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A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

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Trial Profile

A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Upadacitinib
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms U-ASTOUND
  • Sponsors AbbVie

    • Most Recent Events

    • 06 Dec 2024 Planned End Date changed from 31 Oct 2033 to 1 Oct 2033.
    • 06 Dec 2024 Planned primary completion date changed from 12 Aug 2028 to 1 Aug 2028.
    • 09 Oct 2023 Status changed from not yet recruiting to recruiting.

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