A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02725515
• Date of registration: 08/01/2016
• Prospective Registration: Yes
• Primary sponsor: Xencor, Inc.
• Public title: A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
• Scientific title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
• Date of first enrolment: February 16, 2016
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02725515
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a diagnosis of SLE as defined by the ACR criteria

- Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented
within one year prior to randomization

- Investigator has assessed the patient and in their judgment, the SLE disease activity
is not organ threatening

- Both investigator and patient agree that it is acceptable to discontinue their current
immunosuppressant SLE medications and receive a brief course of IM steroid therapy

- If patients are on oral steroids, they must be on the equivalent of =15 mg/day of
prednisone to enter screening, and must be able to taper to =10 mg/day by
randomization

Exclusion Criteria:

- History or evidence of a clinically unstable/uncontrolled disorder, condition or
disease, other than SLE that, in the opinion of the investigator would pose a risk to
patient safety or interfere with the study evaluation, procedures or completion

- Patients who have organ threatening manifestations of SLE including active Class 3 or
4 lupus nephritis requiring induction or maintenance therapy or any other disorder for
which stopping SLE therapy is contraindicated

- Active CNS lupus such as seizures or psychosis that in the opinion of the investigator
would preclude participation

- Unstable hemolytic anemia or thrombocytopenia

- Patient is pregnant or breast feeding, or planning to become pregnant while
participating in the study

- Use of any biologic therapy (including belimumab) within 6 months of randomization, or
prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12
months of randomization



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: XmAb5871

Biological: Placebo to match XmAb5871

Primary Outcome(s)

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 [Time Frame: Day 225]

Secondary Outcome(s)

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 [Time Frame: Day 169]

Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients [Time Frame: From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.]

Secondary ID(s)

XmAb5871-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ICON plc

PPD

Results

• Results available: Yes
• Date Posted: 09/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02725515