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Evaluating Lebrikizumab for Children with Moderate-to-Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Phase 3 Interventional Eli Lilly and Company · NCT05559359

This study is testing if a new medication called lebrikizumab can help children aged 6 months to under 18 years with moderate-to-severe eczema feel better and improve their skin.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages6 Months to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsDupilumab, lebrikizumab
Locations84 sites (Birmingham, Alabama and 83 other locations)
Trial IDNCT05559359 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness, safety, and absorption of lebrikizumab in pediatric participants aged 6 months to less than 18 years who have moderate-to-severe atopic dermatitis. Participants will receive either lebrikizumab, a placebo, or topical corticosteroids as part of the treatment regimen. The study will measure the impact of the treatment on the severity of atopic dermatitis using established scoring systems. The goal is to provide insights into how well this medication works in a younger population.

Who should consider this trial

Good fit: Ideal candidates include children aged 6 months to less than 18 years with a confirmed diagnosis of moderate-to-severe atopic dermatitis.

Not a fit: Patients who have recently participated in other clinical studies or have used specific prior treatments like Dupilumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of atopic dermatitis in children, leading to better skin health and quality of life.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for atopic dermatitis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,

  * 12 months if participants are ≥6 years of age
  * 6 months if participants are 2 to \<6 years of age
  * 3 months if participants are 6 months to \<2 years of age.
* Have an EASI score ≥16 at the screening and baseline
* Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
* Have ≥10% BSA of AD involvement at the screening and baseline.

Exclusion Criteria:

* Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Treatment with the following prior to the baseline:
* An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
* Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
* Treatment with a topical investigational drug within 2 weeks prior to the baseline.
* Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Where this trial is running

Birmingham, Alabama and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisEczema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.