IgG4-RD Clinical Trial
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
| Verified date | December 2018 |
| Source | Xencor, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Xencor, Inc. | Massachusetts General Hospital |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04918147 -
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
|
Phase 2 |