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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02725476
Recruitment Status : Completed
First Posted : April 1, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Massachusetts General Hospital
Information provided by (Responsible Party):
Xencor, Inc.

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

Condition or disease Intervention/treatment Phase
IgG4-RD Biological: XmAb5871 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: XmAb5871
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Biological: XmAb5871

Primary Outcome Measures :
  1. Proportion of Patients With an Improvement in IgG4-RD Activity [ Time Frame: 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 :
  1. Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02725476

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Xencor, Inc.
Massachusetts General Hospital
Principal Investigator: John Stone, M.D., M.P.H. Rheumatology Clinic
  Study Documents (Full-Text)

Documents provided by Xencor, Inc.:
Statistical Analysis Plan  [PDF] November 20, 2017
Study Protocol  [PDF] January 31, 2017

Responsible Party: Xencor, Inc. Identifier: NCT02725476     History of Changes
Other Study ID Numbers: XmAb5871-03
First Posted: April 1, 2016    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No