Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Inclusion Criteria:

1. Active proliferative LN Class III or IV either with or without the presence of ClassV according to the 2003 ISN/RPS classification

2. Renal biopsy obtained within 6 months prior to signing the ICF or during ScreeningPeriod.

3. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)

4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease EpidemiologyCollaboration formula).

5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.

6. No signs of symptoms of active TB prior to or during screening or no treatment forlatent TB

Exclusion Criteria:

1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 monthsprior to signing the ICF or during Screening.

2. Known history of a primary immunodeficiency, splenectomy, or any underlyingcondition that predisposes the participant to infection, or a positive result forHIV confirmed by the central lab at Screening - an HIV test must be performed duringScreening, and the result should be available prior to Week 0 (Day 1).

3. Evidence of hepatitis C or active hepatitis B.

4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinomaand cervical cancer in situ.

5. Receipt of the following for the current LN flare (ie, since the qualifying renalbiopsy): IV cyclophosphamide > 2 pulses of high-dose (≥ 0.5 g/m2) or > 4 doses oflow dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day ofenteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/dayfor more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeksprior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeksprior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeksprior the ICF.

6. Previous receipt of >◦2 investigation treatments (other than anifrolumab) for LN orSLE since time of diagnosis and through the ICF.

7. Known intolerance to ≤ 1.0 g/day of MMF.

8. Any history of severe COVID-19 infection.