About the study

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.
2. Moderate to severely active SLE is defined by the following:
3. Hybrid SELENA SLEDAI (hSLEDAI) total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points
4. BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
5. Clinical hSLEDAI score of ≥ 4 at Day 0 prior to randomization
6. At least one positive serologic parameter within the screening period
7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
8. 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
6. Other protocol defined exclusion criteria may apply.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.