Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
- Conditions
- IgG4-RD
- Interventions
- Biological: XmAb5871
- Registration Number
- NCT02725476
- Lead Sponsor
- Xencor, Inc.
- Brief Summary
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XmAb5871 XmAb5871 XmAb5871 administered by IV infusion for up to a total of 12 infusions
- Primary Outcome Measures
Name Time Method Proportion of Patients With an Improvement in IgG4-RD Activity Baseline Day 1 to Day 169 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.
- Secondary Outcome Measures
Name Time Method Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3 Baseline Day 1 to Day 197 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States