Phase III study to assess the safety and efficacy of Upadacitinib in study participants with moderate to severe active systemic lupus erythematosus (SLE)

Kriterien zur Teilnahme
- Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening according to the definition of the SLE classification criteria of the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 - Meet at least one of the following criteria at screening: 1- Positive antinuclear antibodies (ANA) 2- Positive anti-double-stranded DNA (dsDNA) 3- Positive anti-Smith - hSLEDAI (hybrid systemic lupus erythematosus disease activity index) >= 6, with >= 4 points being clinical (not based on laboratory criteria), independently determined at screening. The clinical hSLEDAI score (not based on laboratory criteria) must be confirmed at the baseline visit as >= 4. Lupus headaches or organic brain syndrome do not count towards the hSLEDAI points required for participation, but should be documented on the hSLEDAI if present. - Physician's global assessment (PhGA) >= 1 in the screening phase - Stable background therapy for >= 30 days prior to baseline (except for oral corticosteroids, which must have a stable dose for at least 14 days prior to baseline) with: a) Antimalarial drug(s) (Hydroxychloroquine <= 400 mg once daily, Chloroquine <= 500 mg once daily, Quinacrine <= 100 mg once daily) and/or Prednisone (or prednisone equivalent) (<= 20 mg once daily) and/or at most one of the following medications: Azathioprine (<= 150 mg once daily) b) Mycophenolate mofetil (<= 2 g once daily), Mycophenolate sodium <= 1,440 mg once daily c) Leflunomide (<= 20 mg once daily) d) Cyclosporine, Tacrolimus, Voclosporin (<= 23.7 mg twice daily) e) Methotrexate (<= 25 mg once weekly) or Mizoribine (<= 150 mg once daily) (BASEC)

Ausschlusskriterien
- Clinically relevant or significant abnormalities on ECG at screening. - Planned elective procedure that would affect study procedures or assessments until completion of assessments at Week 52. (BASEC)