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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Hand and Foot Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Buenos Aires, Argentina, C1425BEA
    • Instituto de Neumonologia Y Dermatologia
  • Buenos Aires, Argentina, 1012
    • Conexa Investigacion Clinica S.A.
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Buenos Aires, Argentina, C1056ABH
    • Investigaciones Medicas IMOBA SRL
  • Buenos Aires, Argentina, C1425DKG
    • Psoriahue
  • Mendoza, Argentina, 5500
    • Parra Dermatología
  • Rosario, Argentina, 2000
    • INECO Neurociencias Oroño
  • Rosario, Argentina, S2000CVD
    • Instituto de Investigaciones Clinicas Rosario
  • Rosario, Argentina, 2000
    • Fundacion Estudios Clinicos
  • San Miguel, Argentina, 1663
    • Centro de Investigaciones San Miguel
• Australia
  • Benowa, Australia, 4217
    • The Skin Centre
  • Carlton, Australia, 3053
    • Skin Health Institute Inc.
  • Coorparoo, Australia, 4151
    • Cornerstone Dermatology
  • Fremantle, Australia, 6160
    • Fremantle Dermatology
  • Kogarah, Australia, 2217
    • St George Dermatology & Skin Cancer Centre
  • Mitcham, Australia, 3132
    • Institute for Skin, Health and Immunity
  • Phillip, Australia, 2606
    • Paratus Clinical Research Woden
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
• Canada
  • Barrie, Canada, L4M 7G1
    • SimcoDerm Medical and Surgical Dermatology Center
  • Chicoutimi, Canada, G7H 7Y8
    • INTERMED Groupe Sante
  • Kelowna, Canada, V1W 4V5
    • Interior Dermatology Centre - Probity - PPDS
  • London, Canada, N6H 5L5
    • Dermeffects
  • Montreal, Canada, H1Y 3L1
    • Centre de Recherche Saint-Louis
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Red Deer, Canada, T4P 1K4
    • CaRe Clinic
  • Regina, Canada, S4V 1R9
    • Private Practice - Dr. Rachel Asiniwasis
  • Toronto, Canada, M4E 1R7
    • FACET Dermatology
  • Winnipeg, Canada, R3M 3Z4
    • Wiseman Dermatology Research Inc.
• Japan
  • Kawasaki-shi, Japan, 211-0063
    • Kosugi Dermatology Clinic
  • Kyoto, Japan, 602-8566
    • University Hospital,Kyoto Prefectural University of Medicine
  • Kōtoku, Japan, 136-0074
    • Maruyama Dermatology Clinic
  • Saitama, Japan, 330-0064
    • Pansy Skin Clinic
  • Sakai, Japan, 593-8324
    • Dermatology and Ophthalmology Kume Clinic
  • Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tachikawa, Japan, 190-0023
    • Tachikawa Dermatology Clinic
  • Ōta-ku, Japan, 143-0023
    • Tanpopo Skin Clinic
• Mexico
  • Chihuahua City, Mexico, 31203
    • Scientia Investigacion Clinica S.C.
  • Cuauhtémoc, Ciudad de México, Mexico, 06100
    • Cryptex Investigación Clínica S.A. de C.V.
  • Guadalajara, Mexico, 44638
    • Grupo Clínico CATEI S.C.
  • Mexico City, Mexico, 03100
    • RM Pharma Specialists
  • Monterrey, Mexico, 64718
    • Eukarya Pharmasite S.C.
  • Mérida, Mexico, 97070
    • Köhler & Milstein Research S.A. de C.V.
  • Veracruz, Mexico, 91900
    • Arké SMO S.A de C.V
  • Zapopan, Mexico, 45190
    • Instituto Dermatologico de Jalisco
• South Korea
  • Ansan-si, South Korea, 15355
    • Korea University Ansan Hospital
  • Bupyeong-gu, South Korea, 21431
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Busan, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Gwangju, South Korea, 61453
    • Chosun university hospital
  • Junggu, South Korea, 41944
    • Kyungpook National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, South Korea, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Taiwan
  • Kaohsiung Niao Sung Dist, Taiwan, 83301
    • Chang Gung Memorial Hospital at Kaohsiung
  • New Taipei City, Taiwan, 236
    • New Taipei Municipal TuCheng Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Zhubei, Taiwan, 302
    • National Taiwan University Hospital - Hsinchu branch
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research Inc
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
  • Florida
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research
    • Miami, Florida, United States, 33134
      • Research Associates of South Florida - Miami - Southwest 8th Street
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60602
      • DeNova Research
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Southern Indiana Clinical trials
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Care Access - Hoboken
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research - Boardman
  • Texas
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Complete Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab; Lebrikizumab administered subcutaneously (SC).	Drug: Lebrikizumab; Administered SC; Other Names: LY3650150
Placebo Comparator: Placebo; Placebo Administered SC.	Drug: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline	The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline	The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).	Week 16
Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS)	This single-item question assesses participants' satisfaction with hand clearance at the current time. The response options are reported as the percentage of participants who selected 1 of the following: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, or Very Dissatisfied.	Week 16
Percent Change from Baseline in Hand and Foot Peak Pain NRS	The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).	Baseline, Week 16
Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline	The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).	Baseline, Week 4
Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions	The mTLSS is an investigator-reported scale that combines the evaluation of lesion severity of hand eczema (HE) (erythema, edema, desquamation, fissures, hyperkeratosis or lichenification, and vesicles) with the intensity of pruritus or pain to assess the severity of symptoms. This composite score assigns 0 (mild) to 3 (severe) to each component, giving a maximum disease severity of 21. A separate score is assigned for hands and feet.	Baseline, Week 16
Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis	The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.	Baseline, Week 16
Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score	The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.	Week 16
Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score	The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.	Week 16
Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score	The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.	Week 16
Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis	The QOLHEQ consists of 30 items that can be summarized according to 4 domains of HRQoL: impairments over the last 7 days because of (1) symptoms, (2) emotions, (3) limitations in functioning, or (4) treatment and prevention. The total QOLHEQ score ranges between 0 and 117, with higher scores indicative of a poor HE-specific HRQoL.	Baseline, Week 16
Percentage of Participants with a HF-Peak Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline	The HF-peak pruritus NRS scale is an assessment tool used daily by the participants to rate their worst hand and feet itch intensity on a scale ranging from 0 (no itch) to 10 (worst imaginable itch).	Week 2
Percentage of Participants with a HF-Peak Pain NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline	The HF-peak pain NRS Scale is an assessment tool used daily by the participants to report the intensity of pain. Participants select the number between 0 and 10 that best fits their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).	Week 16
Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline	The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.	Week 4
Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline	The HF-IGA is an assessment scale used to determine the severity of hand and foot atopic dermatitis (AD) and clinical response to treatment on a 5-point scale, 0 (clear) to 4 (severe). Higher scores indicate more disease severity.	Week 8

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• Lilly Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Substandard Drugs; Pharmaceutical Preparations; lebrikizumab
• Other Study ID Numbers: 27349; J2T-MC-KGCD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No