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Lebrikizumab for adults and teens with moderate eczema and high itch

A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden

Phase 4 Interventional Eli Lilly and Company · NCT07006792

This trial tests whether lebrikizumab alone can reduce eczema severity and severe itch in adults and adolescents with moderate atopic dermatitis affecting about 10–25% of the body.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment200 (estimated)
Ages12 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsrituximab, methotrexate, lebrikizumab
Locations66 sites (Birmingham, Alabama and 65 other locations)
Trial IDNCT07006792 on ClinicalTrials.gov

What this trial studies

This phase 4, single-drug interventional trial gives lebrikizumab to eligible participants over a 24-week treatment period within an overall participation time of about 38 weeks. Eligible participants have chronic atopic dermatitis for at least one year, moderate disease affecting 10–25% body surface area, high itch (pruritus NRS ≥6), and elevated EASI and IGA scores despite topical therapy or when topical therapy is not appropriate. The study is sponsored by Eli Lilly and conducted at dermatology clinic sites in Alabama and Arizona. Safety and skin/itch outcomes will be tracked through scheduled clinic visits during and after the treatment phase.

Who should consider this trial

Good fit: Adults and adolescents (12+) weighing ≥40 kg with chronic moderate atopic dermatitis affecting 10–25% BSA, pruritus NRS ≥6, EASI ≥16, IGA ≥3, and prior inadequate response to or unsuitability for topical treatments are ideal candidates.

Not a fit: People with more extensive or milder disease outside the 10–25% BSA range, those with uncontrolled chronic conditions needing frequent oral steroids, or those meeting other medical exclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, lebrikizumab could offer a targeted biologic option that reduces skin inflammation and itch for people with moderate atopic dermatitis and a high itch burden.

How similar studies have performed: Other trials of lebrikizumab and similar IL-13–targeting biologics have shown positive results for atopic dermatitis, so this approach is supported by prior data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.
* Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.
* Have pruritus numeric rating scale (NRS) ≥6 at baseline.
* Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
* Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.
* Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.
* For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.

Exclusion Criteria:

* Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
* Have known liver cirrhosis and/or chronic hepatitis of any etiology.
* History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
* Are diagnosed with active endoparasitic infections or at high risk of these infections.
* Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment.
* Have presence of skin comorbidities that may interfere with study assessments.
* Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study.
* Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:

  * Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).
  * Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
  * Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
  * Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis).
* Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.
* Have had any prior treatment with a biologic therapy for AD.
* Have had treatment with any of the following agents within 4 weeks prior to the baseline visit:

  * systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,
  * azathioprine, methotrexate, and other immunosuppressants)
  * small molecules (for example, Janus kinase inhibitors \[topical or systemic\]), or
  * phototherapy and photochemotherapy for AD.
* Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.

Where this trial is running

Birmingham, Alabama and 65 other locations

+16 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 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.