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

NCT03952559 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: 16966I4V-MC-JAIP2018-000349-38
• Study Type: interventional
• Target: 516
• Locations: 16 countries
• Sites: 75

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

Keywords

eczema; atopic eczema

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement

  Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

  Week 16

• Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

  Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.

  Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

• Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

  Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.

  Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose

Secondary Outcomes (31)

• Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

  Week 16

• Percentage of Participants Achieving EASI90

  Week 16

• Change From Baseline in EASI Score

  Baseline, Week 16

• Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

  Week 16

• Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry

  Week 16

Study Arms (5)

Baricitinib Open Label High Dose (PK Lead-in)

EXPERIMENTAL

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.

Drug: Baricitinib; Drug: Topical corticosteroid

Baricitinib High Dose

EXPERIMENTAL

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.

Drug: Baricitinib; Drug: Topical corticosteroid

Baricitinib Medium Dose

EXPERIMENTAL

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.

Drug: Baricitinib; Drug: Topical corticosteroid

Baricitinib Low Dose

EXPERIMENTAL

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.

Drug: Baricitinib; Drug: Topical corticosteroid

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Topical corticosteroid

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib High Dose; Baricitinib Low Dose; Baricitinib Medium Dose; Baricitinib Open Label High Dose (PK Lead-in)

Placebo DRUG

Administered orally

Placebo

Topical corticosteroid DRUG

Administered as standard-of-care

Baricitinib High Dose; Baricitinib Low Dose; Baricitinib Medium Dose; Baricitinib Open Label High Dose (PK Lead-in); Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Incyte Corporation: collaborator

Study Sites (78)

Instituto de Neumonología Y Dermatología

Capital Federal, Buenos Aires, 1425, Argentina

Location

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027, Argentina

Location

Fundacion CIDEA

Buenos Aires, Ciudad Autonoma Buenos Aires, C1121ABE, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Medizinische Universität Wien

Vienna, State of Vienna, 1090, Austria

Location

Sozialmedizinisches Zentrum Ost/Donauspital

Vienna, State of Vienna, 1220, Austria

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

Location

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 22241-180, Brazil

Location

IDERJ - Instituto de Dermatologia e Estética do Brasil

Rio de Janeiro, 22470-220, Brazil

Location

Hospital do Servidor Público Estadual - IAMSPE - centro de estudos urológicos

São Paulo, 04039-901, Brazil

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, 500 05, Czechia

Location

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, Nový Jičín, 741 01, Czechia

Location

Fakultni Nemocnice v Motol

Prague, Praha 5, 150 06, Czechia

Location

Fakultni nemocnice Bulovka

Prague, Praha 8, 180 81, Czechia

Location

Sanatorium profesora Arenbergera

Prague, 128 00, Czechia

Location

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, Alpes-Maritimes, 6200, France

Location

Hôpitaux Drôme Nord - Romans

Romans-sur-Isère, Drôme, 26102, France

Location

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Finistère, 29200, France

Location

Hôpital Saint Vincent de Paul

Lille, Hauts-de-France, 59020, France

Location

Chu Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

Location

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

Nantes, Loire-Atlantique, 44093, France

Location

CHU de Toulouse - Hopital Larrey

Toulouse, Midi-Pyrénées, 31400, France

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

Location

Katholisches Kinderkrankenhaus Wilhelmstift

Hamburg, 22149, Germany

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, 6720, Hungary

Location

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

Aakash Healthcare: Super Speciality Hospital -Dwarka

Dwarka, National Capital Territory of Delhi, 110075, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Emek Medical Center

Afula, Northern District, 1834111, Israel

Location

Soroka Medical Center

Beersheba, Southern District, 8410101, Israel

Location

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Fukuyama City Hospital

Fukuyama, Hiroshima, 721-8511, Japan

Location

Takeda Dermatology Skincare Clinic

Sapporo, Hokkaido, 004-0063, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

National Mie Hospital

Tsu, Mie-ken, 514-0125, Japan

Location

Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka, Osaka, 560-0085, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga, Tochigi, 321-0293, Japan

Location

Matsuda Tomoko Dermatological Clinic

Fukuoka, 819-0167, Japan

Location

Shinjuku Minamiguchi Hifuka

Tokyo, 160-0023, Japan

Location

Centro de Atención en Enfermedades Inflamatorias CATEI

Guadalajara, Jalisco, 44638, Mexico

Location

Centro Regiomontano de Investigación

Monterrey, Nuevo León, 64060, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 66460, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91900, Mexico

Location

Diamond Clinic

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Krasnodar Clinical Skin and Venereal Diseases Dispensary

Krasnodar, Krasnodarskiy Kray, 354057, Russia

Location

Children's Health Research Center of RAMS

Moscow, Moscow, 115478, Russia

Location

Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology - Central branch

Moscow, Moscow, 127473, Russia

Location

Tula Regional Clinical Dermatovenerological Dispensary

Tula, Tula Oblast, 300053, Russia

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 8950, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, 28222, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

CHOP-Centro De Especialidades De Mollabao

Pontevedra, Pontevedra [Pontevedra], 36001, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan District, 333, Taiwan

Location

Royal Hospital for Sick Children

Glasgow, Glasgow City, G514TF, United Kingdom

Location

St Thomas's Hospital

London, London, City of, SE1 7EH, United Kingdom

Location

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39522957 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

baricitinib; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-595-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants were randomized to one of the four double-blind treatment arms. A separate group of 33 participants received open label baricitinib as part of pharmacokinetic (PK) lead-in (not randomized) period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: May 24, 2019
• Primary Completion: April 24, 2022
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026
• Results First Posted: June 29, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

TW (6); BR (5); AU (3); FR (7); HU (2); IN (3); AR (4); PL (3); CZ (5); ES (7); IL (4); GB (3); DE (4); RU (4); ME (5); JP (10)