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Study on the Safety and Effectiveness of ADX-914 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 condition known as Atopic Dermatitis, which is a type of eczema that causes the skin to become red, itchy, and inflamed. The study is specifically looking at individuals with moderate to severe forms of this condition. The treatment being tested is called ADX-914, which is a solution for injection. ADX-914 is a type of protein known as a monoclonal antibody that targets a specific part of the immune system involved in the inflammation process. The study will compare the effects of ADX-914 with a placebo to understand its safety and effectiveness.

The purpose of the study is to evaluate how well ADX-914 works in reducing the symptoms of atopic dermatitis and to determine the best dose for treatment. Participants in the study will receive either ADX-914 or a placebo through subcutaneous injections, which means the injection is given under the skin. The study will be conducted over several weeks, with regular check-ups to monitor the participants' health and the condition of their skin. The main goal is to see if there is a significant improvement in the skin condition of those receiving ADX-914 compared to those receiving the placebo.

Throughout the study, the safety of ADX-914 will be closely monitored by checking for any side effects or adverse reactions. Participants will undergo various assessments, including physical examinations and tests, to ensure their well-being. The study aims to provide valuable information on the potential benefits of ADX-914 for people suffering from moderate to severe atopic dermatitis, offering hope for a new treatment option in the future.

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
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, disease duration, and severity of atopic dermatitis.
Eligibility criteria include being 18 years or older, having a chronic condition for at least 3 years, and meeting specific disease activity levels.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the investigational drug ADX-914 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment administration
The treatment involves subcutaneous injections. The specific dosage and frequency are determined during the study, with the aim of identifying the optimal dose for ADX-914.
The placebo is administered in the same manner as ADX-914 to maintain the study's integrity.
Step 4
Monitoring and follow-up
Participants are monitored regularly to assess the safety and effectiveness of the treatment. This includes checking for any adverse events and evaluating changes in the severity of atopic dermatitis.
Assessments occur at various intervals, including weeks 4, 8, 12, 14, 16, and 24, to measure changes in the Eczema Area and Severity Index (EASI) and other relevant scores.
Step 5
Completion of study
The study concludes with a final evaluation of the treatment's impact on atopic dermatitis. This includes a comprehensive review of all collected data to determine the overall safety and efficacy of ADX-914 compared to the placebo.

Who can join the trial?

8 criteria

Must be **18 years or older** at the time of giving consent to participate.
Must have had **chronic atopic dermatitis** for at least **3 years**, diagnosed using specific criteria.
Must have **moderate to severe disease activity** at the start of the study, defined as:
- **Body Surface Area (BSA)** affected by at least **10%**.
- **Eczema Area and Severity Index (EASI) Score** of at least **12**.
- **Investigator's Global Assessment (IGA) Score** of at least **3**.
- Must have a history of not responding well to at least one of the following treatments:
  - A **4-week course** of medium-strength creams or ointments, or other approved topical treatments.
  - **Systemic steroids** or **light therapy**.
  - **Oral medications** that affect the immune system, such as methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, or approved systemic biologic treatments like dupilumab, ustekinumab, or tralokinumab, or approved systemic targeted synthetic JAK inhibitors like upadacitinib or abrocitinib.

Who cannot join the trial?

9 criteria

Patients with other skin conditions that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have used certain medications 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 a history of drug or alcohol abuse.
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

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Poland

Trial locations

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Investigated drugs

ADX-914 is a medication being studied for its potential to treat moderate to severe atopic dermatitis, a condition that causes inflamed, itchy skin. The trial aims to determine the best dose of ADX-914 and to evaluate how effective it is in improving the symptoms of this skin condition.

Bempikibart

What is already known about the treatment

ADX-914 – ADX-914 is administered as an injection, typically under the skin. It is currently being studied in clinical trials, specifically in a Phase 2a study, to assess its safety and effectiveness for treating moderate to severe atopic dermatitis, a skin condition characterized by inflammation and itching. The medication works by targeting specific pathways in the immune system to reduce inflammation and improve skin symptoms. It is classified as an immunomodulatory agent, which means it helps regulate the immune response to prevent excessive inflammation.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood but can occur at any age. The disease progresses through cycles of flare-ups and remissions, where symptoms can worsen and then improve or clear up. The skin may become dry, cracked, and prone to infections due to frequent scratching. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. Over time, the skin may thicken and become more leathery due to chronic inflammation and scratching.