Phase 2 Open-Label Study of Oral Ibezapolstat for Treating and Reducing Recurrence of Multiple Recurrent Clostridioides Difficile Infections in Adults

What this Trial Is About

Researchers are evaluating the safety, efficacy, and tolerability of ibezapolstat ACX-362E in adults with recurrent Clostridioides difficile infection CDI who have experienced three or more episodes within the past year. This Phase 2, open-label, single-arm study focuses on treatment and reducing CDI recurrence in this patient group. Participants will receive ibezapolstat 450 mg orally every 12 hours with food for 14 days, totaling 28 doses. Up to 20 participants will be treated and monitored through multiple follow-up points to assess clinical cure on Day 16, sustained clinical cure on Day 42, and CDI recurrence rates up to Week 24. Extended clinical cure will also be evaluated during this period. During the study, participants will be closely monitored for clinical response, recurrence of infection, and changes in the fecal microbiome. Researchers will assess time to diarrhea resolution and track safety and tolerability. Follow-up visits will continue through Week 24 to evaluate long-term outcomes and sustained treatment effects.

ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection