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RECRUITINGINTERVENTIONAL

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

A Randomized, Double-blind, Placebo-controlled Trial of Efficacy and Safety of Low-dose Telitacicept for Prevention of Flares in SLE Patients With Low Disease Activity

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

Telitacicept

Telitacicept 160 mg SC every other week

DRUG

Placebo

Placebo to Telitacicept

Locations (1)

Ren Ji Hospital
Shanghai, China