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
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CONEXA Investigacion Clinica S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Psoriahue Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Neumonologia y Dermatologia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigaciones Medicas Imoba Srl Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Parra Dermatología Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Fundacion Estudios Clinicos Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro de Investigaciones San Miguel Coordinator of this site? Confirm its status | San Miguel | Argentina | Unknown status |
| The Skin Centre Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| Skin Health Institute Inc. Coordinator of this site? Confirm its status | Carlton | Australia | Unknown status |
| Cornerstone Dermatology Coordinator of this site? Confirm its status | Coorparoo | Australia | Unknown status |
| Fremantle Dermatology Coordinator of this site? Confirm its status | Fremantle | Australia | Unknown status |
| St George Dermatology & Skin Cancer Centre Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Institute for Skin Health and Immunity Coordinator of this site? Confirm its status | Mitcham | Australia | Unknown status |
| Paratus Clinical Research, Woden Coordinator of this site? Confirm its status | Phillip | Australia | Unknown status |
| Veracity Clinical Research Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| SimcoDerm Medical and Surgical Dermatology Center Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| INTERMED Groupe Sante Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Interior Dermatology Centre - Probity - PPDS Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Dermeffects Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| CaRe Clinic Coordinator of this site? Confirm its status | Red Deer | Canada | Unknown status |
| Private Practice - Dr. Rachel Asiniwasis Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| FACET Dermatology Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Wiseman Dermatology Research Inc. Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Kosugi Dermatology Clinic Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Maruyama Dermatology Clinic Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Tanpopo Skin Clinic Coordinator of this site? Confirm its status | Ōta-ku | Japan | Unknown status |
| Pansy Skin Clinic Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Dermatology and Ophthalmology Kume Clinic Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Tachikawa Dermatology Clinic Coordinator of this site? Confirm its status | Tachikawa | Japan | Unknown status |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Unknown status |
| The Catholic University of Korea, Incheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bupyeong-gu | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Junggu | South Korea | Unknown status |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Cryptex Investigación Clínica S.A. de C.V. Coordinator of this site? Confirm its status | Cuauhtémoc, Ciudad de México | Mexico | Unknown status |
| Köhler & Milstein Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Eukarya Pharmasite S.C. Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| New Taipei Municipal TuCheng Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| National Taiwan University Hospital - Hsinchu branch Coordinator of this site? Confirm its status | Zhubei | Taiwan | Unknown status |
| Optima Research Boardman Coordinator of this site? Confirm its status | Boardman | United States | Unknown status |
| DeNova Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| First Oc Dermatology Research Inc Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Care Access - Hoboken Coordinator of this site? Confirm its status | Hoboken | United States | Unknown status |
| Encore Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Dermatology Research Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Research Associates of South Florida - Miami - Southwest 8th Street Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Southern Indiana Clinical trials Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Medisearch Clinical Trials Coordinator of this site? Confirm its status | Saint Joseph | United States | Unknown status |
| Progressive Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Complete Dermatology Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.