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ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

NCT03725007 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

AbbVie

603 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03725007 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, Pennsylvania, North Rhine-Westphalia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03725007?

The interventions under investigation include: Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03725007?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial