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Clinical Trial Details for A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis


Eli Lilly and Company
NCT ID: NCT03952559
Last Updated: September 2, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 2 Years - 17 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Eli Lilly and Company
  • Location: Not Provided

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

Purpose

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.

Eligibility

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Eli Lilly and Company

Incyte Corporation

Investigators

Study Director: 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)

Eli Lilly and Company

Please refer to this study by its ClinicalTrials.gov identifier: NCT03952559

Location

Contacts

Centro Medico Dra. De Salvo

Capital Federal, C1426ABP

Argentina

Centro de Investigaciones Metabólicas (CINME) - Comite

Ciudad Autonoma Buenos Aires, C1056ABJ

Argentina

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, C1121ABE

Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, C1425BEA

Argentina

The Sydney Children's Hospitals Network

Westmead, New South Wales 2145

Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland 4102

Australia

Eastern Clinical Research Unit

Box Hill, Victoria 3128

Australia

Royal Childrens Hospital Melbourne

Parkville, Victoria 3050

Australia

Universitätsklinikum Graz

Graz, Steiermark 8036

Austria

Medizinische Universität Wien - Kinder und Jugendheilkunde

Wien, Vienna 1090

Austria

Sozialmed. Zentrum Ost - Donauspital

Wien, 1220

Austria

IDERJ - Instituto de Dermatologia e Estética do Brasil

Rio de Janeiro, RJ 22470-220

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, RS 90035-903

Brazil

Fundação Faculdade de Medicina do ABC

Santo André, Sao Paulo 09060-650

Brazil

IMA Brasil - Instituto de Medicina Avançada

Sao Paulo, 05437-010

Brazil

Hospital de Servidor Publico Estadual

São Paulo, 04039-901

Brazil

Fakultni Nemocnice v Motole

Praha 5, Hl. M. Praha 150 06

Czechia

Nemocnice Na Bulovce

Praha 8, Hl. M. Praha 180 81

Czechia

Nemocnice Novy Jicin a.s.

Novy Jicin, Moravskoslezsky Kraj 741 01

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Kralove, 500 05

Czechia

Sanatorium Profesora Arenbergera

Praha 1, 110 00

Czechia

Centre Hospitalier Victor Dupouy Argenteuil

Argenteuil, Cedex 95107

France

CHRU de Brest - Hôpital Morvan

Brest, 29200

France

Chru De Nantes Hotel-Dieu

Nantes Cedex 1, 44093

France

CHU de Nice Hopital de L'Archet

Nice, 06202

France

Hopital Larrey

Toulouse, 31059

France

Centre Hospitalier de Valence

Valence, 26953

France

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hessen 60590

Germany

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen 48149

Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rheinland-Pfalz 55131

Germany

Katholisches Kinderkrankenhaus Wilhelmstift

Hamburg, 22149

Germany

Oroshaza Varosi Onkormanyzat Korhaza

Oroshaza, Bekes 5900

Hungary

SZTE AOK Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrad 6720

Hungary

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

Debrecen, Hajdu-Bihar 4032

Hungary

Allergo-Derm Bakos Kft

Szolnok, Jasz-Nagykun-Szolnok 5000

Hungary

All India Institue of Medical Sciences (AIIMS)

New Delhi, Delhi 110 029

India

Sir Ganga Ram Hospital

New Delhi, Delhi 110060

India

Byramjee Jeejeebhoy Medical College & Civil Hospital

Ahmedabad, Gujarat 380016

India

GMERS Medical College & Hospital

Vadodara, Gujarat 390021

India

Sumandeep Vidhyapeeth & Dhiraj General Hospital

Vadodara, Gujarat 391760

India

Seth GS Medical College & KEM Hospital

Mumbai, Maharshtra 400012

India

Lifepoint Multispecialty Hospital

Wakad, Pune 411057

India

Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab 160012

India

Maulana Azad Medical College & LNJP, GB Pant Hospitals

New Delhi, 110 002

India

Ha'Emek Medical Center

Afula, 18101

Israel

Soroka Medical Center

Beer Sheva, 8410101

Israel

Sheba Medical Center

Ramat Gan, 5266202

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Nagoya Medical Center

Nagoya, Aichi 460-0001

Japan

Fukuyama City Hospital

Fukuyama-shi, Hiroshima 721-8511

Japan

National Sagamihara Hospital

Sagamihara, Kanagawa 252-0392

Japan

National Hospital Organization Mie Hospital

Tsu-shi, Mie 514-0125

Japan

Kume Clinic

Nishi-ku Sakai-shi, Osaka 593-8324

Japan

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka-shi, Osaka 560-0085

Japan

Dokkyo Medical University Hospital

Shimotsuga-Gun, Tochigi 321 0293

Japan

Tokyo Rosai Hospital

Ota-Ku, Tokyo 143-0013

Japan

Shinjuku Minamiguchi Dermatology

Shinjuku-ku, Tokyo 160-0023

Japan

Matsuda Tomoko Dematological Clinic

Fukuoka, 819 0167

Japan

Consultorio Privado de la Dra. Villanueva

Guadalajara, Jalisco 44657

Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, NL 64460

Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, 34000

Mexico

CRI Centro Regiomontano de Investigación

Monterrey, 64060

Mexico

Arke Estudios Clinicos S.A. de C.V.

Veracruz, 91910

Mexico

Centrum Badan Klinicznych, PI House

Gdansk, 80-546

Poland

Barbara Rewerska DIAMOND CLINIC

Krakow, 31-209

Poland

Dermed Centrum Medyczne Sp. z o.o.

Lodz, 90-265

Poland

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, 350020

Russian Federation

State scientific centre for dermatovenerology and cosmetolog

Moscow, 107076

Russian Federation

Pirogov Russian National Research Medical University

Moscow, 117997

Russian Federation

Center of Children`s Health

Moscow, 119991

Russian Federation

Russian state medical-stomatological university n.a. Evdokimov

Moscow, 125206

Russian Federation

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona 08950

Spain

Hospital Univ. Puerta de Hierro

Majadahonda, Madrid 28220

Spain

Clinica Universitaria De Navarra

Pamplona, Navarra 31008

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Infantil Niño Jesus

Madrid, 28009

Spain

Clinica Universidad Navarra-Sede Madrid

Madrid, 28022

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Centro de Especialidades Mollabao

Pontevedra, 36001

Spain

Universitäts-Kinderspital beider Basel UKBB

Basel, Basel Stadt 4056

Switzerland

Universitäts-Kinderspital Zürich

Zürich, 8032

Switzerland

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 83301

Taiwan

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 23561

Taiwan

Chung Shan Medical University Hospital

Taichung City, 40201

Taiwan

National Taiwan University Hospital

Taipei City, 10048

Taiwan

Chang Gung Memorial Hospital - Taipei

Taipei, 10508

Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 33305

Taiwan

Queen's MedicaL Centre/University of Nottingham

Nottingham, Nottinghamshire NG7 2UH

United Kingdom

Guys/St. Thomas Hospital

London, Surrey SE1 9RT

United Kingdom

Royal Hospital for Children

Glasgow, G514TF

United Kingdom