NCT ID: NCT03952559
Last Updated: June 29, 2023
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
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.
Status: ACTIVE_NOT_RECRUITING
Phase: Phase 3
Gender: ALL
Age: 2 Years - 17 Years
Condition: Atopic Dermatitis
Study Type: Interventional
Lead Sponsor: Eli Lilly and Company
Ages Eligible for Study: 2 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria: * At or above the 5th percentile of weight for age. * Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old). * Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. * Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). * Agree to use emollients daily. Exclusion Criteria: * Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. * A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. * Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. * Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). * Have been treated with the following therapies: * Monoclonal antibody for less than 5 half-lives prior to beginning study treatment. * Received prior treatment with any oral Janus kinase (JAK) inhibitor. * Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study. * Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug. * Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height. * Have had major surgery within the past eight weeks or are planning major surgery during the study. * Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. * Have a history of VTE or are considered at high risk of VTE as deemed by the investigator. * Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. * Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis. * Have specific laboratory abnormalities. * Have received certain treatments that are contraindicated. * Pregnant or breastfeeding.
Collaborators: Incyte Corporation
Investigators: 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)
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Centro de Investigaciones Metabólicas (CINME) Caba, Buenos Aires, Argentina |
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Instituto de Neumonología Y Dermatología Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina |
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Centro Medico Dra. De Salvo Capital Federal, Argentina |
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Fundacion CIDEA Ciudad Autonoma Buenos Aires, Argentina |
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The Sydney Children's Hospitals Network Westmead, New South Wales, Australia |
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Veracity Clinical Research Woolloongabba, Queensland, Australia |
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Royal Children's Hospital Melbourne, Victoria, Australia |
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Universitätsklinikum Graz Graz, Steiermark, Austria |
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Medizinische Universität Wien Wien, Vienna, Austria |
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Sozialmedizinisches Zentrum Ost/Donauspital Vienna, Wien, Austria |
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Hospital de Clinicas de Porto Alegre Porto Alegre, Rio Grande Do Sul, Brazil |
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Fundação Faculdade de Medicina do ABC Santo André, Sao Paulo, Brazil |
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Instituto Brasil de Pesquisa Clínica - IBPCLIN Rio de Janeiro, Brazil |
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IDERJ - Instituto de Dermatologia e Estética do Brasil Rio de Janeiro, Brazil |
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Hospital de Servidor Publico Estadual São Paulo, Brazil |
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Fakultni Nemocnice v Motole Praha 5, Hl. M. Praha, Czechia |
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Fakultni nemocnice Bulovka Praha 8, Hl. M. Praha, Czechia |
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Nemocnice AGEL Novy Jicin a.s. Novy Jicin, Moravskoslezsky Kraj, Czechia |
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Fakultni nemocnice Hradec Kralove Hradec Kralove, Czechia |
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Sanatorium profesora Arenbergera Praha 2, Czechia |
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Hopital Saint Eloi Montpellier Cédex 05, Montpellier, France |
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CHRU de Brest - Hôpital Morvan Brest, France |
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Hôpital Saint Vincent de Paul Lille, France |
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Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Cedex 1, France |
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CHU de Nice Hopital de L'Archet Nice, France |
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Hopitaux Drome-Nord Romans-sur-Isere, France |
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Hopital Larrey Toulouse, France |
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Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main, Hessen, Germany |
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Universitätsklinikum Münster Münster, Nordrhein-Westfalen, Germany |
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Universitätsklinikum Carl Gustav Carus Dresden, Sachsen, Germany |
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Katholisches Kinderkrankenhaus Wilhelmstift Hamburg, Germany |
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SZTE AOK Borgyogyaszati es Allergologiai Klinika Szeged, Csongrad, Hungary |
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Allergo-Derm Bakos Kft Szolnok, Jasz-Nagykun-Szolnok, Hungary |
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All India Institute of Medical Sciences New Delhi, Delhi, India |
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Sir Ganga Ram Hospital New Delhi, Delhi, India |
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B. J. Medical College & Civil Hospital Ahmedabad, Gujarat, India |
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Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital Nagpur, Maharashtra, India |
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Dr. D. Y. Patil Medical College & Hospital Navi Mumbai, Maharashtra, India |
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Acharya Vinoba Bhave Rural Hospital Wardha, Maharashtra, India |
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Lady Harding Medical College & Hospital Delhi, New Delhi, India |
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Lifepoint Multispecialty Hsptl Wakad, Pune, India |
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Postgraduate Institute of Medical Education & Research Chandigarh, Punjab, India |
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Aakash Healthcare Super Speciality Hospital New Delhi, India |
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Sheba Medical Center Ramat Gan, HaMerkaz, Israel |
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Ha'Emek Medical Center Afula, Israel |
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Soroka Medical Center Beer Sheva, Israel |
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Tel Aviv Sourasky Medical Center Tel Aviv, Israel |
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Nagoya Medical Center Nagoya, Aichi, Japan |
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Fukuyama City Hospital Fukuyama, Hiroshima, Japan |
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Takeda Dermatology Skincare Clinic Sapporo, Hokkaido, Japan |
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National Sagamihara Hospital Sagamihara, Kanagawa, Japan |
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Japan National Hospital Organization Mie Hospital Tsu-shi, Mie, Japan |
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Dermatology and Ophthalmology Kume Clinic Sakai City, Osaka, Japan |
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Senri-Chuo Hanafusa Dermatology Clinic Toyonaka, Osaka, Japan |
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Dokkyo Medical University Hospital Shimotsuga, Tochigi, Japan |
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Matsuda Tomoko Dermatological Clinic Fukuoka, Japan |
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Shinjuku Minamiguchi Hifuka Tokyo, Japan |
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Consultorio Privado de la Dra. Villanueva Guadalajara, Jalisco, Mexico |
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Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey, NL, Mexico |
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Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango, Mexico |
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CRI Centro Regiomontano de Investigación Monterrey, Mexico |
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Arke Estudios Clinicos S.A. de C.V. Veracruz, Mexico |
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Dermed Centrum Medyczne Sp. z o.o. Lodz, Lodzkie, Poland |
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Diamond Clinic Krakow, Małopolskie, Poland |
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Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk, Pomorskie, Poland |
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GBUZ Clinical dermatology and venereological dispensary Krasnodar, Krasnodarskiy Kray, Russian Federation |
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Scientific Center of Children's Health Moscow, Moskva, Russian Federation |
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Tula Regional Clinical Dermatovenerological Dispensary Tula, Tul'skaya Oblast', Russian Federation |
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Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology Moscow, Russian Federation |
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Hospital Sant Joan de Déu Esplugues de Llobregat, Barcelona [Barcelona], Spain |
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Hospital Infantil Universitario Niño Jesús Madrid, Madrid, Comunidad De, Spain |
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Hospital Univ. Puerta de Hierro Majadahonda, Madrid, Spain |
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Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon, Madrid, Spain |
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Clinica Universitaria De Navarra Pamplona, Navarra, Spain |
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Clinica Universidad Navarra-Sede Madrid Madrid, Spain |
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Hospital Universitario La Paz Madrid, Spain |
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Centro de Especialidades Mollabao Pontevedra, Spain |
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Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City, Taiwan |
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Chung Shan Medical University Hospital Taichung City, Taiwan |
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National Taiwan University Hospital Taipei City, Taiwan |
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Taipei Veterans General Hospital Taipei City, Taiwan |
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Chang Gung Memorial Hospital - Taipei Taipei, Taiwan |
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Chang Gung Memorial Hospital - Linkou Taoyuan City, Taiwan |
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St Thomas's Hospital Waterloo, London, United Kingdom |
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Queen's Medical Centre, Nottingham University Hospitals Nottingham, Nottinghamshire, United Kingdom |
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Royal Hospital for Children Glasgow, United Kingdom |
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