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

Phase 3

Recruiting

• Conditions: Systemic Juvenile Idiopathic Arthritis
• Interventions: Drug: Baricitinib; Drug: Tocilizumab

• Registration Number: NCT04088396
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2020-02-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-04
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 Baricitinib	Baricitinib	Baricitinib given orally.
Cohort 1 Tocilizumab	Tocilizumab	Tocilizumab given Subcutaneously (SC).
Cohort 2 Baricitinib	Baricitinib	Baricitinib given orally.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12	Week 12	Percentage of Participants Achieving Adapted PediACR30 Response Criteria

Secondary Outcome Measures

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

Trial Locations

Locations (58)

Instituto CAICI SRL; 🇦🇷 Rosario, Santa Fe, Argentina

Centro Medico Privado de Reumatologia; 🇦🇷 SAN M. DE Tucuman, Tucumán, Argentina

UZ Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Faculdade de Medicina da UNESP; 🇧🇷 Botucatu, São Paulo, Brazil

Instituto da Crianca do Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, São Paulo, Brazil

IPITEC; 🇧🇷 São Paulo, Brazil

Universidade Federal de Sao Paulo; 🇧🇷 São Paulo, Brazil

Detska nemocnice FN Brno; 🇨🇿 Brno, Brno-město, Czechia

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