The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Massachusetts General Hospital
Boston, Massachusetts, United States
Proportion of Patients With an Improvement in IgG4-RD Activity
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.
Time frame: Baseline Day 1 to Day 169
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
The number of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 will be tabulated according to MedDRA system-organ class and preferred term, intensity and causality.
Time frame: Baseline Day 1 to Day 197
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