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

NCT06921759 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: 27349J2T-MC-KGCD
• Study Type: interventional
• Target: 206
• Locations: 8 countries
• Sites: 79

Brief 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.

Conditions

Atopic Hand and Foot Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  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

  Week 2

• Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

  Baseline, Week 4

• Percentage of Participants with a HF-Peak Pain NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline

  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

  Week 4

Study Arms (2)

Lebrikizumab

EXPERIMENTAL

Lebrikizumab administered subcutaneously (SC).

Drug: Lebrikizumab

Placebo

PLACEBO COMPARATOR

Placebo Administered SC.

Drug: Placebo

Interventions

Lebrikizumab DRUG

Administered SC

Also known as: LY3650150

Lebrikizumab

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (79)

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

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

Miami, Florida, 33134, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

DeNova Research

Chicago, Illinois, 60602, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Care Access - Hoboken

Hoboken, New Jersey, 07030, United States

Location

Optima Research - Boardman

Boardman, Ohio, 44512, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Complete Dermatology

Sugar Land, Texas, 77479, United States

Location

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012, Argentina

Location

Investigaciones Medicas Imoba Srl

Buenos Aires, C1056ABH, Argentina

Location

CIPREC

Buenos Aires, C1061AAS, Argentina

Location

Instituto de Neumonologia Y Dermatologia

Buenos Aires, C1425BEA, Argentina

Location

Psoriahue

Buenos Aires, C1425DKG, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Parra Dermatología

Mendoza, 5500, Argentina

Location

Fundacion Estudios Clinicos

Rosario, 2000, Argentina

Location

INECO Neurociencias Oroño

Rosario, 2000, Argentina

Location

Instituto de Investigaciones Clinicas Rosario

Rosario, S2000CVD, Argentina

Location

Centro de Investigaciones San Miguel

San Miguel, 1663, Argentina

Location

The Skin Centre

Benowa, 4217, Australia

Location

Skin Health Institute Inc.

Carlton, 3053, Australia

Location

Cornerstone Dermatology

Coorparoo, 4151, Australia

Location

Fremantle Dermatology

Fremantle, 6160, Australia

Location

St George Dermatology & Skin Cancer Centre

Kogarah, 2217, Australia

Location

Institute for Skin, Health and Immunity

Mitcham, 3132, Australia

Location

Paratus Clinical Research Woden

Phillip, 2606, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, L4M 7G1, Canada

Location

INTERMED Groupe Sante

Chicoutimi, G7H 7Y8, Canada

Location

Interior Dermatology Centre - Probity - PPDS

Kelowna, V1W 4V5, Canada

Location

DermEffects

London, N6H 5L5, Canada

Location

Centre de Recherche Saint-Louis

Montreal, H1Y 3L1, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada

Location

CaRe Clinic

Red Deer, T4P 1K4, Canada

Location

Private Practice - Dr. Rachel Asiniwasis

Regina, S4V 1R9, Canada

Location

FACET Dermatology

Toronto, M4E 1R7, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, R3M 3Z4, Canada

Location

Kosugi Dermatology Clinic

Kawasaki-shi, 211-0063, Japan

Location

Maruyama Dermatology Clinic

Kōtoku, 136-0074, Japan

Location

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Tanpopo Skin Clinic

Ōta-ku, 143-0023, Japan

Location

Pansy Skin Clinic

Saitama, 330-0064, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, 593-8324, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023, Japan

Location

Tachikawa Dermatology Clinic

Tachikawa, 190-0023, Japan

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31203, Mexico

Location

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

Cuauhtémoc, Ciudad de México, 06100, Mexico

Location

Grupo Clínico CATEI S.C.

Guadalajara, 44638, Mexico

Location

RM Pharma Specialists

Mexico City, 03100, Mexico

Location

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

Mérida, 97070, Mexico

Location

Eukarya Pharmasite S.C.

Monterrey, 64718, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91900, Mexico

Location

Instituto Dermatologico de Jalisco

Zapopan, 45190, Mexico

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

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

Bupyeong-gu, 21431, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Kyungpook National University Hospital

Junggu, 41944, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

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

Seoul, 06591, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, 83301, Taiwan

Location

New Taipei Municipal TuCheng Hospital

New Taipei City, 236, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch

Zhubei, 302, Taiwan

Location

Related Links

• Lilly Trials

MeSH Terms

Interventions

lebrikizumab

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 10, 2025
• Study Start: April 21, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AU (8); ME (8); KR (12); TW (8); US (14); CA (10); JP (8); AR (11)