A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults

Trial Profile

A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults

Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

  • Drugs SER 109 (Primary)
  • Indications Clostridium infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ECOSPOR III
  • Sponsors Seres Therapeutics
  • Most Recent Events

    • 08 Nov 2017 According to a Seres Therapeutics media release, the study has obtained clinical trial application clearance from Health Canada, and Canadian clinical sites are expected to be opened in the coming weeks.
    • 03 Aug 2017 according to a Seres Therapeutics media release, the company expects that this single pivotal study may support SER-109 registration and approval, for this breakthrough therapy- and orphan drug- designated drug candidate.
    • 12 Jun 2017 The company expects that this single pivotal study may support SER-109 registration and approval, according to a Seres Therapeutics media release.
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