Home › Trials › NCT06921759

Investigating lebrikizumab for treating moderate-to-severe atopic hand and foot dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

Phase 3 Interventional Eli Lilly and Company · NCT06921759

This study tests if lebrikizumab can help adults and teens with moderate-to-severe hand and foot dermatitis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment206 (estimated)
Ages12 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionslebrikizumab, tralokinumab
Locations84 sites (Phoenix, Arizona and 83 other locations)
Trial IDNCT06921759 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of lebrikizumab compared to a placebo in adults and adolescents suffering from moderate-to-severe atopic hand and foot dermatitis. Participants will undergo a 32-week process that includes a 6-week screening phase, a 16-week treatment phase, and a follow-up visit 12 weeks after the last dose. The study aims to determine the impact of lebrikizumab on skin lesions and overall patient well-being.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents with a confirmed diagnosis of chronic atopic hand and/or foot dermatitis who have not responded adequately to topical corticosteroids.

Not a fit: Patients with mild atopic hand and foot dermatitis or those who have not previously used topical corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from atopic hand and foot dermatitis.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have an unequivocal diagnosis of chronic atopic hand and/or foot dermatitis at least 1 year prior to screening, regardless of the extent and severity of concomitant atopic dermatitis (AD) on other areas of the body. AD must be present in at least 2 of the 4 mentioned anatomical areas: left hand, right hand, left foot, or right foot at screening and baseline.
* Have a Hand Foot - Investigator Global Assessment (HF-IGA) score of 3 or 4 at the screening and baseline visits.
* Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4.
* Have a documented history by the investigator of inadequate response to topical corticosteroids (TCS) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of TCS is medically inadvisable (due to intolerance to treatment, hypersensitivity reactions, significant skin atrophy of hand and feet, and systemic effects, as assessed by the investigator or by the treating physician of the participant).
* For adolescent participants, body weight ≥40 kilograms (kg) at baseline.

Exclusion Criteria:

* Have a positive patch test reaction to 1 or more allergens (a score of 1+ or above according to the International Contact Dermatitis Research Group grading scale) before baseline AND which are deemed to be clinically relevant in the view of the investigator as the current cause of the hand and foot dermatitis.
* Have a documented diagnosis of allergic contact dermatitis (ACD) of hands and/or feet, and have a positive patch test reaction at screening, regardless of whether the history of current skin exposure to products containing this allergen (current relevance) is present.
* Have a documented or strong clinical suspicion of the diagnosis of protein contact dermatitis of hands and/or feet. These are the participants with occupational or nonoccupational contact with proteins such as food, latex, and so on, who have positive prick test results and present with lesions of contact urticaria or dermatitis on hands and feet.
* Have a documented exposure to irritants in the occupational or non-occupational (household/recreational) setting that is believed to be a predominant cause of the current hand and foot dermatitis as per the judgment of the investigator.
* Presence of skin comorbidities on hand and/or foot that may interfere with study assessments, such as (but not limited to) palmoplantar psoriasis, palmoplantar keratoderma, impetiginized eczema, lichen planus, pityriasis rubra pilaris, herpes simplex, erythema multiforme, tinea, or scabies.
* Have skin comorbidities that may interfere with study assessments
* Treatment with topical medications within 2 weeks before the baseline visit (except for the use of the participant's own emollients).
* Prior treatment with interleukin-13 (IL-13) inhibitors such as lebrikizumab or tralokinumab.
* Have received any live attenuated vaccine within less than 4 weeks of the baseline visit or intend to receive a live attenuated vaccine during the study, or within 4 weeks after receiving the last dose of study intervention.

Where this trial is running

Phoenix, Arizona 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 Hand and Foot 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.