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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Xencor, Inc.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT02725476
First received: March 4, 2016
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity

Condition Intervention Phase
IgG4-RD
Biological: XmAb5871
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Xencor, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • Percent of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 [ Time Frame: Baseline Day 1 to Day 197 ]
    Percent 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.


Estimated Enrollment: 21
Actual Study Start Date: March 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XmAb5871
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Biological: XmAb5871

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02725476

Contacts
Contact: John Stone, M.D., M.P.H. 617-726-7938 JHSTONE@mgh.harvard.edu
Contact: Ana Fernandes 617-724-2792 adfernandes@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Xencor, Inc.
Massachusetts General Hospital
Investigators
Principal Investigator: John Stone, M.D., M.P.H. Rheumatology Clinic
  More Information

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02725476     History of Changes
Other Study ID Numbers: XmAb5871-03
Study First Received: March 4, 2016
Last Updated: April 21, 2017
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on April 27, 2017