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

Last updated: July 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Rash

Treatment

Placebo

Lebrikizumab

Clinical Study ID

NCT06921759
27349
J2T-MC-KGCD
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 concomitantatopic dermatitis (AD) on other areas of the body. AD must be present in at least 2of the 4 mentioned anatomical areas: left hand, right hand, left foot, or right footat screening and baseline.

  • Have a Hand Foot - Investigator Global Assessment (HF-IGA) score of 3 or 4 at thescreening 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 topicalcorticosteroids (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 totreatment, hypersensitivity reactions, significant skin atrophy of hand and feet,and systemic effects, as assessed by the investigator or by the treating physicianof the participant).

  • For adolescent participants, body weight ≥40 kilograms (kg) at baseline.

Exclusion

Exclusion Criteria:

  • Have a positive patch test reaction to 1 or more allergens (a score of 1+ or aboveaccording to the International Contact Dermatitis Research Group grading scale)before baseline AND which are deemed to be clinically relevant in the view of theinvestigator as the current cause of the hand and foot dermatitis.

  • Have a documented diagnosis of allergic contact dermatitis (ACD) of hands and/orfeet, and have a positive patch test reaction at screening, regardless of whetherthe history of current skin exposure to products containing this allergen (currentrelevance) is present.

  • Have a documented or strong clinical suspicion of the diagnosis of protein contactdermatitis of hands and/or feet. These are the participants with occupational ornonoccupational contact with proteins such as food, latex, and so on, who havepositive prick test results and present with lesions of contact urticaria ordermatitis 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 thecurrent hand and foot dermatitis as per the judgment of the investigator.

  • Presence of skin comorbidities on hand and/or foot that may interfere with studyassessments, such as (but not limited to) palmoplantar psoriasis, palmoplantarkeratoderma, impetiginized eczema, lichen planus, pityriasis rubra pilaris, herpessimplex, 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 (exceptfor the use of the participant's own emollients).

  • Prior treatment with interleukin-13 (IL-13) inhibitors such as lebrikizumab ortralokinumab.

  • Have received any live attenuated vaccine within less than 4 weeks of the baselinevisit or intend to receive a live attenuated vaccine during the study, or within 4weeks after receiving the last dose of study intervention.

Study Design

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 21, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425BEA
    Argentina

    Site Not Available

  • Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
    Argentina

    Site Not Available

  • Fundación Respirar

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
    Argentina

    Site Not Available

  • Centro de Investigaciones San Miguel

    San Miguel, Buenos Aires 1663
    Argentina

    Site Not Available

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1056ABH
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe S2000CVD
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, C1061AAS
    Argentina

    Site Not Available

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012
    Argentina

    Site Not Available

  • Parra Dermatología

    Mendoza, 5500
    Argentina

    Site Not Available

  • Paratus Clinical Research Woden

    Phillip, Australian Capital Territory 2606
    Australia

    Active - Recruiting

  • Emeritus Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • St George Dermatology & Skin Cancer Centre

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • The Skin Centre

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Cornerstone Dermatology

    Coorparoo, Queensland 4151
    Australia

    Active - Recruiting

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Skin Health Institute Inc.

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Institute for Skin, Health and Immunity

    Mitcham, Victoria 3132
    Australia

    Site Not Available

  • Fremantle Dermatology

    Fremantle, Western Australia 6160
    Australia

    Active - Recruiting

  • Brecken Health Bunbury

    South Bunbury, Western Australia 6230
    Australia

    Site Not Available

  • CaRe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Active - Recruiting

  • Interior Dermatology Centre - Probity - PPDS

    Kelowna, British Columbia V1W 4V5
    Canada

    Active - Recruiting

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Active - Recruiting

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • DermEffects

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • FACET Dermatology

    Toronto, Ontario M4E 1R7
    Canada

    Active - Recruiting

  • INTERMED Groupe Sante

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Montréal, Quebec H1Y 3L1
    Canada

    Active - Recruiting

  • Private Practice - Dr. Rachel Asiniwasis

    Regina, Saskatchewan S4V 1R9
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Active - Recruiting

  • Kosugi Dermatology Clinic

    Kawasaki-shi, Kanagawa 211-0063
    Japan

    Active - Recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Active - Recruiting

  • Maruyama Dermatology Clinic

    Koto-ku, Tokyo 136-0074
    Japan

    Active - Recruiting

  • Tanpopo Skin Clinic

    Ota, Tokyo 143-0023
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Tachikawa Dermatology Clinic

    Tachikawa, Tokyo 190-0023
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Pansy Skin Clinic

    Saitama, 330-0064
    Japan

    Active - Recruiting

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Bupyeong-gu, Incheon-gwangyeoksi [Incheon] 21431
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju, Kwangju-Kwangyǒkshi 61453
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do 15355
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, Kyǒnggi-do 16499
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Busan, Kyǒngsangnam-do 50612
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 05505
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 05030
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [Seoul] 05278
    Korea, Republic of

    Site Not Available

  • National Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 01812
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    Korea, Republic of

    Site Not Available

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Jung-gu, Taegu-Kwangyǒkshi 41944
    Korea, Republic of

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • RM Pharma Specialists

    Mexico City, Distrito Federal 03100
    Mexico

    Site Not Available

  • Grupo Clínico CATEI S.C.

    Guadalajara, Jalisco 44638
    Mexico

    Site Not Available

  • Instituto Dermatologico de Jalisco

    Zapopan, Jalisco 45190
    Mexico

    Site Not Available

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo León 64718
    Mexico

    Site Not Available

  • Kohler & Milstein Research S.A. De C.V.

    Mérida, Yucatán 97070
    Mexico

    Site Not Available

  • Scientia Investigacion Clinica S.C.

    Chihuahua, 31203
    Mexico

    Site Not Available

  • Arké SMO S.A de C.V

    Veracruz, 91900
    Mexico

    Site Not Available

  • National Taiwan University Hospital - Hsinchu branch

    Zhu Bei City, Hsinchu 302
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung 83301
    Taiwan

    Site Not Available

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, New Taipei 236
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei City, Taipei 114
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • First OC Dermatology Research Inc

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Associates of South Florida - Miami - Southwest 8th Street

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Care Access - Hoboken

    Hoboken, New Jersey 07030
    United States

    Active - Recruiting

  • Optima Research - Boardman

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

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