A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

Trial Profile

A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

Discontinued
Phase of Trial: Phase II

Latest Information Update: 17 Apr 2018

At a glance

  • Drugs PTG 100 (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms PROPEL
  • Sponsors Protagonist Therapeutics
  • Most Recent Events

    • 26 Mar 2018 According to a Protagonist Therapeutics media release, this study has been discontinued, based on the interim analysis (n=65) of the primary endpoint of clinical remission by an independent Data Monitoring Committee (DMC). The DMC deemed the trial to be futile.
    • 26 Mar 2018 Status changed from recruiting to discontinued, according to a Protagonist Therapeutics media release.
    • 07 Mar 2018 According to a Protagonist Therapeutics media release, an interim futility analysis will be performed in the first quarter of 2018, and final top-line results are anticipated in the fourth quarter of 2018.
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