Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients

Summary

This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Eligibility

Inclusion Criteria:

1. Age 18-70 years;
2. SLE patients with low disease activity (SELENA-SLEDAI score\< 8 at screening ); disease duration more than 3 months；no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
3. A stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months;
4. Sign the informed consent.

Exclusion Criteria:

1. Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min;
2. Exposure to cyclophosphamide within past 6 months before screening;
3. Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
4. Pregnant women, lactating women;
5. History of Malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix;
6. Active hepatitis or a history of severe liver disease;
7. Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
8. A significant decrease in immunoglobulin level, IgG\<5g/L;
9. Not suitable for the study in the opinion of the investigator.

Conditions2

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