NCT04527380

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis \[JoAS\]) and juvenile psoriatic arthritis (JPsA).

Conditions

• Juvenile Psoriatic Arthritis
• Enthesitis Related Arthritis

Interventions

Type	Name	Description
DRUG	Ixekizumab	Administered SC
DRUG	Adalimumab	Administered SC

Timeline

• Start date: 2021-04-13
• Primary completion: 2024-02-19
• Completion: 2028-04-01
• First posted: 2020-08-26
• Last updated: 2026-03-19
• Results posted: 2025-06-05

Locations

43 sites across 12 countries: Argentina, Belgium, Czechia, Denmark, France, Germany, Italy, Mexico, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study