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Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 29 Jan 2024

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At a glance

  • Drugs Filgotinib (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SELECTION; SELECTION1
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 05 Jan 2024 Results by deriving individual patient data from this study to conduct matching-adjusted indirect comparisons of clinical outcomes with filgotinib vs recently approved comparators (vedolizumab, tofacitinib, ustekinumab) in patients with moderately to severely active ulcerative colitis , published in the Inflammatory Bowel Diseases
    • 17 Oct 2023 Results of post hoc analysis evaluating individual Inflammatory Bowel Disease Questionnaire (IBDQ) item data from this study to assess which items drive the benefits of FIL treatment, presented at the 31st United European Gastroenterology Week
    • 17 Oct 2023 Results of a post-hoc analysis assessing prolonged benefit of Filgotinib treatment from week 10 (W10) until W58 presented at the 31st United European Gastroenterology Week

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