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NCT06921759CompletedPhase 3

A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With 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

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
221 (actual)
First submitted
4 Apr 2025
Start date
21 Apr 2025
Primary completion date
13 May 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT06921759

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 221
  • From 21 Apr 2025 to the primary completion date, 13 May 2026
  • 76 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • 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 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.

Who the study is looking for

  • 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CONEXA Investigacion Clinica S.A.
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Buenos AiresArgentinaUnknown status
Psoriahue
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Buenos AiresArgentinaUnknown status
Instituto de Neumonologia y Dermatologia
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Buenos AiresArgentinaUnknown status
CIPREC
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Buenos AiresArgentinaUnknown status
Investigaciones Medicas Imoba Srl
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Buenos AiresArgentinaUnknown status
Fundacion Respirar
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Buenos AiresArgentinaUnknown status
Parra Dermatología
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MendozaArgentinaUnknown status
INECO Neurociencias Oroño
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RosarioArgentinaUnknown status
Fundacion Estudios Clinicos
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RosarioArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario
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RosarioArgentinaUnknown status
Centro de Investigaciones San Miguel
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San MiguelArgentinaUnknown status
The Skin Centre
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BenowaAustraliaUnknown status
Skin Health Institute Inc.
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CarltonAustraliaUnknown status
Cornerstone Dermatology
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CoorparooAustraliaUnknown status
Fremantle Dermatology
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FremantleAustraliaUnknown status
St George Dermatology & Skin Cancer Centre
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KogarahAustraliaUnknown status
Institute for Skin Health and Immunity
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MitchamAustraliaUnknown status
Paratus Clinical Research, Woden
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PhillipAustraliaUnknown status
Veracity Clinical Research
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WoolloongabbaAustraliaUnknown status
SimcoDerm Medical and Surgical Dermatology Center
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BarrieCanadaUnknown status
INTERMED Groupe Sante
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ChicoutimiCanadaUnknown status
Interior Dermatology Centre - Probity - PPDS
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KelownaCanadaUnknown status
Dermeffects
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LondonCanadaUnknown status
Centre de Recherche Saint-Louis
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MontrealCanadaUnknown status
Centre de Recherche Saint-Louis
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QuébecCanadaUnknown status
CaRe Clinic
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Red DeerCanadaUnknown status
Private Practice - Dr. Rachel Asiniwasis
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ReginaCanadaUnknown status
FACET Dermatology
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TorontoCanadaUnknown status
Wiseman Dermatology Research Inc.
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WinnipegCanadaUnknown status
Kosugi Dermatology Clinic
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Kawasaki-shiJapanUnknown status
Maruyama Dermatology Clinic
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KōtokuJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Tanpopo Skin Clinic
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Ōta-kuJapanUnknown status
Pansy Skin Clinic
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SaitamaJapanUnknown status
Dermatology and Ophthalmology Kume Clinic
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SakaiJapanUnknown status
Tokyo Medical University Hospital
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Shinjuku-kuJapanUnknown status
Tachikawa Dermatology Clinic
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TachikawaJapanUnknown status
Korea University Ansan Hospital
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Ansan-siSouth KoreaUnknown status
The Catholic University of Korea, Incheon St. Mary's Hospital
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Bupyeong-guSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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BusanSouth KoreaUnknown status
Chosun University Hospital
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GwangjuSouth KoreaUnknown status
Kyungpook National University Hospital
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JungguSouth KoreaUnknown status
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Konkuk University Medical Center
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoUnknown status
Cryptex Investigación Clínica S.A. de C.V.
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Cuauhtémoc, Ciudad de MéxicoMexicoUnknown status
Köhler & Milstein Research S.A. de C.V.
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MéridaMexicoUnknown status
Eukarya Pharmasite S.C.
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MonterreyMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Chang Gung Memorial Hospital at Kaohsiung
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Kaohsiung Niao Sung DistTaiwanUnknown status
New Taipei Municipal TuCheng Hospital
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New Taipei CityTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
National Taiwan University Hospital - Hsinchu branch
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ZhubeiTaiwanUnknown status
Optima Research Boardman
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BoardmanUnited StatesUnknown status
DeNova Research
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ChicagoUnited StatesUnknown status
First Oc Dermatology Research Inc
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Fountain ValleyUnited StatesUnknown status
Care Access - Hoboken
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HobokenUnited StatesUnknown status
Encore Medical Research
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HollywoodUnited StatesUnknown status
Dermatology Research Associates
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Los AngelesUnited StatesUnknown status
Research Associates of South Florida - Miami - Southwest 8th Street
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MiamiUnited StatesUnknown status
Southern Indiana Clinical trials
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New AlbanyUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Medisearch Clinical Trials
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Saint JosephUnited StatesUnknown status
Progressive Clinical Research
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San AntonioUnited StatesUnknown status
Texas Dermatology and Laser Specialists
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San AntonioUnited StatesUnknown status
Complete Dermatology
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Sugar LandUnited StatesUnknown status
Revival Research Institute, LLC
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TroyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.