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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04595825 | CM-101 in PSC Patients -The SPRING Study | PHASE2 | ACTIVE NOT_RECRUITING | 68 | — | — | Oct 1, 2020 | Sep 1, 2025 | Jan 9, 2024 | 33 | United States, Germany +3 |
Frequency and severity of treatment-emergent adverse events (TEAEs), including vital sign changes, changes in clinical safety laboratories and evaluation of infusion site reactions.
| Arm | Type | Description |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | EXPERIMENTAL | Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes) |
| Placebo | PLACEBO_COMPARATOR | Placebo - intravenous infusion |
| Name | Type | Description |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | BIOLOGICAL | Anti-human CCL24 monoclonal antibody (CM-101) 100 mg Intravenous Infusion over 60 minutes (±5 minutes) |
| Placebo | OTHER | Placebo - intravenous infusion |
Inclusion Criteria: * Subjects with diagnosis of large duct PSC of more than 24 weeks' duration * Subjects that have no significant clinical concern for cholangiocarcinoma based on clinical, laboratory or imaging findings * Subjects with serum Alkaline phosphatase (ALP) greater than 1.5 × Upper lim...