Systemic Lupus Erythematosus

The primary objective of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

A-623

A-623

Injection

100 mg/ml/vial

This is a long-term follow-up study to assess the safety of A-623. No formal inferential statistical analyses are planned. Descriptive statistics will be used to summarize the data.

Subjects are eligible for inclusion if they meet the following inclusion criteria:
1. Completed the treatment period specified in study AN-SLE3321

Subjects must NOT meet any of the following exclusion criteria:
1. Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures.
 This includes active significant infection, malignancy, and acutely life or organ-threatening manifestation of SLE (e.g., proliferative nephritis or unstable CNS lupus).
2. Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline (if the subject is a female of childbearing potential). Males who are intending to impregnate a female. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control during the study and for 3 months following completion of therapy. A reliable
method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom) or
vasectomy.
3. Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods:
 Cyclophosphamide or other alkylating agent – 3 months prior to screening
 Cyclosporine – 2 months prior to screening
 Anti-TNF alpha – 3 months prior to screening
 Transfusion, IV immunoglobulin, plasmapheresis or plasma exchange – 3 months prior to screening
 Live vaccines – 30 days prior to screening
4. Any prior administration of a B-cell modulating therapy (i.e., belimumab, TACI-Ig, epratuzumab, rituximab) other than A-623.
5. General
 Subject has known sensitivity to any of the products to be administered during dosing.
 Subject will not be available for follow-up assessment.