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ACTIVE NOT RECRUITING
NCT03952559
PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Interventions

DRUG

Baricitinib

Administered orally

DRUG

Placebo

Administered orally

DRUG

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