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

Study Overview

• Status: Completed
• Conditions: IgG4-RD
• Intervention / Treatment: Biological: XmAb5871

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XmAb5871; XmAb5871 administered by IV infusion for up to a total of 12 infusions	Biological: XmAb5871

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline Day 1 to Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline Day 1 to Day 197

Collaborators and Investigators

• Sponsor: Xencor, Inc.
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: John Stone, M.D., M.P.H., Rheumatology Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Immunoglobulin G4-Related Disease
• Other Study ID Numbers: XmAb5871-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No