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 study about?

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.

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.

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.

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.

4 treatment administration

The investigational drug ANB032 is administered through subcutaneous injection.

The frequency and dosage are determined by the study protocol.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Sanatorium profesora Arenbergera	Prague	Czechia
NZOZ Przychodnia Specjalistyczna A-DERM-Serwis	Czestochowa	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne	Swidnik	Poland
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Clintrial s.r.o.	Prague	Czechia
Praglandia s.r.o.	Prague	Czechia
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Pratia Pardubice a.s.	Pardubice	Czechia
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna	Warsaw	Poland
Mqfslmwlk Iqkacdhndr Ckjatanm Sxebhhqy Sux z omie	Warsaw	Poland
Ltcir Czmzxa Scnk dd Tfcuwp Kjuqjaikood dw Awsjzhn Kzxgnmhu	Szczecin	Poland
Uqbjohajkrijgo Cnuxvgy Kcfbmtlux	Gdansk	Poland
Djzfughxua Sjd z otqq	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.03.2024
Poland	Not recruiting	01.03.2024

Trial locations

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.

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.

Trial ID:

2023-503522-40-01

Protocol code:

ANB032-201

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?