A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus (ALLEGORY)

Prior treatment

• Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
• Intolerance or contraindication to study therapies

Other illness

• Presence of significant lupus-associated renal disease and/or renal impairment
• Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
• Known active infection of any kind or recent major episode of infection

Other

• Pregnancy or breastfeeding

• Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria ≥12 weeks prior to screening
• Anti-nuclear antibody (ANA) ≥1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
• Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening Low C3 is required in the presence of known genetic deficiency of C4
• High disease activity at screening, based on; British Isles Lupus Assessment Group (BILAG-2004) (Category A disease in ≥1 organ system and/or Category B disease in ≥2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score ≥8) and Physician’s Global Assessment (PGA) (score ≥1.0 on a 0 to 3 visual analogue scale [VAS])
• High disease activity on Day 1, based on; SLEDAI-2K (score ≥8) and PGA (score ≥1.0 on a 0 to 3 VAS)
• Current receipt of ≥1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants