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

Primary Purpose

IgG4-RD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XmAb5871
Sponsored by
Xencor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgG4-RD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XmAb5871

Arm Description

XmAb5871 administered by IV infusion for up to a total of 12 infusions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2016
Last Updated
December 5, 2018
Sponsor
Xencor, Inc.
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02725476
Brief Title
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-RD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XmAb5871
Arm Type
Experimental
Arm Description
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Intervention Type
Biological
Intervention Name(s)
XmAb5871
Primary Outcome Measure Information:
Title
Proportion of Patients With an Improvement in IgG4-RD Activity
Description
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
Secondary Outcome Measure Information:
Title
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Stone, M.D., M.P.H.
Organizational Affiliation
Rheumatology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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