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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02725476
Other study ID # XmAb5871-03
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date December 2017

Study information

Verified date December 2018
Source Xencor, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
XmAb5871


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Xencor, Inc. Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Terminated NCT04918147 - Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) Phase 2