Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects with Active Proliferative Lupus Nephritis - TULIP-LN1

Exclusion Criteria

• 1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
• 2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
• 3. Known intolerance to ≤1.0 gm/day of MMF
• 4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment
• 5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
• (a) Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
• (b) Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or
• (c) IV cyclophosphamide >2 pulses of high-dose (≥0.5 gm/m2) or >4 doses of low dose (500 mg every 2 weeks) or
• (d) Average MMF >2.5 gm/day (>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
• (e) Tacrolimus >4 mg/day for more than 8 weeks
• 6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
• 7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
• 8. Confirmed positive test for hepatitis B or hepatitis C
• 9. Any severe herpes infection at any time prior to randomization
• 10.Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason).
• 11. History of cancer, apart from:
• a. Squamous or basal cell carcinoma of the skin that has been successfully treated
• b. Cervical cancer in situ that has been successfully treated
• 12. Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is
• longer.
• 13. During screening (within 30 days before Day 1 [Week 0 visit]), any of the following:
• (a) Aspartate transaminase (AST) >2.5×upper limit of normal (ULN)
• (b) Alanine transaminase (ALT) >2.5×ULN
• (c) Total bilirubin >ULN (unless due to Gilbert's syndrome [based on Investigator’s judgement])
• (d) Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only)
• (e) Neutrophil count <1x103/μL (or <1.0 GI/L)
• (f) Platelet count <25x103/μL (or <25 GI/L)
• (g) Haemoglobin <8 g/dL (or <80 g/L).