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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02725515 | A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus | PHASE2 | COMPLETED | 105 | — | — | Feb 16, 2016 | Jul 17, 2018 | Aug 20, 2019 | 23 | United States |
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225
| Arm | Type | Description |
|---|---|---|
| XmAb5871 | EXPERIMENTAL | XmAb5871 administered by IV infusion for up to a total of 16 infusions |
| Placebo | PLACEBO_COMPARATOR | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions |
| Name | Type | Description |
|---|---|---|
| XmAb5871 | BIOLOGICAL | - |
| Placebo to match XmAb5871 | BIOLOGICAL | - |
Inclusion Criteria: * Patients with a diagnosis of SLE as defined by the ACR criteria * Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization * Investigator has assessed the patient and in their judgment, the SLE disease activit...