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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06335979 | An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). | PHASE1 | RECRUITING | 54 | — | — | Oct 8, 2024 | Nov 17, 2027 | May 29, 2026 | 13 | Bulgaria, China +5 |
Safety assessments of PIT565 including changes in vital signs, electrocardiograms (ECG) and laboratory results from baseline
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Dose level 1 |
| Cohort 2 | EXPERIMENTAL | Dose level 2 |
| Cohort 3 | EXPERIMENTAL | Dose level 3 |
| Cohort 4 | EXPERIMENTAL | Dose level 4 |
| Cohort 5 | EXPERIMENTAL | Dose level 5 |
| Cohort 6 | EXPERIMENTAL | Dose level 6 |
| Cohort 7 | EXPERIMENTAL | Dose level 7 |
| Cohort 8 | EXPERIMENTAL | Dose level 8 |
| Name | Type | Description |
|---|---|---|
| PIT565 | DRUG | In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity. |
Inclusion Criteria: * Diagnosis of SLE according to the 2019 ACR/EULAR criteria * Documentation of SLE autoantibodies * Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening * Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol * Immun...