Clinical Trial Details for

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

NCT ID: NCT03952559

Last Updated: September 17, 2020

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.

The Study at a Glance

Status: Recruiting

Phase: Phase 3

Gender: All

Age: 2 Years - 17 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Eli Lilly and Company

Eligibility

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.

Additional Information, Locations & Contacts

Collaborators: Not provided

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)

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

Centro de Investigaciones Metabólicas (CINME)

Caba, Buenos Aires, Argentina

Centro Medico Dra. De Salvo

Capital Federal, Argentina

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, Argentina

The Sydney Children's Hospitals Network

Westmead, New South Wales, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Royal Childrens Hospital Melbourne

Parkville, Victoria, Australia

Universitätsklinikum Graz

Graz, Steiermark, Austria

Medizinische Universität Wien

Wien, Vienna, Austria

Sozialmedizinisches Zentrum Ost/Donauspital

Vienna, Wien, Austria

IDERJ - Instituto de Dermatologia e Estética do Brasil

Rio de Janeiro, RJ, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, RS, Brazil

Fundação Faculdade de Medicina do ABC

Santo André, Sao Paulo, Brazil

Instituto Brasil de Pesquisa Clínica - IBPCLIN

Rio de Janeiro, Brazil

Hospital de Servidor Publico Estadual

São Paulo, Brazil

Fakultni Nemocnice v Motole

Praha 5, Hl. M. Praha, Czechia

Nemocnice Na Bulovce

Praha 8, Hl. M. Praha, Czechia

Kozni oddeleni

Novy Jicin, Moravskoslezsky Kraj, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia

Sanatorium profesora Arenbergera

Praha 1, Czechia

Centre Hospitalier Victor Dupouy Argenteuil

Argenteuil, Cedex, France

CHRU de Brest - Hôpital Morvan

Brest, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes Cedex 1, France

CHU de Nice Hopital de L'Archet

Nice, France

Hopital Larrey

Toulouse, France

Centre Hospitalier de Valence

Valence, France

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hessen, Germany

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Sachsen, Germany

Katholisches Kinderkrankenhaus Wilhelmstift

Hamburg, Germany

Oroshaza Varosi Onkormanyzat Korhaza

Oroshaza, Bekes, Hungary

SZTE AOK Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrad, Hungary

Allergo-Derm Bakos Kft

Szolnok, Jasz-Nagykun-Szolnok, Hungary

All India Institute of Medical Sciences

New Delhi, Delhi, India

Sir Ganga Ram Hospital

New Delhi, Delhi, India

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, India

GMERS Medical College & Hospital

Vadodara, Gujarat, India

Dr. D. Y. Patil Medical College & Hospital

Navi Mumbai, Maharashtra, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharshtra, India

Lifepoint Multispecialty Hsptl

Wakad, Pune, India

Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab, India

Maulana Azad Medical College & LNJP, GB Pant Hospitals

New Delhi, India

Aakash Healthcare Super Speciality Hospital

New Delhi, India

Ha'Emek Medical Center

Afula, Israel

Soroka Medical Center

Beer Sheva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Nagoya Medical Center

Nagoya, Aichi, Japan

Fukuyama City Hospital

Fukuyama-shi, Hiroshima, Japan

Takeda Derm Skin Care Clin

Sapporo-city, Hokkaido, Japan

National Sagamihara Hospital

Sagamihara, Kanagawa, Japan

Japan National Hospital Organization Mie Hospital

Tsu-shi, Mie, Japan

Kume Clinic

Sakai City, Osaka, Japan

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka-shi, Osaka, Japan

Dokkyo Medical University Hospital

Shimotsuga-Gun, Tochigi, Japan

Tokyo Rosai Hospital

Ota-Ku, Tokyo, Japan

Shinjuku Minamiguchi Dermatology

Shinjuku-ku, Tokyo, Japan

Matsuda Tomoko Dermatological Clinic

Fukuoka, Japan

Consultorio Privado de la Dra. Villanueva

Guadalajara, Jalisco, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, NL, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, Mexico

CRI Centro Regiomontano de Investigación

Monterrey, Mexico

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

Veracruz, Mexico

Dermed Centrum Medyczne Sp. z o.o.

Lodz, Lodzkie, Poland

Diamond Clinic

Krakow, Malopolskie, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomorskie, Poland

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, Krasnodarskiy Kray, Russian Federation

State Healthcare Instit Tula Reg Dermatov Dispensary

Tula, Tul'skaja Oblast, Russian Federation

Pirogov Russian National Research Medical University

Moscow, Russian Federation

Scientific Center of Children's Health

Moscow, Russian Federation

Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

Moscow, Russian Federation

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Hospital Univ. Puerta de Hierro

Majadahonda, Madrid, Spain

Clinica Universitaria De Navarra

Pamplona, Navarra, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Clinica Universidad Navarra-Sede Madrid

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Centro de Especialidades Mollabao

Pontevedra, Spain

Universitäts-Kinderspital beider Basel UKBB

Basel, Basel Stadt, Switzerland

Universitäts-Kinderspital Zürich

Zürich, Switzerland

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Taiwan

Taipei Medical University- Shuang Ho Hospital

New Taipei City, Taiwan

Chung Shan Medical University Hospital

Taichung City, Taiwan

National Taiwan University Hospital

Taipei City, Taiwan

Chang Gung Memorial Hospital - Taipei

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, Taiwan

St Thomas's Hospital

Waterloo, London, United Kingdom

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, Nottinghamshire, United Kingdom

Royal Hospital for Children

Glasgow, United Kingdom