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A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

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

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Risankizumab (Primary) ; Risankizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms COMMAND
  • Sponsors AbbVie
  • 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.
    • 17 May 2024 According to AbbVie Media Release, data from this trial will be presented at the 2024 Digestive Disease Week (DDW) Annual Meeting, being held May 18-21 in Washington, D.C.
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