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

Launched by RENJI HOSPITAL · Apr 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called telitacicept to see if it can help prevent flare-ups in patients with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks healthy tissues. The trial is looking for adults aged 18 to 70 who have low disease activity, meaning their symptoms are relatively stable. Participants should have been on a consistent treatment plan for at least three months and will be randomly assigned to receive either telitacicept or a placebo (a dummy treatment with no active medication).

If you or a family member are interested in participating, it's important to know that certain health conditions may make someone ineligible, such as liver or kidney problems, recent cancer history, or active infections like HIV or COVID-19. Participants can expect to be closely monitored throughout the trial to ensure their safety. Overall, this study aims to find out if telitacicept can be a safe and effective way to help SLE patients avoid worsening symptoms.

Gender

ALL

Eligibility criteria

• 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.