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Активно (без набиране) Фаза 3 NCT03952559

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Atopic Dermatitis

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Baricitinib
DRUG
Placebo
DRUG
Topical corticosteroid
DRUG
Места на провеждане 78
Argentina (4)
Fundacion CIDEA
Buenos Aires , Ciudad Autonoma Buenos Aires
Fundación Respirar
Buenos Aires
Instituto de Neumonología Y Dermatología
Capital Federal , Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires , Buenos Aires
Австралия (3)
Royal Children's Hospital
Melbourne , Victoria
The Children's Hospital at Westmead
Westmead , New South Wales
Veracity Clinical Research
Woolloongabba , Queensland
Австрия (3)
Medizinische Universität Graz
Graz , Styria
Medizinische Universität Wien
Vienna , State of Vienna
Sozialmedizinisches Zentrum Ost/Donauspital
Vienna , State of Vienna
Бразилия (5)
Hospital de Clinicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro
Faculdade de Medicina do ABC
Santo André , São Paulo
Hospital do Servidor Público Estadual - IAMSPE - centro de estudos urológicos
São Paulo
Чехия (5)
Fakultni nemocnice Hradec Kralove
Hradec Králové , Hradec Králové
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín , Nový Jičín
Fakultni Nemocnice v Motol
Prague , Praha 5
Fakultni nemocnice Bulovka
Prague , Praha 8
Sanatorium profesora Arenbergera
Prague
Франция (7)
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest , Finistère
Hôpital Saint Vincent de Paul
Lille , Hauts-de-France
Chu Saint Eloi
Montpellier , Languedoc-Roussillon
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes , Loire-Atlantique
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice , Alpes-Maritimes
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère , Drôme
CHU de Toulouse - Hopital Larrey
Toulouse , Midi-Pyrénées
Германия (4)
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden , Saxony
Universitätsklinikum Frankfurt
Frankfurt am Main , Hesse
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg
Universitätsklinikum Münster
Münster , North Rhine-Westphalia
Унгария (2)
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged , Csongrád megye
Allergo-Derm Bakos Kft
Szolnok , Jász-Nagykun-Szolnok
Индия (3)
B. J. Medical College & Civil Hospital
Ahmedabad , Gujarat
Aakash Healthcare: Super Speciality Hospital -Dwarka
Dwarka , National Capital Territory of Delhi
Sir Ganga Ram Hospital
New Delhi , National Capital Territory of Delhi
Израел (4)
Emek Medical Center
Afula , Northern District
Soroka Medical Center
Beersheba , Southern District
Sheba Medical Center
Ramat Gan , Central District
Sourasky Medical Center
Tel Aviv , Tell Abīb
Япония (10)
Matsuda Tomoko Dermatological Clinic
Fukuoka
Fukuyama City Hospital
Fukuyama , Hiroshima
Nagoya Medical Center
Nagoya , Aichi-ken
National Hospital Organization Sagamihara National Hospital
Sagamihara , Kanagawa
Kume Clinic
Sakai , Osaka
Takeda Dermatology Skincare Clinic
Sapporo , Hokkaido
Dokkyo Medical University Hospital
Shimotsuga , Tochigi
Shinjuku Minamiguchi Hifuka
Tokyo
Senri-Chuo Hanafusa Dermatology Clinic
Toyonaka , Osaka
National Mie Hospital
Tsu , Mie-ken
Mexico (5)
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara , Jalisco
Centro Regiomontano de Investigación
Monterrey , Nuevo León
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey , Nuevo León
Arké SMO S.A de C.V
Veracruz
Полша (3)
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk , Pomeranian Voivodeship
Diamond Clinic
Krakow , Lesser Poland Voivodeship
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
Lodz , Łódź Voivodeship
Russia (4)
Krasnodar Clinical Skin and Venereal Diseases Dispensary
Krasnodar , Krasnodarskiy Kray
Children's Health Research Center of RAMS
Moscow , Moscow
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology - Central branch
Moscow , Moscow
Tula Regional Clinical Dermatovenerological Dispensary
Tula , Tula Oblast
Испания (7)
Hospital Sant Joan de Déu
Esplugues de Llobregat , Barcelona [Barcelona]
Hospital Infantil Universitario Niño Jesús
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid, Comunidad de
Clinica Universidad de Navarra
Pamplona , Navarre
CHOP-Centro De Especialidades De Mollabao
Pontevedra , Pontevedra [Pontevedra]
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón , Madrid
Taiwan (6)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist , Kaohsiung
Chung Shan Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District
Великобритания (3)
Royal Hospital for Sick Children
Glasgow , Glasgow City
St Thomas's Hospital
London , London, City of
Queen's Medical Centre, Nottingham University Hospitals
Nottingham , Nottinghamshire
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
24.05.2019
Крайна дата
01.05.2026
Регистрационен номер
NCT03952559
Източник
clinicaltrials.gov
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