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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03183141 | ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection | PHASE3 | COMPLETED | 263 | — | — | Oct 23, 2017 | Apr 29, 2022 | Apr 10, 2023 | 107 | United States, Canada |
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
| Arm | Type | Description |
|---|---|---|
| SER-109 | EXPERIMENTAL | Received oral dose of SER-109 |
| Name | Type | Description |
|---|---|---|
| SER-109 | BIOLOGICAL | SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores |
Cohort 1 Main Inclusion Criteria: 1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of a treatment regimen of SER-109 or placebo 2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally author...