A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Public ClinicalTrials.gov record NCT03725007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Participants \<18 years of age who are ongoing in Parts 2 and 3 will participate in an 104 week open-label extension of the study in Part 4.
Study identification
- NCT ID
- NCT03725007
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2019
- Primary completion
- Nov 30, 2028
- Completion
- Feb 28, 2029
- Last update posted
- Aug 2, 2026
2019 – 2029
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 211162 | Chicago | Illinois | 60611 | — |
| Duplicate_University of Louisville /ID# 202896 | Louisville | Kentucky | 40202 | — |
| Boston Children's Hospital /ID# 202993 | Boston | Massachusetts | 02115 | — |
| Cincinnati Childrens Hospital Medical Center /ID# 209697 | Cincinnati | Ohio | 45229 | — |
| Randall Children's Hospital /ID# 213609 | Portland | Oregon | 97227-1654 | — |
| The Children's Hospital of Philadelphia /ID# 209617 | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC /ID# 202994 | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Seattle Children's Hospital /ID# 203003 | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03725007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2026 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03725007 live on ClinicalTrials.gov.