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

Fast replyRegistered drugNo placebo

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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 effectiveness and safety 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. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. In this study, Lebrikizumab is given as a solution for injection, either in a pre-filled pen or syringe.

The purpose of the study is to evaluate how well Lebrikizumab works in reducing the severity of atopic dermatitis symptoms in both adults and adolescents. Participants will receive the treatment over a period of 24 weeks. During this time, they will have regular visits to monitor their condition and any changes in their symptoms. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study aims to see if Lebrikizumab can help improve the skin condition and overall quality of life for those with moderate-to-severe atopic dermatitis. Participants will be assessed on various aspects, such as the extent of skin improvement and relief from itching. The study will also look at how the treatment affects sleep and daily activities, providing a comprehensive view of its impact on the participants' lives.

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, the participant will be required to provide informed consent. Adolescents will also need to provide informed assent.
Eligibility is confirmed based on criteria such as age, weight, and a history of atopic dermatitis that has been present for at least one year.
Step 2
Baseline assessment
A baseline visit will be conducted to assess the severity of atopic dermatitis using scores like EASI and IGA.
Participants must have completed electronic diary entries for symptoms like itching and sleep loss for at least four days before this visit.
Step 3
Treatment initiation
Participants will begin treatment with lebrikizumab, administered as a 250 mg solution for injection.
The medication is given subcutaneously, which means it is injected under the skin.
Step 4
Treatment duration
The treatment will continue for a total of 24 weeks.
Participants will receive regular injections throughout this period.
Step 5
Regular assessments
Throughout the study, regular assessments will be conducted to monitor the effectiveness and safety of the treatment.
These assessments will include evaluating changes in disease severity, symptoms, and quality of life.
Step 6
End of treatment evaluation
At the end of the 24-week treatment period, a final evaluation will be conducted.
The primary goal is to determine the percentage of participants achieving a significant improvement in their EASI score.

Who can join the trial?

10 criteria

Adults and adolescents aged 12 to less than 18 years old, weighing at least 40 kg, who are suitable for treatments that affect the whole body for **Atopic Dermatitis**.
Participants must sign a form agreeing to join the study. Adolescents need to provide their own agreement and sign a separate form or the same form as their parent or guardian, depending on local rules.
Must have had **Chronic Atopic Dermatitis** for at least 1 year before the first screening visit. This is a long-lasting skin condition diagnosed using specific criteria.
Must have an **EASI score** of 12 or higher at the first visit. This score measures the severity of eczema.
Must have an **IGA score** of 3 or higher at the first visit. This score rates the overall appearance of the skin on a scale from 0 (clear) to 4 (severe).
Must have **10% or more of the body surface area** affected by Atopic Dermatitis at the first visit.
Must have a history of not responding well to treatments applied directly to the skin, or these treatments are not suitable for medical reasons.
Must have completed entries in an electronic diary about itching and sleep loss for at least 4 out of 7 days before the first visit.
Must be willing and able to attend all clinic visits and follow all study-related procedures and fill out questionnaires.
For women who can become pregnant: Must use highly effective birth control methods, such as hormonal contraception, intrauterine devices, or other reliable methods, or practice sexual abstinence.

Who cannot join the trial?

10 criteria

Patients with 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 with certain infections that are not well controlled.
Patients with a history of certain immune system disorders.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients with certain chronic diseases that are not stable.
Patients who are unable to follow the study procedures.

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Verified sites

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Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario De Jaen
Jaen, Spain

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, a type of eczema. It is designed to help reduce the severity of the disease, as well as alleviate the signs and symptoms associated with it. This study aims to understand how well lebrikizumab works over a 24-week period in both adults and adolescents.

Lebrikizumab

What is already known about the treatment

Lebrikizumab – This medication is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic dermatitis. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for lebrikizumab is atopic dermatitis, a chronic skin condition characterized by inflammation and itching. At the molecular level, lebrikizumab works by targeting and inhibiting interleukin-13, a protein involved in the inflammatory process of the skin. It is classified pharmacologically as a monoclonal antibody.

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 may be accompanied by asthma or hay fever. The skin may become thickened, cracked, or scaly over time. Itching can be severe, leading to scratching and further skin damage. The condition is influenced by genetic and environmental factors, and it can significantly impact the quality of life due to discomfort and visible skin changes.