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

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505060-11-00

Acronym

M15-340

Enrollment

104

Registered

2023-08-31

Start date

2019-06-19

Completion date

Unknown

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyarticular Course Juvenile Idiopathic Arthritis

Brief summary

The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.

Detailed description

To evaluate the palatability of upadacitinib oral solution in pediatric subjects.

Interventions

DRUGUpadacitinib

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.	—

Secondary

Measure	Time frame
To evaluate the palatability of upadacitinib oral solution in pediatric subjects.	—

Countries

Germany, Hungary, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026