A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Inclusion Criteria:

Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.

Moderate to severely active SLE is defined by the following:

1. Hybrid SELENA SLEDAI (hSLEDAI) total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points
2. BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
3. Clinical hSLEDAI score of ≥ 4 at Day 0 prior to randomization
4. At least one positive serologic parameter within the screening period
5. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

1. Active or unstable neuropsychiatric SLE or lupus nephritis
2. Autoimmune or rheumatic disease other than SLE
3. Significant, uncontrolled medical conditions not related to SLE
4. Active and/or severe viral, bacterial or fungal infection
5. History of malignancy within 5 years

Other protocol defined exclusion criteria may apply.