RecruitingNot ApplicableNCT06394063

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

Sponsor

RenJi Hospital

Enrollment

176 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria9

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.