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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Jun 2024

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At a glance

  • Drugs Risankizumab (Primary) ; Risankizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms INSPIRE
  • Sponsors AbbVie; AbbVie Germany

    • Most Recent Events

    • 18 Jun 2024 According to an AbbVie media release, company announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohns disease. Approval supported by two Phase 3 clinical trials, a 12-week induction study, INSPIRE and a 52-week maintenance study, COMMAND.
    • 31 May 2024 According to an AbbVie media release, the European Medicines Agencys (EMAs) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI) for the treatment of adults with moderately to severely active UC. The CHMP positive opinion is supported by data from two Phase 3 clinical trials: the INSPIRE induction trial and the COMMAND maintenance trial. The final European Commission decision is expected in the third quarter of 2024.
    • 22 Feb 2024 This trial has been completed in Portugal (Global end date: 11 May 2023) according to European Clinical Trials Database record.

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