dermatitis, as measured by specific medical scales:
    – EASI score of 16 or higher (a tool that measures the severity and extent of eczema)
    – vIGA score of 3 or higher (a scale that evaluates the overall severity of the condition)
    – Affected body surface area of at least 10%
    – Average daily itch intensity score of 4 or higher in the week before starting
  • Must have previously tried topical treatments (medications applied to the skin) with inadequate results or have a medical reason why these treatments are not suitable
  • Must have been using non-medicated moisturizer regularly for at least 7 days before starting and agree to continue using it throughout the study
  • Must be willing to have photographs taken of affected skin areas
  • Must be able to attend all clinic visits and complete all study procedures
  • Must provide written informed consent to participate
  • For sexually active participants:
    – Men must agree to use condoms and effective contraception for 180 days after the last dose
    – Women who can become pregnant must use effective contraception for 120 days after the last dose

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Active skin infections or other skin conditions that could interfere with evaluating atopic dermatitis
  • Use of systemic medications for atopic dermatitis within 4 weeks before study start
  • Use of topical treatments for atopic dermatitis within 2 weeks before study start
  • Significant medical conditions that could affect study participation (such as severe heart, liver, or kidney disease)
  • Participation in another clinical trial within the past 30 days
  • Known immune system disorders
  • History of cancer in the past 5 years
  • Unable to follow study procedures or attend scheduled visits
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland
Sanatorium profesora Arenbergera Prague Czechia
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Josef-Hospital Bochum Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Rosenpark Research GmbH Darmstadt Germany
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Pratia Pardubice a.s. Pardubice Czechia
Clintrial s.r.o. Prague Czechia
Prywatna Praktyka Lekarska Ewa Ring Warsaw Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Kises aajdtpvya Fzjrexy sjryza Prague Czechia
Chfsbud Bdkxf Ktgitrczzxj Pvuiwcbt Sae z okxc Gdansk Poland
Tbjjdieildk uzx Sklbywxibqw Bshvfoik Gvpo Bad Bentheim Germany
Cdw Mli Chgeco Plock Poland
Mcptcfwqdze Uhsxg Sjs z owhg Warsaw Poland
Dlrqphodsu Mgcychm Dsyalvkqpnn Csbfjl Dy Nc Mihv Epnoq Gdewza Chorzow Poland
Gorssm Ukuabwlroz Fnlpasodf Frankfurt Germany
Ztvktje Mrx Suk z oeli Lublin Poland

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
15.08.2025
Germany Germany
Not yet recruiting
15.08.2025
Poland Poland
Not yet recruiting
15.08.2025

Trial locations

Investigated drugs:

ATI-045 is an investigational medication being studied for the treatment of moderate-to-severe atopic dermatitis (also known as eczema). This medication is being tested to see how well it works in reducing the severity and area of eczema symptoms compared to placebo. The exact mechanism of how this medication works is not specified in the trial information, but it aims to help patients who have not responded well enough to other treatments for their atopic dermatitis.

Investigated diseases:

Atopic Dermatitis – A chronic inflammatory skin condition that causes itchy, red, swollen, and cracked skin. The condition typically begins in childhood and can continue through adulthood, occurring in periodic flare-ups. It makes the skin very sensitive and prone to dryness, with affected areas often appearing darker or redder than the surrounding skin. The condition commonly appears on the face, hands, feet, and in body areas where the skin flexes, such as inside the elbows and behind the knees. People with atopic dermatitis often experience intense itching, which can lead to scratching and further skin damage.

Trial ID:
2024-520302-19-00
Protocol code:
ATI-045-AD-201
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Sweden

  • Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain