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Evaluating Lebrikizumab for Moderate-to-Severe Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Trial to Investigate the Efficacy and Safety of Lebrikizumab When Used With/Without Topical Corticosteroid Treatment in Participants With Moderate-To-Severe Atopic Dermatitis

Phase 3 Interventional Eli Lilly and Company · NCT06280716

This study is testing if a new medication called lebrikizumab can help people with moderate-to-severe atopic dermatitis feel better, either by itself or with a common skin cream, compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment430 (estimated)
Ages12 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionslebrikizumab
Locations46 sites (Wuhu, Anhui and 45 other locations)
Trial IDNCT06280716 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of lebrikizumab, both alone and in combination with topical corticosteroids, in patients suffering from moderate-to-severe atopic dermatitis. Participants will be monitored over a period of approximately 62 weeks to determine how well the treatment works compared to a placebo. The study will include individuals who have had chronic atopic dermatitis for at least one year and have not responded adequately to existing topical treatments. Various measures, including EASI and IGA scores, will be used to evaluate treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic moderate-to-severe atopic dermatitis who have not achieved adequate control with topical medications.

Not a fit: Patients with mild atopic dermatitis or those who have not tried topical treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with moderate-to-severe atopic dermatitis who have not responded to existing therapies.

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 chronic AD that has been present for ≥1 year before the screening period or have chronic eczema and meet the AAD criteria.
* Have moderate-to-severe AD, including all of the following at the baseline: EASI score ≥16, IGA score ≥3 (scale of 0 to 4), ≥10% BSA of AD involvement.
* Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

  1. Inability to achieve good disease control, defined as mild disease or better after use of at least a medium-potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, whichever is shorter. TCS may be used with or without TCIs and/or topical Janus kinase (JAK) inhibitors.
  2. Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, MTX, azathioprine, and MMF, will also be considered as surrogates for having inadequate response to topical therapy.
* Adolescents body weight must be ≥40 kg at baseline.
* Males may participate in this trial and comply with specific local government study requirements. Females of childbearing potential and females not of childbearing potential may participate in this trial.

Exclusion Criteria:

* Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
* Have a history of anaphylaxis or uncontrolled chronic disease that might require bursts of oral corticosteroids.
* Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.
* Have had Serious, Opportunistic, Chronic and Recurring infection within 3 months prior to the screening or develops any of these infections before the randomization.
* Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has not been treated with a complete course of appropriate therapy or such treatment is underway.
* Have a current infection with HBV, HCV, human immunodeficiency virus (HIV) infection.
* Have presence of skin comorbidities that may interfere with study assessments.
* Have a diagnosis or history of malignant disease within 5 years before screening, with the following exceptions:

  1. basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and
  2. cervical carcinoma in situ, with no evidence of recurrence within 5 years before screening visit.
* Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the study.

Where this trial is running

Wuhu, Anhui and 45 other locations

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 Dermatitis
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.