A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

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

  • Atopic Hand and Foot Dermatitis

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 medication(s) (topical corticosteroids (TCIs/TCS), topical PDE-4 inhibitors, or topical janus kinase (JAK) inhibitors) in the treatment of atopic hand foot dermatitis (AHFD) within 6 months of screening, or use of topical medications 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 on the hands and feet 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

Medical Dermatology Specialists
Phoenix 5308655, Arizona 5551752 85006
Contact:
602-354-5770

First OC Dermatology Research Inc
Fountain Valley 5350207, California 5332921 92708
Contact:
714-531-2966

Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045
Contact:
310-337-7171

Encore Medical Research
Hollywood 4158928, Florida 4155751 33024
Contact:
954-400-1725

Research Associates of South Florida - Miami - Southwest 8th Street
Miami 4164138, Florida 4155751 33134

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470
Contact:
352-629-5800

DeNova Research
Chicago 4887398, Illinois 4896861 60602

Dawes Fretzin Clinical Research Group, LLC
Indianapolis 4259418, Indiana 4921868 46250
Contact:
317-516-5030

Southern Indiana Clinical Trials
New Albany 4262045, Indiana 4921868 47150
Contact:
502-373-8133

Revival Research Institute, LLC
Troy 5012639, Michigan 5001836 48084
Contact:
248-590-0298

MediSearch Clinical Trials
Saint Joseph 4407010, Missouri 4398678 64506
Contact:
816-364-1515

Care Access - Hoboken
Hoboken 5099133, New Jersey 5101760 07030
Contact:
551-278-8680

Optima Research - Boardman
Boardman 5147784, Ohio 5165418 44512
Contact:
330-422-3234

Progressive Clinical Research
San Antonio 4726206, Texas 4736286 78213
Contact:
210-614-5557

Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218
Contact:
210-852-2779

Complete Dermatology
Sugar Land 4734825, Texas 4736286 77479

More Details

NCT ID
NCT06921759
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

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