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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02725476
• Date of registration: 04/03/2016
• Prospective Registration: No
• Primary sponsor: Xencor, Inc.
• Public title: Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
• Scientific title: An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease
• Date of first enrolment: March 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02725476
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: John Stone, M.D., M.P.H.
• Affiliation: Rheumatology Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

IgG4-RD

Intervention(s)

Biological: XmAb5871

Primary Outcome(s)

Proportion of Patients With an Improvement in IgG4-RD Activity [Time Frame: Baseline Day 1 to Day 169]

Secondary Outcome(s)

Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3 [Time Frame: Baseline Day 1 to Day 197]

Secondary ID(s)

XmAb5871-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Massachusetts General Hospital

Results

• Results available: Yes
• Date Posted: 07/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02725476