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A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection

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Trial Profile

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs RBX 2660 (Primary)
  • Indications Clostridium difficile infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PUNCHCD3
  • Sponsors Rebiotix

Most Recent Events

  • 05 May 2025 According to a Ferring Pharmaceuticals media release, data from the trial were presented at at Digestive Disease Week 2025 (DDW2025) from May 3-6 in San Diego, CA.
  • 05 May 2025 Results presented in the Ferring Pharmaceuticals Media Release
  • 06 Mar 2025 According to a Ferring Pharmaceuticals media release, Health Canada has issued a Notice of Compliance, approving REBYOTA (fecal microbiota, live), a novel first-in-class microbiome-restoration therapy indicated for the prevention of recurrence of Clostridioides difficile infection (C. diff) in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff based on results form PUNCH-CD clinical program including Phase 3 PUNCH CD3 trial.

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