A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Profile

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 21 Mar 2017

At a glance

  • Drugs Andecaliximab (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 19 Jan 2017 This trial has been completed in Belgium (end date: 16 Nov 2016).
    • 06 Oct 2016 This trial was completed in Spain, according to Eudra record.
    • 21 Sep 2016 According to Gilead Sciences media release, the Data Monitoring Committee (DMC) decided to stop this trial following interim analysis of unblinded efficacy and safety data after the first 150 patients of a planned 1600-patient trial were treated for an 8-week induction duration due to meeting the pre-specified futility and efficacy criteria.
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