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Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents 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 being done in children and teenagers ages 6 months to under 18 years who have Atopic Dermatitis, also called eczema, that is moderate to severe. The study uses lebrikizumab, a medicine given as an injection under the skin, and a placebo to match LY3650150. The purpose of the study is to learn more about the long-term safety of lebrikizumab in this age group.

Participants receive study treatment over a long period of time and are followed during the study to see how they do. Some participants may receive lebrikizumab, while others may receive the placebo to match LY3650150. The study is designed to gather information over time about how safe the treatment is and how well it works for this skin condition.

The research process

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

  1. Step 1

    <b>study treatment begins</b>

    After joining the study, you begin receiving lebrikizumab, which is given as a solution for injection in a pre-filled syringe.

    The study is a long-term extension study, so your treatment and follow-up continue over a long period while your safety and response are checked.

  2. Step 2

    <b>study treatment during the trial</b>

    You continue to receive lebrikizumab during the trial. the source data does not give a dose amount, how often it is given, or the exact length of treatment, so these details are not specified.

    The study is designed for participants with moderate-to-severe atopic dermatitis, also called eczema. the main purpose is to check the long-term safety of lebrikizumab.

  3. Step 3

    <b>monitoring during the trial</b>

    During the study, your treatment is monitored for adverse events, which means unwanted medical problems or side effects that happen during treatment.

    One main outcome of the study is whether participants stop study treatment because of adverse events.

  4. Step 4

    <b>end of the trial period</b>

    The trial continues until the planned study period ends. the estimated study period runs from 2023-12-01 to 2029-04-09.

    At the end of the study period, the course of treatment and safety assessment for the trial is completed.

Who can join the trial?

2 criteria

  • Must have received treatment in study J2T-MC-KGBI before joining this study.
  • Must have completed the study treatment in study J2T-MC-KGBI, meaning the treatment plan from that study was finished as required.

Who cannot join the trial?

2 criteria

  • Any participant who has had a serious adverse event from taking part in study J2T-MC-KGBI cannot join. A serious adverse event means a harmful medical problem that is severe, dangerous, or requires urgent medical care.
  • Any participant who has had an adverse event from taking part in study J2T-MC-KGBI cannot join. An adverse event means any unwanted medical problem or side effect that happened during the study.
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Investigated drugs

Lebrikizumab is the study medicine being tested in this trial. It is given as an injection under the skin and is used to help treat moderate to severe atopic dermatitis, also called eczema. The trial is looking at how safe it is to use over a long time in children and teenagers, and how well it helps control their skin symptoms.

What is already known about the treatment

  • Lebrikizumab

    Lebrikizumab is given as a solution for injection in a pre-filled syringe, usually under the skin. It is an antibody medicine that is still being studied and used in some countries for atopic dermatitis, also called eczema, especially when the disease is moderate to severe. It is a targeted anti-inflammatory medicine that blocks a signal called interleukin-13, which helps reduce skin inflammation, itching, and redness. It belongs to the class of monoclonal antibodies used for immune-related skin diseases.

  • Placebo to match LY3650150

    This is a placebo, so it does not contain an active medicine and is designed to look like the study drug. It is usually given in the same way as the real treatment so that the study can compare results fairly. A placebo has no direct therapeutic effect, but it helps researchers measure the true benefits and side effects of the active medicine. It is not a treatment for atopic dermatitis and does not belong to a pharmacological drug class.

Investigated diseases

Atopic Dermatitis - Atopic dermatitis, also called eczema, is a long-lasting inflammatory skin disease that causes dry, itchy, and irritated skin. It often begins in childhood and can come and go in flare-ups. The skin may become red, rough, and thickened over time because of repeated scratching and inflammation. In some people, symptoms improve with age, while in others the condition continues for many years.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501478-21-00Estimated enrolment265 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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