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

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Xencor

Status and phase

Completed
Phase 2

Conditions

IgG4-RD

Treatments

Biological: XmAb5871

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02725476
XmAb5871-03

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

XmAb5871
Experimental group
Description:
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Treatment:
Biological: XmAb5871

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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