Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)

An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease

The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity

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
• Able and willing to complete the entire study according to the study schedule
• Able and willing to provide written informed consent

Exclusion Criteria:

• History or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
• Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy)
• Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening
• Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment
• Patient is taking >40 mg of prednisone QD
• Prior use of rituximab (or other B cell depleting agents) within 6 months of enrollment. Prior use of any B cell depleting agent greater than 6 months from enrollment is allowed if the CD19+ B cell count is within the normal reference range during screening
• Use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment
• Immunosuppressive agent use within the three months prior to enrollment
• Has received live vaccines within 2 months of enrollment
• Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to end-of-study visit
• Unable or unwilling to partake in the follow-up assessments or required protocol procedures