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NCT03725007 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
A Phase 1 study of Juvenile Idiopathic Arthritis (JIA), sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT03725007 is a Phase 1 study of Juvenile Idiopathic Arthritis (JIA) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 124 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT03725007, a Phase 1 study of Juvenile Idiopathic Arthritis (JIA), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Upadacitinib
Study Locations (20)
Other
- Helios Klinikum Berlin-Buch /ID# 206859 - Berlin
- Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571 - Hamburg
- Semmelweis Egyetem /ID# 208970 - Budapest
Pennsylvania
- Children's Hospital of Philadelphia /ID# 209617 - Philadelphia
- Children's Hospital of Pittsburgh of UPMC /ID# 202994 - Pittsburgh
North Rhine-Westphalia
- Asklepios Klinik Sankt Augustin /ID# 203264 - Sankt Augustin
- St. Josef-Stift Sendenhorst /ID# 244740 - Sendenhorst
Illinois
- Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162 - Chicago
Kentucky
- Duplicate_University of Louisville /ID# 202896 - Louisville
Massachusetts
- Boston Children's Hospital /ID# 202993 - Boston
Ohio
- Cincinnati Childrens Hospital Medical Center /ID# 209697 - Cincinnati
Oregon
- Randall Children's Hospital /ID# 213609 - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03725007
The ClinicalTrials.gov registry entry for NCT03725007 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Juvenile Idiopathic Arthritis (JIA) appearing as the primary indexed condition, and to 1 intervention - of which Upadacitinib is the first listed.
NCT03725007 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Pennsylvania, North Rhine-Westphalia.
Frequently Asked Questions
What is clinical trial NCT03725007 about?
NCT03725007 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis". 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. Participa...
What is the current status of trial NCT03725007?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2019-06-24. Estimated completion is 2027-05.
What conditions does trial NCT03725007 study?
This clinical trial studies the following conditions: Juvenile Idiopathic Arthritis (JIA).
What interventions are being tested in trial NCT03725007?
The interventions under investigation include: Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT03725007?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03725007 being conducted?
This trial has 20 study locations across Illinois, Kentucky, Massachusetts, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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