Clinical trial NCT06921759: A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Hand and Foot Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 206
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 corticosteroids (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 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 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline
timeFrame: Week 16
Secondary outcomes:
measure: 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
timeFrame: Week 16
measure: Percentage of Participants Who Are "Satisfied" or "Very Satisfied" on Atopic Hand Dermatitis Clearance Satisfaction (AHDCS)
timeFrame: Week 16
measure: Percent Change from Baseline in Hand and Foot Peak Pain NRS
timeFrame: Baseline, Week 16
measure: Percentage of Participants with HF-Peak Pruritus NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction (Improvement) from Baseline
timeFrame: Baseline, Week 4
measure: Percent Change from Baseline in Modified Total Lesion Symptom Scale (mTLSS) for Hand and Foot Lesions
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in Hand Eczema Severity Index (HECSI) Score for Participants with Hand Dermatitis
timeFrame: Baseline, Week 16
measure: Percentage of Participants with Hand Dermatitis Achieving HECSI-50 Score
timeFrame: Week 16
measure: Percentage of Participants with Hand Dermatitis Achieving HECSI-75 Score
timeFrame: Week 16
measure: Percentage of Participants with Hand Dermatitis Achieving HECSI-90 Score
timeFrame: Week 16
measure: Change from Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) for Participants with Hand Dermatitis
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida - Miami - Southwest 8th Street
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Hoboken
country: United States
facility: Care Access - Hoboken
state: New Jersey
city: Boardman
country: United States
facility: Optima Research - Boardman
state: Ohio
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia Y Dermatologia
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Respirar
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro de Investigaciones San Miguel
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CONEXA Investigacion Clinica S.A.
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden
state: Australian Capital Territory
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: Mitcham
country: Australia
facility: Institute for Skin, Health and Immunity
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: South Bunbury
country: Australia
facility: Brecken Health Bunbury
state: Western Australia
city: Red Deer
country: Canada
facility: CaRe Clinic
state: Alberta
city: Kelowna
country: Canada
facility: Interior Dermatology Centre - Probity - PPDS
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Chicoutimi
country: Canada
facility: INTERMED Groupe Sante
state: Quebec
city: Montréal
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Regina
country: Canada
facility: Private Practice - Dr. Rachel Asiniwasis
state: Saskatchewan
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Kawasaki-shi
country: Japan
facility: Kosugi Dermatology Clinic
state: Kanagawa
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Koto-ku
country: Japan
facility: Maruyama Dermatology Clinic
state: Tokyo
city: Ota
country: Japan
facility: Tanpopo Skin Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Tachikawa
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine
city: Saitama
country: Japan
facility: Pansy Skin Clinic
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Kwangju-Kwangyǒkshi
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyǒngsangnam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-Kwangyǒkshi
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Grupo Clínico CATEI S.C.
state: Jalisco
city: Zapopan
country: Mexico
facility: Instituto Dermatologico de Jalisco
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C.
state: Nuevo León
city: Mérida
country: Mexico
facility: Kohler & Milstein Research S.A. De C.V.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Zhu Bei City
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch
state: Hsinchu
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital
state: New Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: