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

NCT ID: NCT02725476

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-12-31

Brief Summary

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

Conditions

IgG4-RD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XmAb5871

XmAb5871 administered by IV infusion for up to a total of 12 infusions

Group Type: EXPERIMENTAL

XmAb5871

Intervention Type: BIOLOGICAL

Interventions

XmAb5871

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Xencor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Stone, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Clinic

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Perugino CA, Wallace ZS, Zack DJ, Quinn SM, Poma A, Fernandes AD, Foster P, DeMattos S, Burington B, Liu H, Allard-Chamard H, Smith N, Kai X, Xing K, Pillai S, Stone JH. Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial. Lancet Rheumatol. 2023 Aug;5(8):e442-e450. doi: 10.1016/S2665-9913(23)00157-1. Epub 2023 Jul 24.

Reference Type: DERIVED

PMID: 38251576 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

XmAb5871-03

Identifier Type: -

Identifier Source: org_study_id