Male or female, ≥18 years of age at screening Females: non-childbearing potential or non-pregnant, non-lactating and agree to effective contraception use Males: surgically sterilised or agree to effective contraception use Diagnosis of SLE according to the American College of Rheumatology revised criteria Active SLE as demonstrated by a SLEDAI-2K score ≥6 at screening and a clinical SLEDAI-2K score ≥4 (with points for arthritis or rash) at screening and randomisation Moderate to severe rash or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous or musculoskeletal body system at screening and randomisation On prednisone (or prednisone equivalent) for ≥8 weeks before screening and on a stable dose of 7.5 to 30 mg of prednisone (or prednisone equivalent) for ≥4 weeks before screening Antimalarial/NSAID use: stable dose for ≥4 weeks before screening and throughout the study Methotrexate/azathioprine/mycophenolate mofetil use: stable dose for ≥8 weeks before screening and throughout the study
| History of sensitivity to ACTH preparations or porcine protein products Known contraindication(s) to RCI Unwilling to receive or intolerant of subcutaneous injections Severe active lupus nephritis* or required haemodialysis within 3 months before screening or likely to require haemodialysis in the study Active CNS manifestations of lupus within 3 months before screening or development of CNS lupus between screening and the first dose of study drug Received any steroid injection within 4 weeks before screening Received oral prednisone >30 mg/day or equivalent, ciclosporin or any non-biological investigational drug within 3 months before screening Received intravenous Ig or plasmapheresis within 4 months before screening Received cyclophosphamide, abatacept, B-cell-targeted therapy, B-cell-depleting therapy or any biological investigational agent within 6 months before screening Known immune compromised status (not related to SLE or SLE therapies)
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