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Purpose

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis. This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lebrikizumab 		Lebrikizumab administered subcutaneously (SC).
  • Drug: Lebrikizumab
    Administered SC
    Other names:
    • LY3650150
Placebo Comparator
Placebo 		Placebo Administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Dermatology Research Associates
Los Angeles, California 90045
Contact:
310-337-7171

Encore Medical Research
Hollywood, Florida 33024
Contact:
954-400-1725

Renstar Medical Research
Ocala, Florida 34470
Contact:
352-629-5800

DeNova Research
Chicago, Illinois 60602

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Contact:
317-516-5030

Southern Indiana Clinical Trials
New Albany, Indiana 47150
Contact:
502-373-8133

MediSearch Clinical Trials
Saint Joseph, Missouri 64506
Contact:
816-364-1515

Care Access - Hoboken
Hoboken, New Jersey 07030
Contact:
551-278-8680

Optima Research - Boardman
Boardman, Ohio 44512
Contact:
330-422-3234

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
Contact:
210-852-2779

More Details

NCT ID
NCT06921759
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
3176154559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center