A study to characterize the Pharmacokinetics, Pharmacodynamics, and Safety of anifrolumab in adult type I Interferon test high Systemic Lupus Erythematosus subject with active skin manifestations

Inclusion Criteria

• 1.Age 18 through 70 years
• 2. Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:
• -Positive antinuclear antibody (ANA) or
• -Elevated anti-dsDNA antibodies or
• -anti-Smith (anti-Sm) antibodies
• 3. Interferon high test result
• 4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10
• 5. Currently receiving at least 1 of the following for treatment of SLE:
• • Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization
• • Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization:
• (i) Azathioprine ≤200 mg/day
• (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine)
• (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
• (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week
• (v) Mizoribine ≤150 mg/day
• 6.Must not have signs of active or latent tuberculosis (TB).
• 7. Must not be pregnant or breastfeeding.