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

August 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Instituto CAICI SRL
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
  • Belgium
      • Ghent, Belgium, 9000
        • Uz Gent
  • Brazil
      • Botucatu, Brazil, 18618-686
        • Faculdade de Medicina da UNESP
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • São Paulo, Brazil, 01221-020
        • IPITEC
      • São Paulo, Brazil, 04024-001
        • Universidade Federal de Sao Paulo
      • São Paulo, Brazil, 05403-000
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
  • Czechia
      • Brno, Czechia, 613 00
        • Detska nemocnice FN Brno
      • Prague, Czechia, 12808
        • Vseobecna Fakultni nemocnice v Praze
  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon - Hopital Femme Mere Enfant
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
      • Nîmes, France, 30029
        • Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
      • Paris, France, 75015
        • Hôpital Universitaire Necker Enfants Malades
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers
  • India
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
  • Israel
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 49202
        • Schneider Children's Medical Center
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Chieti, Italy, 66100
        • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
      • Genova, Italy, 16147
        • IRCCS Istituto Giannina Gaslini
      • Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
      • Naples, Italy, 80131
        • University of Naples Federico II
      • Palermo, Italy, 90127
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
      • Trieste, Italy, 34137
        • Ospedale Infantile Burlo Garofolo
  • Japan
      • Bunkyō, Japan, 113-8510
        • Institute of Science Tokyo Hospital
      • Chiba, Japan, 266-0007
        • Chiba Children's Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Sendai, Japan, 989-3126
        • Miyagi Children's Hospital
      • Takatsuki, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
      • Yokohama, Japan, 236-0004
        • Yokohama City University Hospital
      • Yokohama, Japan, 232-8555
        • Kanagawa Children's Medical Center
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua
      • Durango, Mexico, 34000
        • Instituto de Investigaciones Clínicas para la Salud
      • Guadalajara, Mexico, 44600
        • Crea de Guadalajara
      • Monterrey, Mexico, 66460
        • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
      • México, Mexico, 06700
        • Clinstile, S.A. de C.V.
  • Poland
      • Krakow, Poland, 31-503
        • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
      • Lodz, Poland, 91-738
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Warsaw, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
  • Spain
      • Esplugues de Llobregat, Spain, 08950
        • Hospital Sant Joan De Deu
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnic La Fe
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
      • Izmir, Turkey (Türkiye), 35340
        • 9 Eylul University Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children
      • Liverpool, United Kingdom, L12 2AB
        • Alder Hey Children's Hospital
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital For Children NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7HE
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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