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Phase 3 double-blind, randomized, placebo-controlled trial of Omilancor in patients with mild-to-moderately active Ulcerative Colitis

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Trial Profile

Phase 3 double-blind, randomized, placebo-controlled trial of Omilancor in patients with mild-to-moderately active Ulcerative Colitis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2023

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At a glance

  • Drugs Omilancor (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms PACIFY II
  • Sponsors Landos Biopharma

    • Most Recent Events

    • 17 May 2023 According to NImmune Biopharma media release, company expects to dose the first patient in the global pivotal Phase 3 PACIFY program by years end.
    • 17 May 2023 According to NImmune Biopharma media release, PACIFY is a global registration directed double-blind randomized placebo-controlled Phase 3 program of omilancor in active UC patients ranging from mild to severe that aims to enroll 1,378 patients across 250 global clinical sites
    • 17 May 2023 According to NImmune Biopharma media release, attainment of either endpoint can serve as a basis for a New Drug Application (NDA).
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