Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XmAb5871 · 2 trials · 2 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 |
| 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...
XmAb5871 is an investigational monoclonal antibody being studied for autoimmune conditions, specifically IgG4-related disease (IgG4-RD) and systemic lupus erythematosus (SLE). It is not yet approved for any indication and remains in clinical development.
XmAb5871 targets CD19, a protein found on the surface of B cells. By binding CD19, the antibody is designed to modulate B-cell activity, which is relevant in autoimmune diseases where B cells contribute to inflammation and tissue damage.
XmAb5871 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. Xencor specializes in engineered antibodies for cancer and autoimmune diseases.
XmAb5871 is in Phase 2 clinical development. It has completed Phase 2 trials in systemic lupus erythematosus and IgG4-related disease, but has not yet advanced to Phase 3 or received regulatory approval.
XmAb5871 has been evaluated in two completed Phase 2 trials: NCT02725515 in systemic lupus erythematosus (105 patients) and NCT02725476 in IgG4-related disease (20 patients). Both were conducted in the United States.