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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: Active Phase 1 study of Juvenile Idiopathic Arthritis (JIA), sponsored by AbbVie.

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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

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

FieldValue
Enrollment Target 124 participants
Start Date 2019-06-24
Est. Completion 2027-05
Phase Phase 1
AbbVie

526 total trials

What the registry record for NCT03725007 still lists

NCT03725007 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).

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 names 20 study sites across 16 states, led by 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.

Similar trials for Juvenile Idiopathic Arthritis (JIA)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03725007's enrollment target sits among peer trials

124 471st of 2000 higher than 1,526 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03725007, the US trial registry maintained by the National Library of Medicine. NCT03725007 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.