Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XmAb5871 · 3 trials · 3 indications
Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis.
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 12 infusions |
| Placebo | PLACEBO_COMPARATOR | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions |
| Cohort 1 | EXPERIMENTAL | Dose Level 1 XmAb5871 given SC Q14days X 3 |
| Cohort 2 | EXPERIMENTAL | Dose Level 2 XmAb5871 given SC Q14days X 3 |
| Cohort 3 | EXPERIMENTAL | Dose Level 3 XmAb5871 given SC Q14days X 3 |
| Cohort 4 | EXPERIMENTAL | Dose Level 4 XmAb5871 given IV Q14days X 3 |
| Cohort 5 | EXPERIMENTAL | Dose Level 5 XmAb5871 given SC Q7days X 3 |
| Name | Type | Description |
|---|---|---|
| XmAb5871 | BIOLOGICAL | - |
| Placebo to match XmAb5871 | BIOLOGICAL | - |
Inclusion Criteria: * Active IgG4-RD * Compatible pattern of organ involvement consistent with IgG4-RD that cannot be attributed to other causes * Histopathologically-proven diagnosis of IgG4-RD * Peripheral blood plasmablast count \>900 cells/mL and/or elevated IgG4-RD levels during screening * Ab...
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XmAb5871 is an investigational drug being studied for IgG4-related disease (IgG4-RD) and systemic lupus erythematosus (SLE). It has also been evaluated in healthy volunteers for bioavailability studies. The drug is currently in clinical development and is not approved by the FDA.
XmAb5871 is being developed by Xencor, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker XNCR. Xencor is conducting clinical trials to evaluate the drug's safety and efficacy in autoimmune conditions.
XmAb5871 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial assessed bioavailability in healthy volunteers, while Phase 2 trials evaluated the drug in patients with IgG4-related disease and systemic lupus erythematosus. All trials are completed, and the drug remains investigational.
XmAb5871 has been studied in three completed clinical trials. NCT02725476 evaluated the drug in patients with IgG4-related disease, NCT02725515 assessed its effect in systemic lupus erythematosus, and NCT02867098 was a bioavailability study in healthy volunteers. All trials were conducted in the United States.
XmAb5871 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial records. It is a small molecule developed by Xencor, Inc. for potential use in autoimmune diseases.