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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05466890 | Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC) | PHASE2 | ACTIVE NOT_RECRUITING | 16 | — | — | Sep 15, 2022 | Mar 31, 2025 | Mar 5, 2025 | 14 | United States |
Adverse events (AEs) will be collected from the time of signing the informed consent form (ICF). All subjects who are randomized will be monitored for AEs until the time they leave the study.
Efficacy will be determined through the use of the Mayo Endoscopic Subscore.
| Arm | Type | Description |
|---|---|---|
| PL8177 | EXPERIMENTAL | PL8177 will be given orally and daily from baseline until end of study. |
| Placebo | PLACEBO_COMPARATOR | Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177. |
| Name | Type | Description |
|---|---|---|
| PL8177 Placebo | DRUG | Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177. |
| PL8177 | DRUG | Approximately 3/4 of randomized patients will receive active PL8177. |
Inclusion Criteria: * Age ≥18 to ≤75 years of age at Screening. * Has a history of UC diagnosis prior to screening; confirmed by endoscopic and histologic evidence in the subject chart. If the historical evidence is not available, then endoscopic and histologic evidence can be confirmed during the ...