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An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

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Trial Profile

An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Takeda

    • Most Recent Events

    • 26 Feb 2025 Status changed from not yet recruiting to recruiting.
    • 17 Dec 2024 Planned initiation date changed from 30 Sep 2024 to 31 Jan 2025.
    • 11 Apr 2024 Planned initiation date changed from 29 Jul 2024 to 30 Sep 2024.

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