Phase
Condition
Allergy
Eczema (Atopic Dermatitis - Pediatric)
Rash
Treatment
Placebo
Lebrikizumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
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
Connect with a study center
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425BEA
ArgentinaSite Not Available
Psoriahue
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
ArgentinaSite Not Available
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
ArgentinaSite Not Available
Centro de Investigaciones San Miguel
San Miguel, Buenos Aires 1663
ArgentinaSite Not Available
Investigaciones Medicas Imoba Srl
Buenos Aires, Ciudad Autónoma De Buenos Aires C1056ABH
ArgentinaSite Not Available
Fundacion Estudios Clinicos
Rosario, Santa Fe 2000
ArgentinaSite Not Available
INECO Neurociencias Oroño
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe S2000CVD
ArgentinaSite Not Available
CIPREC
Buenos Aires, C1061AAS
ArgentinaSite Not Available
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012
ArgentinaSite Not Available
Parra Dermatología
Mendoza, 5500
ArgentinaSite Not Available
Paratus Clinical Research Woden
Phillip, Australian Capital Territory 2606
AustraliaActive - Recruiting
Emeritus Research
Botany, New South Wales 2019
AustraliaSite Not Available
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
The Skin Centre
Benowa, Queensland 4217
AustraliaActive - Recruiting
Cornerstone Dermatology
Coorparoo, Queensland 4151
AustraliaActive - Recruiting
Veracity Clinical Research
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Emeritus Research
Camberwell, Victoria 3124
AustraliaSite Not Available
Skin Health Institute Inc.
Carlton, Victoria 3053
AustraliaActive - Recruiting
Institute for Skin, Health and Immunity
Mitcham, Victoria 3132
AustraliaSite Not Available
Fremantle Dermatology
Fremantle, Western Australia 6160
AustraliaActive - Recruiting
Brecken Health Bunbury
South Bunbury, Western Australia 6230
AustraliaSite Not Available
CaRe Clinic
Red Deer, Alberta T4P 1K4
CanadaActive - Recruiting
Interior Dermatology Centre - Probity - PPDS
Kelowna, British Columbia V1W 4V5
CanadaActive - Recruiting
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaActive - Recruiting
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
DermEffects
London, Ontario N6H 5L5
CanadaActive - Recruiting
FACET Dermatology
Toronto, Ontario M4E 1R7
CanadaActive - Recruiting
INTERMED Groupe Sante
Chicoutimi, Quebec G7H 7Y8
CanadaActive - Recruiting
Centre de Recherche Saint-Louis
Montréal, Quebec H1Y 3L1
CanadaActive - Recruiting
Private Practice - Dr. Rachel Asiniwasis
Regina, Saskatchewan S4V 1R9
CanadaActive - Recruiting
Centre de Recherche Saint-Louis
Quebec, G1W 4R4
CanadaActive - Recruiting
Kosugi Dermatology Clinic
Kawasaki-shi, Kanagawa 211-0063
JapanActive - Recruiting
Dermatology and Ophthalmology Kume Clinic
Sakai City, Osaka 593-8324
JapanActive - Recruiting
Maruyama Dermatology Clinic
Koto-ku, Tokyo 136-0074
JapanActive - Recruiting
Tanpopo Skin Clinic
Ota, Tokyo 143-0023
JapanActive - Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo 160-0023
JapanSite Not Available
Tachikawa Dermatology Clinic
Tachikawa, Tokyo 190-0023
JapanActive - Recruiting
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566
JapanSite Not Available
Pansy Skin Clinic
Saitama, 330-0064
JapanActive - Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, Incheon-gwangyeoksi [Incheon] 21431
Korea, Republic ofSite Not Available
Chosun University Hospital
Gwangju, Kwangju-Kwangyǒkshi 61453
Korea, Republic ofSite Not Available
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do 15355
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, Kyǒnggi-do 16499
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Busan, Kyǒngsangnam-do 50612
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 05505
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 05030
Korea, Republic ofSite Not Available
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul] 05278
Korea, Republic ofSite Not Available
National Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 01812
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul] 03722
Korea, Republic ofSite Not Available
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 06591
Korea, Republic ofSite Not Available
Kyungpook National University Hospital
Jung-gu, Taegu-Kwangyǒkshi 41944
Korea, Republic ofSite Not Available
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad De México, Distrito Federal 06100
MexicoSite Not Available
RM Pharma Specialists
Mexico City, Distrito Federal 03100
MexicoSite Not Available
Grupo Clínico CATEI S.C.
Guadalajara, Jalisco 44638
MexicoSite Not Available
Instituto Dermatologico de Jalisco
Zapopan, Jalisco 45190
MexicoSite Not Available
Eukarya Pharmasite S.C.
Monterrey, Nuevo León 64718
MexicoSite Not Available
Kohler & Milstein Research S.A. De C.V.
Mérida, Yucatán 97070
MexicoSite Not Available
Scientia Investigacion Clinica S.C.
Chihuahua, 31203
MexicoSite Not Available
Arké SMO S.A de C.V
Veracruz, 91900
MexicoSite Not Available
National Taiwan University Hospital - Hsinchu branch
Zhu Bei City, Hsinchu 302
TaiwanSite Not Available
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung 83301
TaiwanSite Not Available
New Taipei Municipal TuCheng Hospital
New Taipei City, New Taipei 236
TaiwanSite Not Available
Tri-Service General Hospital
Taipei City, Taipei 114
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanSite Not Available
Medical Dermatology Specialists
Phoenix, Arizona 85006
United StatesActive - Recruiting
First OC Dermatology Research Inc
Fountain Valley, California 92708
United StatesActive - Recruiting
Dermatology Research Associates
Los Angeles, California 90045
United StatesActive - Recruiting
Encore Medical Research
Hollywood, Florida 33024
United StatesActive - Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida 33134
United StatesActive - Recruiting
Renstar Medical Research
Ocala, Florida 34470
United StatesActive - Recruiting
DeNova Research
Chicago, Illinois 60602
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Southern Indiana Clinical Trials
New Albany, Indiana 47150
United StatesActive - Recruiting
Revival Research Institute, LLC
Troy, Michigan 48084
United StatesActive - Recruiting
MediSearch Clinical Trials
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
Care Access - Hoboken
Hoboken, New Jersey 07030
United StatesActive - Recruiting
Optima Research - Boardman
Boardman, Ohio 44512
United StatesActive - Recruiting
Progressive Clinical Research
San Antonio, Texas 78213
United StatesActive - Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesActive - Recruiting
Complete Dermatology
Sugar Land, Texas 77479
United StatesActive - Recruiting
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