A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

Inclusion:

• Male or female, 18 - 65 years of age
• Must have at least one of the following: ANA+ (≥ 1:80), anti-dsDNA+, or anti-Smith+ Background tx, stable for 30 days at Baseline, with antimalarial(s), prednisone (≤ 20 mg), AZA (≤ 150 mg), CellCept (≤ 2 g), LEF (≤ 20 mg), cyclosporine, tacrolimus, and/or MTX (≤ 20 mg). The combination of background tx with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, add'l immunosuppressant is permitted.

Exclusion:

• Excl. active lupus nephritis (Class IV or >1g/d proteinuria) or have undergone induction therapy within the last 6 mos.
• Excl. a history of any malignancy except for successfully treated non-melanoma skin cancer or carcinoma in-situ of the cervix.
• Excl. any conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
• Excl. recipients of an organ transplant.
• No hx of clinically significant medical conditions or any other reason that in the opinion of PI would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
• Must not be using IV or IM corticosteroids ≥40 mg prednisone-equivalent bolus within 30 days of planned rand. Must not have been treated with IA, IM, IV, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 wks prior to the first dose of study drug.