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

Starting soon · Phase 2

Conditions studied: Clostridium Difficile Infection Recurrence

In brief

Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).

Key facts

Study ID

NCT07513285

Run by

Acurx Pharmaceuticals Inc.

People needed

20

Starts

2026-08-19

Expected to finish

2027-11-24

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins
• Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.
• At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin

You may not qualify if…

• Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure < 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon
• Received more than 24 hours of dosing with antibiotics for the current CDI episode:
• Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks
• Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin [IVIG], bezlotoxumab
• Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms > 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.
• Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks.
• Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks
• Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
• Known current history of a severely compromised immune system

Full record on ClinicalTrials.gov

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