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

NCT02725476 | Completed Phase 2 Results

• 1 other identifier: XmAb5871-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3

  Baseline Day 1 to Day 197

Study Arms (1)

XmAb5871

EXPERIMENTAL

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

Biological: XmAb5871

Interventions

XmAb5871 BIOLOGICAL

XmAb5871

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 38251576 DERIVED

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The fixed-dose group was added by amendment to collect information on fixed IV doses with bioequivalence to subcutaneous doses planned for future studies. This group is not intended for efficacy or safety comparisons to the initial 15 participants.

Results Point of Contact

• Title: Vice President, Biometrics
• Organization: Xencor, Inc.

bburington@xencor.com

858-480-3414

Study Officials

• John Stone, M.D., M.P.H.

  Rheumatology Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)