Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
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ClinicalTrials.gov Identifier: NCT02725476 |
Recruitment Status :
Completed
First Posted : April 1, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IgG4-RD | Biological: XmAb5871 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: XmAb5871
XmAb5871 administered by IV infusion for up to a total of 12 infusions
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Biological: XmAb5871 |
- 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. 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.
- 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.
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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725476
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | John Stone, M.D., M.P.H. | Rheumatology Clinic |
Documents provided by Xencor, Inc.:
Responsible Party: | Xencor, Inc. |
ClinicalTrials.gov Identifier: | NCT02725476 |
Other Study ID Numbers: |
XmAb5871-03 |
First Posted: | April 1, 2016 Key Record Dates |
Results First Posted: | December 7, 2018 |
Last Update Posted: | December 7, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Immunoglobulin G4-Related Disease Autoimmune Diseases Immune System Diseases |