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

February 9, 2026 updated by: Eli Lilly and Company

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Rosario, Argentina, S2000
        • Recruiting
        • Instituto CAICI SRL
        • Contact:
          • Phone Number: 543414248045
        • Principal Investigator:
          • Diego Viola
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Recruiting
        • Centro Médico Privado de Reumatología
        • Contact:
          • Phone Number: +54-381-4200180
        • Principal Investigator:
          • Alberto Spindler
  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Joke Dehoorne
  • Brazil
      • Botucatu, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP
        • Principal Investigator:
          • Claudia Magalhaes
        • Contact:
          • Phone Number: +551438801476
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Claiton Brenol
        • Contact:
          • Phone Number: 5551999166026
      • São Paulo, Brazil, 01221-020
        • Not yet recruiting
        • IPITEC
        • Principal Investigator:
          • Maria dos Santos
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
        • Principal Investigator:
          • Clovis Silva
        • Contact:
          • Phone Number: 551126618840
      • São Paulo, Brazil, 04024-001
        • Recruiting
        • Universidade Federal de Sao Paulo
        • Principal Investigator:
          • Maria Teresa Terreri
        • Contact:
          • Phone Number: 5511 55792581
  • Czechia
      • Brno, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno
        • Contact:
          • Phone Number: 420532234482
        • Principal Investigator:
          • Marcel Schuller
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Principal Investigator:
          • Pavla Dolezalova
  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
        • Principal Investigator:
          • Alexandre BELOT
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • isabelle Kone-Paut
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
        • Principal Investigator:
          • Tu-Anh TRAN
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Principal Investigator:
          • Pierre Quartier Dit Maire
        • Contact:
          • Phone Number: +33144494828
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • Elisabeth Gervais
  • India
      • New Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Sujata Sawhney
  • Israel
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Ruby Haviv
      • Petah Tikva, Israel, 49202
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Gil Amarilyo
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Irit Tirosh
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di brescia
        • Principal Investigator:
          • Marco Cattalini
      • Chieti, Italy, 66100
        • Completed
        • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
      • Genova, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Principal Investigator:
          • Roberta Caorsi
      • Milan, Italy, 20122
        • Recruiting
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
        • Principal Investigator:
          • Achille Marino
      • Milan, Italy, 20122
        • Completed
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Napoli, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Principal Investigator:
          • Maria Alessio
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
        • Principal Investigator:
          • Maria Cristina Maggio
        • Contact:
          • Phone Number: 39 091 0916666250
      • Trieste, Italy, 34137
        • Recruiting
        • Ospedale Infantile Burlo Garofolo
        • Principal Investigator:
          • Alberto Tommasini
  • Japan
      • Bunkyō, Japan, 113-8510
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Shimizu
      • Chiba, Japan, 266-0007
        • Recruiting
        • Chiba Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Minako Tomiita
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuichi Yamasaki
      • Sendai, Japan, 989-3126
        • Recruiting
        • Miyagi Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Umebayashi
      • Takatsuki, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuko Sugita
      • Yokohama, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichi Ito
      • Yokohama, Japan, 232-8555
        • Recruiting
        • Kanagawa Children's Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoyuki Imagawa
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua
        • Contact:
          • Phone Number: 526144373003
        • Principal Investigator:
          • Cesar Pacheco-Tena
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Clínicas para la Salud
        • Principal Investigator:
          • Edgar Hernandez
        • Contact:
          • Phone Number: +52 1 618 812 5351
      • Guadalajara, Mexico, 44600
        • Recruiting
        • Crea de Guadalajara
        • Principal Investigator:
          • Gabriel Vega Cornejo
      • Monterrey, Mexico, 66460
        • Recruiting
        • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
        • Principal Investigator:
          • Nadina Rubio Perez
        • Contact:
          • Phone Number: 8183338623
      • México, Mexico, 06700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
          • Phone Number: 525552561496
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
  • Poland
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
        • Principal Investigator:
          • Zbigniew Zuber
        • Contact:
          • Phone Number: +48 126198630
      • Lodz, Poland, 91-738
        • Recruiting
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Elzbieta Smolewska
        • Contact:
          • Phone Number: +48426177700
      • Warsaw, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
        • Principal Investigator:
          • Piotr Gietka
  • Spain
      • Esplugues de Llobregat, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu
        • Principal Investigator:
          • Jordi Anton
        • Contact:
          • Phone Number: (34)936009733
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Alina Lucica Boteanu
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Rosa Alcobendas
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
        • Principal Investigator:
          • DANIEL CLEMENTE
        • Contact:
          • Phone Number: 34 915035900-280
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Marisol Camacho Lovillo
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Phone Number: +34961244792
        • Principal Investigator:
          • LUCIA LACRUZ PEREZ
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
        • Principal Investigator:
          • Ozgur Kasapcopur
      • Izmir, Turkey (Türkiye), 35340
        • Recruiting
        • 9 Eylul University Hospital
        • Principal Investigator:
          • Erbil Unsal
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Recruiting
        • Bristol Royal Hospital for Children
        • Principal Investigator:
          • Athimalaipet Ramanan
      • Liverpool, United Kingdom, L12 2AB
        • Recruiting
        • Alder Hey Children's Hospital
        • Principal Investigator:
          • Beverley Almeida
      • London, United Kingdom, WC1N 3JH
        • Completed
        • Great Ormond Street Hospital For Children NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7HE
        • Recruiting
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
        • Principal Investigator:
          • Inga Turtsevich
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Principal Investigator:
          • Daniel Hawley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with 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 and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
  • Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Exclusion Criteria:

  • Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
  • Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
  • Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
  • Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
  • Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease 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 latent TB

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Active Comparator: Cohort 1 Tocilizumab
Tocilizumab given Subcutaneously (SC).
Drug: Tocilizumab
Administered SC
Experimental: Cohort 2 Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Time Frame: Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24
Time Frame: Week 24
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Week 24
Percentage of Participants with Inactive Disease
Time Frame: Week 12
Percentage of Participants with Inactive Disease
Week 12
Percentage of Participants with Minimal Disease Activity
Time Frame: Week 12
Percentage of Participants with Minimal Disease Activity
Week 12
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Time Frame: Baseline, Week 24
Change from Baseline in JADAS-27
Baseline, Week 24
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Time Frame: Baseline, Week 24
Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
Baseline, Week 24
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Time Frame: Baseline through Week 24
PK: Cmax, ss of Baricitinib
Baseline through Week 24
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
Time Frame: Baseline through Week 24
PK: AUC, ss of Baricitinib
Baseline through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16275
  • I4V-MC-JAHU (Other Identifier: Eli Lilly and Company)
  • 2017-004495-60 (EudraCT Number)
  • 2023-507883-38-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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