A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Inclusion Criteria

• •Participant has clinical diagnosis of Systemic Lupus Erythematosus (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 (SLE Disease Activity Index) ≥ 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 Principal Investigator (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 prior to 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.