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

Fast replyInvestigationalNo 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 long-term safety and effectiveness of a treatment called Lebrikizumab for individuals with Atopic Dermatitis, which is a condition that causes the skin to become red, itchy, and inflamed. The study involves adults and adolescents who have moderate-to-severe forms of this skin condition. Lebrikizumab is a type of medication known as a monoclonal antibody, which is given as a solution for injection under the skin. The purpose of the study is to observe how well patients tolerate this treatment over a period of two years.

Participants in the study will receive Lebrikizumab every four weeks. The study will monitor any side effects that may occur and how often patients need to stop the treatment due to these side effects. The study will also look at improvements in the severity of the skin condition, such as reductions in redness, itching, and the overall area of skin affected. The study aims to provide valuable information on the long-term use of Lebrikizumab for managing Atopic Dermatitis.

Throughout the study, participants will have regular visits to assess their skin condition and overall health. The study will track changes in the skin's appearance and the level of discomfort experienced by participants. This information will help determine the effectiveness of Lebrikizumab in providing relief from the symptoms of Atopic Dermatitis over an extended period. The study is designed to ensure that participants receive the best possible care while contributing to a better understanding of this treatment option.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written consent. This means you agree to participate and understand the purpose and risks involved.

    You will need to confirm that you have completed treatment with lebrikizumab in a previous study and attended the last assessment visit.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status and ensure you meet the study requirements.

    This assessment will include a review of your medical history and a physical examination.

  3. Step 3

    Medication administration

    You will receive lebrikizumab, which is a solution for injection. The medication will be administered under the skin, a method known as subcutaneous use.

    The dosage is 250 mg every four weeks (Q4W). This will continue for the duration of the study, which is up to two years.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your response to the medication and any side effects.

    During these visits, various assessments will be conducted, including skin evaluations and questionnaires about your symptoms and quality of life.

  5. Step 5

    End of study

    At the end of the study, a final assessment will be conducted to evaluate the long-term effects of the treatment.

    You will be asked to provide feedback on your experience and any changes in your condition.

Who can join the trial?

11 criteria

  • Patients who have completed treatment with lebrikizumab in a previous study called ADjoin and attended their last assessment visit at Week 100 in that study.
  • For Women of Childbearing Potential (WOCBP): Must agree to either remain abstinent (avoid heterosexual intercourse) or use a highly effective birth control method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab.
    • Highly effective birth control methods include:
      • Combined hormonal contraception (oral, intravaginal, transdermal) that prevents ovulation.
      • Progestogen-only hormonal contraception (oral, injectable, implantable) that prevents ovulation.
      • Intrauterine device (IUD).
      • Intrauterine hormone-releasing system.
      • Bilateral tubal occlusion or ligation (surgical procedures to block or tie the fallopian tubes).
      • Partner with a vasectomy (surgical procedure for male sterilization).
      • Sexual abstinence, if it means avoiding heterosexual intercourse during the entire risk period associated with the study treatments.
      • Note: Periodic abstinence methods (like calendar or ovulation methods) and withdrawal are not acceptable.
      • Ability to understand the purpose and risks of the trial, willingness and ability to follow the study rules, and provide written informed consent or assent according to guidelines.
      • Capable of giving signed informed consent or assent, which includes agreeing to the requirements and restrictions listed in the informed consent form and the study protocol.

Who cannot join the trial?

10 criteria

  • Patients who do not have Atopic Dermatitis cannot participate. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the age range specified for the study cannot participate. The study includes adults and adolescents.
  • Patients who have certain other medical conditions that might interfere with the study cannot participate. These conditions will be assessed by the study team.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had a recent infection or are currently experiencing an infection cannot participate.
  • Patients who have a history of severe allergic reactions to medications cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have used certain medications recently that might interfere with the study cannot participate. The study team will provide details on which medications are not allowed.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study cannot participate.
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Investigated drugs

Lebrikizumab is a medication being studied for its potential to help people with moderate-to-severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication works by targeting a specific protein in the body that is involved in causing inflammation. By blocking this protein, lebrikizumab may help reduce the symptoms of atopic dermatitis, such as itching and skin irritation. The study aims to see how safe and effective lebrikizumab is when used over a long period, specifically two years, to ensure it can be a reliable treatment option for patients.

What is already known about the treatment

Lebrikizumab – Lebrikizumab is administered as an injection under the skin, typically given once every four weeks. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating moderate-to-severe atopic dermatitis, a chronic skin condition characterized by itchy and inflamed skin. The medication works by targeting and blocking a specific protein in the body called interleukin-13 (IL-13), which plays a key role in the inflammation process associated with atopic dermatitis. Lebrikizumab is classified as a monoclonal antibody, a type of drug designed to specifically target and neutralize certain proteins in the body.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin's barrier function is compromised, leading to increased sensitivity and susceptibility to infections. Over time, repeated scratching and inflammation can cause the skin to thicken and become leathery. Environmental factors, allergens, and stress can trigger or exacerbate symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502575-30-00Protocol codeM-17923-32Estimated enrolment202 patientsSponsorAlmirall S.A.

sourced from the EU Clinical Trials Register and site verification

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