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Combined Phase 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 Crohn's Disease

Trial Profile

Combined Phase 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 Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Filgotinib (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms Diversity1
  • Sponsors Galapagos NV; Gilead Sciences
  • Most Recent Events

    • 17 Oct 2023 Results assessing safety of FIL in Crohn's disease in DIVERSITY1 study and compared it with previously reported FIL safety data in ulcerative colitis from SELECTION study presented at the 31st United European Gastroenterology Week
    • 17 Oct 2023 Results of Efficacy and Safety of Filgotinib as Induction and Maintenance Therapy , presented at the 31st United European Gastroenterology Week
    • 03 Aug 2023 According to a Galapagos NV media release, based on the data from this study company decided not to submit a Marketing Authorization Application (MAA) in Europe for Crohn's disease (CD) and not to proceed with the MAA for filgotinib in UC in Switzerland.
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