Clinical trial NCT02725476: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: IgG4-RD
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2016-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion of Patients With an Improvement in IgG4-RD Activity
timeFrame: Baseline Day 1 to Day 169
Secondary outcomes:
measure: Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
timeFrame: Baseline Day 1 to Day 197
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Rheumatology Clinic
name: John Stone, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: