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

NCT ID: NCT03952559

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Baricitinib Open Label High Dose (PK Lead-in)

Participants 10 to < 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.

Participants 2 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Topical corticosteroid

Intervention Type: DRUG

Administered as standard-of-care

Baricitinib High Dose

Participants 10 to < 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Topical corticosteroid

Intervention Type: DRUG

Administered as standard-of-care

Baricitinib Medium Dose

Participants 10 to < 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to < 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Topical corticosteroid

Intervention Type: DRUG

Administered as standard-of-care

Baricitinib Low Dose

Participants 10 to < 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.

Participants 2 to < 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Topical corticosteroid

Intervention Type: DRUG

Administered as standard-of-care

Placebo

Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Topical corticosteroid

Intervention Type: DRUG

Administered as standard-of-care

Interventions

Baricitinib

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Topical corticosteroid

Administered as standard-of-care

Intervention Type: DRUG

Other Intervention Names

LY3009104

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Argentina; Australia; Austria; Brazil; Czechia; France; Germany; Hungary; India; Israel; Japan; Mexico; Poland; Russia; Spain; Taiwan; United Kingdom

References

Wollenberg A, Ikeda M, Chu CY, Eichenfield LF, Seyger MMB, Prakash A, Angle R, Zhu D, Pontes M, Paller AS. Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years. J Dermatolog Treat. 2024 Dec;35(1):2411834. doi: 10.1080/09546634.2024.2411834. Epub 2024 Nov 10.

Reference Type: DERIVED

PMID: 39522957 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/B796sBY99npuSW6LYeHAk

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)

Other Identifiers

I4V-MC-JAIP

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000349-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16966

Identifier Type: -

Identifier Source: org_study_id