NCT04088396

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

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Baricitinib	Administered orally
DRUG	Tocilizumab	Administered SC

Timeline

• Start date: 2020-02-12
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2019-09-12
• Last updated: 2026-02-10

Locations

55 sites across 14 countries: Argentina, Belgium, Brazil, Czechia, France, India, Israel, Italy, Japan, Mexico, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study