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A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Sponsor: Eli Lilly and Company
Summary
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
516
Start Date
2019-05-24
Completion Date
2026-05
Last Updated
2025-04-20
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
Administered orally
Placebo
Administered orally
Topical corticosteroid
Administered as standard-of-care
Locations (78)
Instituto de Neumonología Y Dermatología
Capital Federal, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundacion CIDEA
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Medizinische Universität Wien
Vienna, Vienna, Austria
Sozialmedizinisches Zentrum Ost/Donauspital
Vienna, Vienna, Austria
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro, Brazil
Hospital do Servidor Público Estadual - IAMSPE - centro de estudos urológicos
São Paulo, Brazil
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, Nový Jičín, Czechia
Fakultni Nemocnice v Motol
Prague, Praha 5, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, Czechia
Sanatorium profesora Arenbergera
Prague, Czechia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-Maritimes, France
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Finistère, France
Hôpital Saint Vincent de Paul
Lille, Hauts-de-France, France
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, France
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, Hungary
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India
Aakash Healthcare: Super Speciality Hospital -Dwarka
Dwarka, National Capital Territory of Delhi, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Sheba Medical Center
Ramat Gan, Central District, Israel
Emek Medical Center
Afula, Northern District, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan
Takeda Dermatology Skincare Clinic
Sapporo, Hokkaido, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
National Mie Hospital
Tsu, Mie-ken, Japan
Kume Clinic
Sakai, Osaka, Japan
Senri-Chuo Hanafusa Dermatology Clinic
Toyonaka, Osaka, Japan
Dokkyo Medical University Hospital
Shimotsuga, Tochigi, Japan
Matsuda Tomoko Dermatological Clinic
Fukuoka, Japan
Shinjuku Minamiguchi Hifuka
Tokyo, Japan
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara, Jalisco, Mexico
Centro Regiomontano de Investigación
Monterrey, Nuevo León, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico
Arké SMO S.A de C.V
Veracruz, Mexico
Diamond Clinic
Krakow, Lesser Poland Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
Lodz, Łódź Voivodeship, Poland
Krasnodar Clinical Skin and Venereal Diseases Dispensary
Krasnodar, Krasnodarskiy Kray, Russia
Children's Health Research Center of RAMS
Moscow, Moscow, Russia
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology - Central branch
Moscow, Moscow, Russia
Tula Regional Clinical Dermatovenerological Dispensary
Tula, Tula Oblast, Russia
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, Taiwan
Royal Hospital for Sick Children
Glasgow, Glasgow City, United Kingdom
St Thomas's Hospital
London, London, City of, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom