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
About this trial
This is an interventional treatment trial for IgG4-RD
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
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
NCT ID
NCT02725476
First Posted
March 4, 2016
Last Updated
December 5, 2018
Sponsor
Xencor, Inc.
Collaborators
Massachusetts General Hospital
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
Learn more about this trial
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
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