A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)

Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2017

At a glance

  • Drugs Actoxumab/bezlotoxumab (Primary) ; Bezlotoxumab (Primary)
  • Indications Clostridium infections; Diarrhoea
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MODIFY II
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 09 May 2017 Results of post hoc analysis using the subset of Inflammatory Bowel Disease (IBD, n=1554) patients enrolled in the MODIFY trials (I and II), presented at the Digestive Disease Week 2017.
    • 09 May 2017 Results of pooled analysis (n=1526) using data from the Modify trials (I/II) assessing clinical cure and Clostridium Difficile Infection recurrence (rCDI) (12 weeks) in subgroups of patients, presented at the Digestive Disease Week 2017.
    • 25 Apr 2017 Results of pooled analysis of data from the MODIFY trials (n=1526), presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases.
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