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NCT06921759

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2025-04-21

Completion Date

2026-09

Last Updated

2026-02-27

Healthy Volunteers

Conditions

Atopic Hand and Foot Dermatitis

Interventions

DRUG

Lebrikizumab

Administered SC

DRUG

Placebo

Administered SC

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.

Locations (79)

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (79)