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An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

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Trial Profile

An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Upadacitinib (Primary) ; Upadacitinib (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms SELECT-YOUTH
  • Sponsors AbbVie; AbbVie Germany

    • Most Recent Events

    • 14 Jun 2023 Planned primary completion date changed from 14 Feb 2027 to 17 Aug 2027.
    • 03 Jun 2023 Interim Results (cutoff date of 22 September 2022; n=57) evaluating all available safety data in parts 1, 2, and 3; efficacy was evaluated in parts 1 and 2 through week 12, presented at the 24th Annual Congress of the European League Against Rheumatism
    • 03 Jun 2023 Results (N = 51) assessing pharmacokinetics of upadacitinib in pediatric patients with polyarticular course juvenile idiopathic arthritis presented at the 24th Annual Congress of the European League Against Rheumatism
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