Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Inclusion Criteria:

1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997revised criteria for ≥ 24 weeks prior to signing the ICF

2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2Kscore ≥4 points at screening

3. BILAG2004 with at least 1 of the following:

4. BILAG2004 level A disease in ≥ 1 organ system

5. BILAG2004 level B disease in ≥ 2 organ systems

6. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening

7. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,

8. Must be on stable background standard therapy with DMARD, glucocorticoids oranti-malarials alone or in combinations.

Exclusion Criteria:

7. Active severe or unstable neuropsychiatric SLE

8. Active severe SLE-driven renal disease

9. History of any non-SLE disease that has required treatment with oral or parenteralcorticosteroids for more than a total of 2 weeks within the last 24 weeks prior tosigning the ICF.

10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3or more of the same type of infection over the previous 52 weeks).

11. Known history of a primary immunodeficiency, splenectomy, or any underlyingcondition that predisposes the patient to infection, or a positive result for humanimmunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.

12. At Screening, confirmed positive test for hepatitis B serology and positive test forhepatitis C antibody

13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),

14. Opportunistic infection requiring hospitalization or IV antimicrobial treatmentwithin 3 years of randomization.

15. History of cancer, apart from:

16. Squamous or basal cell carcinoma of the skin treated with documented success ofcurative therapy ≥ 3 months prior to Week 0 (Day 1)

17. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1year prior to Week 0 (Day 1).