Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04247542 | ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection | PHASE2 | COMPLETED | 53 | — | — | Mar 6, 2020 | Nov 15, 2023 | Jan 17, 2025 | 29 | United States |
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.
| Arm | Type | Description |
|---|---|---|
| Ibezapolstat | EXPERIMENTAL | Active investigational antibacterial agent: ibezapolstat 450 mg po Q12H x 10 days |
| Vancomycin | ACTIVE_COMPARATOR | Standard of care: Vancomycin 125 mg po Q6H x 10 days |
| Name | Type | Description |
|---|---|---|
| Ibezapolstat | DRUG | Investigational antibacterial agent |
| Vancomycin | DRUG | Active comparator |
Inclusion Criteria: 1. Male or female 18 to 90 years of age, inclusive, at the time of Screening. 2. Capable of reading, understanding, and signing the written informed consent; able to adhere to all study procedures and attend all scheduled study visits. 3. Confirmed diagnosis of mild or moderate ...