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

NCT04088396 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-10

No results posted yet for this study

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

DRUG

Baricitinib

Administered orally

DRUG

Tocilizumab

Administered SC

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Argentina
  • Belgium
  • Brazil
  • Czechia
  • France
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088396 on ClinicalTrials.gov