NCT03725007

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

Conditions

• Juvenile Idiopathic Arthritis (JIA)

Interventions

Type	Name	Description
DRUG	Upadacitinib	Upadacitinib is administered as an oral solution or tablet as described in protocol.

Timeline

• Start date: 2019-06-24
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2018-10-30
• Last updated: 2025-08-05

Locations

35 sites across 10 countries: United States, Canada, Germany, Hungary, Israel, Italy, Japan, Puerto Rico, Spain, Sweden

Regulatory

• FDA-regulated drug study