A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
NCT ID: NCT06921759
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
206 participants
INTERVENTIONAL
2025-04-21
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lebrikizumab
Lebrikizumab administered subcutaneously (SC).
Lebrikizumab
Administered SC
Placebo
Placebo Administered SC.
Placebo
Administered SC
Interventions
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Lebrikizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Medical Dermatology Specialists
Phoenix, Arizona, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Encore Medical Research
Hollywood, Florida, United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
DeNova Research
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Revival Research Institute, LLC
Troy, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Care Access - Hoboken
Hoboken, New Jersey, United States
Optima Research - Boardman
Boardman, Ohio, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Complete Dermatology
Sugar Land, Texas, United States
CONEXA Investigacion Clinica S.A.
Buenos Aires, , Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, , Argentina
CIPREC
Buenos Aires, , Argentina
Instituto de Neumonologia Y Dermatologia
Buenos Aires, , Argentina
Psoriahue
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Parra Dermatología
Mendoza, , Argentina
Fundacion Estudios Clinicos
Rosario, , Argentina
INECO Neurociencias Oroño
Rosario, , Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, , Argentina
Centro de Investigaciones San Miguel
San Miguel, , Argentina
The Skin Centre
Benowa, , Australia
Skin Health Institute Inc.
Carlton, , Australia
Cornerstone Dermatology
Coorparoo, , Australia
Fremantle Dermatology
Fremantle, , Australia
St George Dermatology & Skin Cancer Centre
Kogarah, , Australia
Institute for Skin, Health and Immunity
Mitcham, , Australia
Paratus Clinical Research Woden
Phillip, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
SimcoDerm Medical and Surgical Dermatology Center
Barrie, , Canada
INTERMED Groupe Sante
Chicoutimi, , Canada
Interior Dermatology Centre - Probity - PPDS
Kelowna, , Canada
DermEffects
London, , Canada
Centre de Recherche Saint-Louis
Montreal, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
CaRe Clinic
Red Deer, , Canada
Private Practice - Dr. Rachel Asiniwasis
Regina, , Canada
FACET Dermatology
Toronto, , Canada
Wiseman Dermatology Research Inc.
Winnipeg, , Canada
Kosugi Dermatology Clinic
Kawasaki-shi, , Japan
Maruyama Dermatology Clinic
Kōtoku, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Tanpopo Skin Clinic
Ōta-ku, , Japan
Pansy Skin Clinic
Saitama, , Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Tachikawa Dermatology Clinic
Tachikawa, , Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad de México, , Mexico
Grupo Clínico CATEI S.C.
Guadalajara, , Mexico
RM Pharma Specialists
Mexico City, , Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, , Mexico
Eukarya Pharmasite S.C.
Monterrey, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Instituto Dermatologico de Jalisco
Zapopan, , Mexico
Korea University Ansan Hospital
Ansan-si, , South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, , South Korea
Pusan National University Yangsan Hospital
Busan, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Kyungpook National University Hospital
Junggu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, , Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
National Taiwan University Hospital - Hsinchu branch
Zhubei, , Taiwan
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Related Links
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Lilly Trials
Other Identifiers
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J2T-MC-KGCD
Identifier Type: OTHER
Identifier Source: secondary_id
27349
Identifier Type: -
Identifier Source: org_study_id
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