Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
Recruiting · NCT06394063 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTelitacicept
What this trial is about
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 can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-70 years;
- 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;
- 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;
- Sign the informed consent.
Exclusion criteria
- Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min;
- Exposure to cyclophosphamide within past 6 months before screening;
- Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
- Pregnant women, lactating women;
- 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;
- Active hepatitis or a history of severe liver disease;
- Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
- A significant decrease in immunoglobulin level, IgG\<5g/L;
- Not suitable for the study in the opinion of the investigator.
Where it is running
1 location listed.
- Ren Ji Hospital - Shanghai, China