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Study on the Effectiveness and Safety of Lebrikizumab for Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

Fast replyInvestigational

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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 effects of a treatment for Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called Lebrikizumab, which is a type of medication known as a monoclonal antibody. This medication is given as a solution for injection under the skin.

The purpose of the study is to evaluate how effective and safe Lebrikizumab is for people with moderate-to-severe Atopic Dermatitis. Participants in the study will receive the treatment over a period of 24 weeks. During this time, researchers will monitor changes in the severity of the disease, as well as any signs and symptoms experienced by the participants.

Throughout the study, participants will have regular visits to assess their progress and any improvements in their condition. The study aims to gather information on how well Lebrikizumab works in reducing the symptoms of Atopic Dermatitis and improving the quality of life for those affected by this condition.

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, weight, and medical history related to atopic dermatitis.
The assessment ensures that the condition has been present for at least one year and that previous treatments were inadequate.
Step 2
Baseline visit
During the baseline visit, the severity of the condition is evaluated using specific scores such as EASI and IGA.
Participants must have an EASI score of at least 12 and an IGA score of at least 3.
Step 3
Treatment initiation
The treatment involves the administration of lebrikizumab, a solution for injection, given subcutaneously.
The treatment period lasts for 24 weeks, during which the effectiveness and safety of the medication are monitored.
Step 4
Ongoing assessments
Throughout the study, regular assessments are conducted to monitor progress. These include evaluating changes in EASI and IGA scores.
Participants are required to complete electronic diary entries to track symptoms such as itching and sleep loss.
Step 5
Final evaluation
At the end of the 24-week treatment period, a final evaluation is conducted to assess the overall effectiveness of the treatment.
The primary goal is to achieve a significant reduction in the EASI score, with secondary goals including improvements in other related symptoms.

Who can join the trial?

10 criteria

Adults and adolescents aged 12 to less than 18 years old, who weigh at least 40 kg, and are suitable for treatments that affect the whole body for **Atopic Dermatitis**.
The participant must sign a form agreeing to join the study. Adolescents need to sign a separate form or the same form as their parent or guardian, depending on local rules.
Have had **Chronic Atopic Dermatitis** for at least 1 year before the first screening visit. This is a long-lasting skin condition.
Have an **EASI score** of 12 or higher at the first visit. EASI is a way to measure the severity of eczema.
Have an **IGA score** of 3 or higher at the first visit. IGA is a scale from 0 (clear skin) to 4 (severe eczema) to rate the condition.
At least 10% of the body surface area is affected by Atopic Dermatitis at the first visit.
Have a history of not responding well to creams or ointments, or if these treatments are not suitable for medical reasons.
Complete entries in an electronic diary about itching and sleep loss for at least 4 out of 7 days before the first visit.
Be willing and able to attend all clinic visits and follow all study-related procedures and fill out questionnaires.
For women who can have children: agree to not have heterosexual intercourse or use a highly effective birth control method during the treatment and for at least 4 weeks or one menstrual cycle after the last dose of the study medication. This includes methods like hormonal birth control, intrauterine devices, or having a partner who has had a vasectomy.

Who cannot join the trial?

8 criteria

Patients with certain other skin conditions that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics or other medications.
Patients who have used certain medications that might affect the study results.
Patients with a history of certain serious health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have not followed the study instructions or requirements in the past.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Studienzentrum Dr. Beate Schwarz
Langenau, Germany
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Lebrikizumab is a medication being studied for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, which is a type of eczema. This medication is designed to help reduce the severity of the disease, as well as improve the signs and symptoms associated with it. The study focuses on how well this treatment works over a period of 24 weeks in both adults and adolescents.

Lebrikizumab

What is already known about the treatment

Lebrikizumab – Lebrikizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, a chronic skin condition. The medication works by targeting and inhibiting a specific protein involved in the inflammatory process, helping to reduce symptoms like itching and skin lesions. Lebrikizumab is classified as a monoclonal antibody, a type of medication designed to specifically target certain molecules in the body.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis 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 tends to flare periodically and then subside, with symptoms varying in severity. Commonly affected areas include the face, neck, and the insides of the elbows and knees. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The condition is often associated with other allergic disorders such as asthma and hay fever.