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Study on Tralokinumab for Children Aged 6-11 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 atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. The trial is specifically for children aged 6 to under 12 years who have moderate to severe forms of this condition. The treatment being tested is called tralokinumab, which is given as an injection under the skin. Tralokinumab is also known by the code name CAT-354 and is provided in a pre-filled syringe for easy use.

The purpose of the study is to understand how tralokinumab behaves in the body and to assess its safety in children with atopic dermatitis. Participants in the study will receive multiple doses of the medication over a period of time. The study will be conducted in phases, starting with an initial treatment period lasting up to 16 weeks, followed by an open-label treatment period, and finally a long-term extension period. During these phases, the effects of the medication will be monitored, including any side effects and the presence of anti-drug antibodies, which are proteins the body might produce in response to the medication.

Throughout the study, changes in the severity of atopic dermatitis will be measured using various scoring systems. These include the Eczema Area and Severity Index (EASI), which assesses the extent and severity of the condition, and the Patient-Oriented Eczema Measure (POEM), which evaluates the impact of the condition on daily life. The study aims to provide valuable information on the effectiveness and safety of tralokinumab for treating children with moderate to severe atopic dermatitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
The trial begins with the initial treatment period, which lasts from Week 0 to Week 16.
During this period, the medication Adtralza (tralokinumab) is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol.
The primary goal is to evaluate the medication's effects and safety in children with moderate-to-severe atopic dermatitis.
Step 2
Open-label treatment period
Following the initial treatment period, the open-label treatment period extends from Week 16 to Week 68.
During this phase, the same medication is continued, and the effects are monitored.
The focus is on observing any treatment-emergent adverse events and the presence of anti-drug antibodies.
Step 3
Long-term extension treatment period
The long-term extension treatment period begins at Week 68 and continues until the end of the treatment visit.
This phase aims to assess the long-term safety and effectiveness of the medication.
The end-of-treatment visit occurs two weeks after the last dose of the medication.
Step 4
End-of-treatment visit
The end-of-treatment visit is conducted two weeks after the final dose of the medication.
This visit is crucial for evaluating the overall outcomes and any lasting effects of the treatment.

Who can join the trial?

9 criteria

The child must have a diagnosis of Atopic Dermatitis (AD), which is a skin condition, according to specific criteria called Hanifin and Rajka.
The child should be between 6 and less than 12 years old.
The child must weigh at least 17 kilograms at the start of the study.
The child should have had AD for at least 12 months before the study begins.
The child must have tried treatments called Topical Corticosteroids (TCS) or Topical Calcineurin Inhibitors (TCI) and found them not effective or not suitable, or these treatments should not be recommended for them.
The child's AD should cover at least 10% of their body at the start of the study and during the initial check.
The child should have an Eczema Area and Severity Index (EASI) score of 16 or higher at the start of the study and during the initial check. This score measures the severity of eczema.
The child should have an Investigator's Global Assessment (IGA) score of 3 or higher at the start of the study and during the initial check. This score helps assess the overall severity of the skin condition.
The child must have used a moisturizer, also known as an emollient, at least twice a day for at least 14 days before the study starts.

Who cannot join the trial?

7 criteria

Children who have other skin conditions that might interfere with the study.
Children who have had a serious allergic reaction to similar medications in the past.
Children who are currently taking other medications that might affect the study results.
Children who have a history of certain medical conditions that could make participation unsafe.
Children who have received certain treatments for atopic dermatitis recently.
Children who have participated in another clinical trial recently.
Children who have any condition that the study doctors believe would make participation unsafe or affect the study results.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Verified
Fakultni Nemocnice Brno
Brno, Czechia
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Tralokinumab is a medication being studied for its effects on children with moderate to severe atopic dermatitis, which is a type of eczema. This trial aims to understand how the body processes the medication and to assess its safety when given as a single therapy. Tralokinumab works by targeting and blocking a specific protein in the body that is involved in the inflammation process, which can help reduce the symptoms of atopic dermatitis.

Tralokinumab

What is already known about the treatment

Tralokinumab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its use in treating moderate-to-severe atopic dermatitis, particularly in children aged 6 to under 12 years. Tralokinumab is a monoclonal antibody that works by targeting and neutralizing interleukin-13, a protein involved in the inflammatory process of atopic dermatitis. It is classified as an immunomodulator, and its effectiveness and safety are being evaluated to better understand its pharmacokinetics in pediatric patients.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, often referred to as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It commonly appears in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in severe cases, it can lead to blisters and oozing. The condition tends to flare up periodically, with symptoms worsening at times and then improving. Environmental factors, allergens, and stress can trigger or exacerbate the symptoms. Over time, repeated scratching can lead to thickened skin and increased pigmentation.