A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

Trial Profile

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

Completed
Phase of Trial: Phase I

Latest Information Update: 07 Feb 2017

At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Millennium
  • Most Recent Events

    • 07 Feb 2017 Pooled results assessing pregnancy outcomes from six clinical studies and post marketing safety data published in the Alimentary Pharmacology and Therapeutics.
    • 24 Apr 2014 Primary endpoint 'Immunological-response-rate' has been met.
    • 24 Apr 2014 Results published in the Gut.
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