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A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2022

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At a glance

  • Drugs Ontamalimab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms FIGARO UC 301
  • Sponsors Shire; Shire Human Genetic Therapies; Takeda
  • Most Recent Events

    • 27 Oct 2021 Results assessing the clinical remission threshold for the UC e-diary using data from 2 Phase 3 trials (NCT03259334 and NCT03259308) of patients with ulcerative colitis, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021.
    • 27 Oct 2021 Results assess the psychometric properties of the UC e-diary in Adult patients with moderate-to-severe ulcerative colitis from NCT03259334 and NCT03259308, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021
    • 12 Aug 2021 This trial has been completed in Italy, according to European Clinical Trials Database record.
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