Not recruiting

Study on the Effectiveness and Safety of ANB032, Betamethasone Dipropionate, and Hydrocortisone for Patients 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 clinical trial is focused on studying the treatment of Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed skin. 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 condition. Participants in the study will receive either the ANB032 treatment or a placebo, which is a substance with no active medication.

The purpose of the study is to assess how well ANB032 works compared to the 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 for ANB032 will last up to 12 weeks, with follow-up visits to track progress and any changes in the condition.

In addition to ANB032, the study will also involve the use of Betamethasone Dipropionate and Hydrocortisone, which are topical treatments applied to the skin. These are commonly used to reduce inflammation and relieve itching. The study aims to provide valuable information on the effectiveness of ANB032 in managing atopic dermatitis and improving the quality of life for those affected by this condition.

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 specific criteria such as age, health status, and severity of atopic dermatitis.
The condition must be moderate to severe, with a history of inadequate response to certain treatments.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of atopic dermatitis using specific scores like EASI and vIGA-AD.
The extent of the affected body area is also measured.
Step 3
Randomization and treatment allocation
Participants are randomly assigned to receive either the investigational drug ANB032 or a placebo.
The study is double-blind, meaning neither the participants nor the researchers know who receives the actual drug.
Step 4
Treatment administration
The investigational drug ANB032 is administered through subcutaneous injection.
The frequency and dosage are determined by the study protocol.
Step 5
Ongoing monitoring
Regular monitoring is conducted to assess the efficacy and safety of the treatment.
Participants are evaluated for any changes in their condition and any side effects.
Step 6
Final assessment
At the end of the study period, a final assessment is conducted to measure the improvement in the condition.
The primary endpoint is the proportion of participants achieving a significant reduction in the EASI score.

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 both topical corticosteroids and topical calcineurin inhibitors, or if these treatments are not suitable for medical reasons. Topical corticosteroids are creams or ointments used to reduce skin inflammation. Topical calcineurin inhibitors are creams or ointments that help control the immune response in the skin.
Must have an EASI score of 16 or higher at the time of screening and when starting the study. The EASI score is a measure used to assess the severity of eczema.
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 to evaluate the overall 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. Body surface area (BSA) refers to the percentage of the body affected by the condition.

Who cannot join the trial?

7 criteria

Patients who have other skin conditions that might interfere with the study.
Patients who have used certain medications recently that could affect the study results.
Patients with a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with certain medical conditions that could make participation unsafe.
Patients who are unable to follow the study procedures.

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Verified sites

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

Clintrial s.r.o.
Verified
Prague, Czechia
Diamond Clinic Sp. z o.o.
Responsive
Cracow, Poland
Not recruiting
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
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. It is designed to help reduce the symptoms of this skin condition, which can include redness, itching, and inflammation. The trial aims to evaluate how effective and safe ANB032 is for patients suffering from this type of dermatitis.

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 chronic skin condition characterized by inflammation and itching. At the molecular level, ANB032 works by targeting specific pathways in the immune system 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 involves a combination of genetic and environmental factors.