. 2020 Apr 21;7(1):e000383. doi: 10.1136/lupus-2020-000383

Table 1.

Key inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
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)

Inclusion criteria

Exclusion criteria

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)

*SCr >2.5 mg/dL or protein creatinine ratio >1.5 g/g.

ACTH, adrenocorticotropic hormone; BILAG-2004, British Isles Lupus Assessment Group-2004; CNS, central nervous system; Ig, immunoglobulin; NSAID, non-steroidal anti-inflammatory drug; RCI, repository corticotropin injection; SCr, serum creatinine; SLEDAI-2K, SLE Disease Activity Index-2000.