Ground Truth
Inclusion Criteria:Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.At Screening, must have at least one of the following:antinuclear antibody(ANA)+ (titer >= 1:80).anti-dsDNA+.anti-Smith+.SLEDAI-2K >= 6 despite background therapy as reported and independently adjudicated (clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at Screening.If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.If participant has rash and PI considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.Score must be re-confirmed at the Baseline visit.Physician's Global Assessment (PhGA) >= 1 during screening period.Must be on background treatment, stable for 30 days, at Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg), azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (<=20 mg).No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.Exclusion Criteria:Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.
Prediction
Inclusion Criteria: Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
At Screening, must have at least one of the following: antinuclear antibody (ANA)+ (titer ≥ 1:80).
anti-dsDNA+.
anti-Smith+.
SLEDAI-2K ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening.
If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
If participant has rash and PI considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
Score must be re-confirmed at the Baseline visit.
Physician’s Global Assessment (PhGA) ≥ 1 during screening period.
Must be on background treatment, stable for 30 days, at Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (< 20 mg), azathioprine (< 150 mg), mycophenolate (< 2 g), leflunomide (< 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (< 20 mg).
No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.
Exclusion Criteria: Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.