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.
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 156 weeks
Part 1: Maximum observed plasma concentration (Cmax)
Timeframe: Day 7
Part 1: Time to maximum observed plasma concentration (Tmax)
Timeframe: Day 7
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
Timeframe: Day 7
Part 1: Apparent oral clearance at steady state (CL/F)
Timeframe: Day 7
Part 1: Half-life
Timeframe: Day 7