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Study to evaluate ATI-045 injection compared to placebo in adults with 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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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)
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Badan Klinicznych Pi-House Sp. z o.o.
Verified
Gdansk, Poland
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Responsive
Sosnowiec, Poland
Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany

Trial locations

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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.

HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN

What is already known about the treatment

ATI-045 – An investigational medication currently being studied in clinical trials for the treatment of moderate-to-severe atopic dermatitis (eczema). While the specific method of administration is not provided in the source data, this experimental drug is being evaluated for its effectiveness in reducing the severity and extent of eczema symptoms, particularly as measured by the Eczema Area and Severity Index (EASI) score. The medication is being tested in a randomized, double-blinded, placebo-controlled study, which represents the gold standard for clinical research methodology. As this is an investigational drug, it is not yet approved for general medical use, and its complete safety and efficacy profile is still being established through clinical trials.

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.