Using telitacicept to prevent flares in lupus patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of low-dose telitacicept in preventing flares among patients with systemic lupus erythematosus (SLE) who have low disease activity. The study focuses on patients who have been stable on a fixed treatment regimen for at least three months and have a SELENA-SLEDAI score of less than 8. By administering telitacicept, a dual-target inhibitor, the trial seeks to determine if it can effectively maintain low disease activity and prevent flare-ups in SLE patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ren Ji Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Ting Li
• Email: leeting007@163.com
• Phone: +8613916927066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.