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Study on the Effectiveness and Safety of ANB032, Hydrocortisone, and Alclometasone Dipropionate for Patients with Moderate to Severe Atopic Dermatitis

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate a new treatment called ANB032, which is a solution for injection, to see how effective and safe it is for people with moderate to severe forms of this skin condition. Participants in the study will receive either the ANB032 treatment or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to assess how well ANB032 works compared to a placebo in improving the symptoms of atopic dermatitis. The study will involve regular visits where participants will receive injections and have their skin condition monitored by healthcare professionals. The treatment period will last for several weeks, during which the changes in the severity of the skin condition will be carefully observed and recorded.

In addition to ANB032, the study will also involve the use of Hydrocortisone and Alclometasone Dipropionate, which are common treatments for skin inflammation, applied to the skin as needed. These medications are used to help manage symptoms and provide relief from itching and redness. The study aims to provide valuable information on the potential benefits of ANB032 for individuals suffering from atopic dermatitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, health status, and severity of atopic dermatitis.
The study is designed for individuals aged 18 to 65 with moderate to severe atopic dermatitis.
Step 2
Randomization
Participants are randomly assigned to receive either the investigational medication ANB032 or a placebo.
This process ensures that the study results are unbiased.
Step 3
Treatment phase
The treatment involves receiving ANB032 through subcutaneous injection.
The frequency and dosage of the injections are determined by the study protocol.
Step 4
Use of topical medications
Participants may also use topical medications such as hydrocortisone or alclometasone dipropionate for cutaneous application.
These medications are applied to the skin as directed by the study guidelines.
Step 5
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.
The primary measure of success is the change in the Eczema Area and Severity Index (EASI) at Week 14.
Step 6
Completion of the study
The study is expected to conclude by November 30, 2024.
Participants will have a final assessment to determine the overall impact of the treatment.

Who can join the trial?

6 criteria

Must be a male or female aged between 18 to 65 years and in good general health.
Must have had moderate or severe atopic dermatitis for at least 6 months before joining the study. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
Must have a history of not responding well to treatment for atopic dermatitis with creams or ointments, or for whom these treatments are not suitable for medical reasons.
Must have an EASI score of 16 or higher at the time of screening and when starting the study. The EASI score is a way to measure the severity of eczema, which is another name for atopic dermatitis.
Must have a vIGA-AD score of 3 or higher at the time of screening and when starting the study. The vIGA-AD score is a tool used by doctors to assess the severity of atopic dermatitis.
Must have at least 10% of their body surface area affected by atopic dermatitis at the time of screening and when starting the study. This means that at least 10% of the skin is involved with the condition.

Who cannot join the trial?

4 criteria

Individuals who do not have moderate to severe atopic dermatitis cannot participate. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
Participants must be within the specified age range for the study.
Both males and females are eligible, but certain conditions may exclude participation.
Individuals who are part of a vulnerable population may be excluded. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland
Not yet recruiting
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

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Investigated drugs

ANB032 is an investigational medication being studied for its potential to treat moderate to severe atopic dermatitis. This medication is being tested to see if it can help reduce the symptoms of atopic dermatitis, which is a condition that causes the skin to become red, itchy, and inflamed. The study aims to determine how effective and safe ANB032 is for people suffering from this skin condition.

What is already known about the treatment

ANB032 – ANB032 is administered as an injection, typically given under the skin. It is currently in the clinical trial phase, specifically a Phase 2 study, to evaluate its effectiveness and safety for treating moderate to severe atopic dermatitis. The main therapeutic indication for ANB032 is atopic dermatitis, a condition characterized by inflamed, itchy skin. At the molecular level, ANB032 works by targeting specific immune pathways to reduce inflammation and alleviate symptoms. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.