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

Study Identifier
M15-340
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Juvenile Idiopathic Arthritis
  • Study Drug
  • Upadacitinib
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    2 - 17 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
    Location
    Duplicate_University of Louisville /ID# 202896
    Louisville, Kentucky, United States, 40202
    Status
    Not applicable
    Location
    Boston Children's Hospital /ID# 202993
    Boston, Massachusetts, United States, 02115
    Status
    Not applicable
    Location
    Cincinnati Childrens Hospital Medical Center /ID# 209697
    Cincinnati, Ohio, United States, 45229
    Status
    Not applicable
    Location
    Randall Children's Hospital /ID# 213609
    Portland, Oregon, United States, 97227-1654
    Status
    Not applicable
    Location
    Children's Hospital of Philadelphia /ID# 209617
    Philadelphia, Pennsylvania, United States, 19146-2305
    Status
    Not applicable
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