A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Last updated: June 19, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Fever

Arthritis And Arthritic Pain (Pediatric)

Rheumatoid Arthritis

Treatment

Placebo

Tocilizumab

Baricitinib

Clinical Study ID

NCT04088396
16275
I4V-MC-JAHU
2017-004495-60
2023-507883-38-00
  • Ages 1-17
  • All Genders

Study Summary

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA)as defined by International League of Associations for Rheumatology (ILAR) criteriawith onset before the age of 16 years

  • Participants must have at least 2 active joints at screening and baseline

  • Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year andless than 18 years of age, except in countries that restrict use of tocilizumab inparticipants less than 2 years of age

  • Cohort 2 (open-label baricitinib): Participants who are at least 1 year and lessthan 18 years of age

Exclusion

Exclusion Criteria:

  • Participants must not have polyarticular JIA (positive or negative for rheumatoidfactor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriaticarthritis

  • Participants must not have persistent oligoarticular arthritis as defined by theILAR criteria

  • Participants must not have a history or presence of any autoimmune inflammatorycondition other than JIA

  • Participants must not have active anterior uveitis or are receiving concurrenttreatment for anterior uveitis

  • Participants must not have active fibromyalgia or other chronic pain conditionsthat, in the investigator's opinion, would make it difficult to appropriately assessdisease activity for the purposes of this study

  • Participants must not have biologic features of Macrophage Activation Syndrome (MAS)over the past 12 weeks

  • Participants must not have a current or recent (<4 weeks prior to baseline)clinically serious infection

  • Participants must not have a positive test for hepatitis B virus

  • Participants must not have evidence of active tuberculosis (TB) or untreated latentTB

Study Design

Total Participants: 58
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 12, 2020
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Instituto CAICI SRL

    Rosario, S2000
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. de Tucuman, T4000AXL
    Argentina

    Completed

  • UZ Gent-Reuma

    Gent, East Flanders 9000
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UZ Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • Faculdade de Medicina de Botucatu

    Botucatu, São Paulo 18618-970
    Brazil

    Active - Recruiting

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    Sao Paulo, São Paulo 05403-000
    Brazil

    Active - Recruiting

  • Faculdade de Medicina da UNESP

    Botucatu, 18618-686
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • IPITEC

    São Paulo, 01221-020
    Brazil

    Site Not Available

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-001
    Brazil

    Active - Recruiting

  • IPITEC

    São Paulo 3448439, 01221-020
    Brazil

    Site Not Available

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Universidade Federal de Sao Paulo

    São Paulo 3448439, 04022-001
    Brazil

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno, 613 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808
    Czechia

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandoeuvre lès Nancy, Meurthe-et-Moselle 54500
    France

    Suspended

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, 69500
    France

    Completed

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029
    France

    Completed

  • GH Necker - Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • Christian Medical College Vellore

    Vellore, Tamil Nadu 632 004
    India

    Completed

  • Sir Ganga Ram Hospital

    New Delhi, 110060
    India

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, 49202
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • ASST Spedali Civili - Università degli Studi

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

    Chieti, 66100
    Italy

    Completed

  • Ospedale SS. Annunziata

    Chieti, 66100
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147
    Italy

    Completed

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milan, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Completed

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milan 6951411, 20122
    Italy

    Active - Recruiting

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milano, 20122
    Italy

    Active - Recruiting

  • University of Naples Federico II

    Naples, 80131
    Italy

    Completed

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90127
    Italy

    Active - Recruiting

  • Ospedale Infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Active - Recruiting

  • Tokyo Medical And Dental University Medical Hospital

    Bunkyō, Tokyo 113-8510
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō, 113-8510
    Japan

    Active - Recruiting

  • Chiba Children's Hospital

    Chiba, 266-0007
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital

    Sendai, 989-3126
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686
    Japan

    Active - Recruiting

  • Kanagawa Children's Medical Center

    Yokohama, 232-8555
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama, 236-0004
    Japan

    Active - Recruiting

  • Kanagawa Children's Medical Center

    Yokohama 1848354, 232-8555
    Japan

    Active - Recruiting

  • Clinstile, S.A. de C.V.

    Mexico, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • CREA de Guadalajara, S.C.

    Guadalajara, Jalisco 44620
    Mexico

    Active - Recruiting

  • Hospital Univ. "Dr. José Eleuterio González"

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Active - Recruiting

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000
    Mexico

    Completed

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000
    Mexico

    Completed

  • Crea de Guadalajara

    Guadalajara, 44600
    Mexico

    Completed

  • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León

    Monterrey, 66460
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    México, 06700
    Mexico

    Completed

  • Szpital Dzieciecy Sw. Ludwika

    Krakow, Małopolskie 31-503
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Łódź, Łódzkie 91-738
    Poland

    Active - Recruiting

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

    Krakow, 31-503
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 91-738
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid 3117735, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Dokuz Eylül Üniversitesi

    Izmir, Balçova 35340
    Turkey

    Active - Recruiting

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, 34098
    Turkey (Türkiye)

    Active - Recruiting

  • 9 Eylul University Hospital

    Izmir, 35340
    Turkey (Türkiye)

    Active - Recruiting

  • The John Radcliffe Hospital

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, L12 2AB
    United Kingdom

    Completed

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH
    United Kingdom

    Completed

  • Oxford University Hospitals - Nuffield Orthopaedic Centre

    Oxford, OX3 7HE
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Completed

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