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Active, Not Recruiting

NCT Number: NCT04088396

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Systemic Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Body Temperature Changes Connective Tissue Diseases Fever Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto CAICI SRL, Rosario, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104

Tocilizumab

Drug

Administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24

    Time frame: Week 24

    Percentage of Participants Achieving Adapted PediACR30 Response Criteria

  2. Percentage of Participants with Inactive Disease

    Time frame: Week 12

    Percentage of Participants with Inactive Disease

  3. Percentage of Participants with Minimal Disease Activity

    Time frame: Week 12

    Percentage of Participants with Minimal Disease Activity

  4. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27

    Time frame: Baseline, Week 24

    Change from Baseline in JADAS-27

  5. 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

  6. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

    Time frame: Baseline through Week 24

    PK: Cmax, ss of Baricitinib

  7. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)

    Time frame: Baseline through Week 24

    PK: AUC, ss of Baricitinib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2019
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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