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Clinical Trials in China / NCT06394063
Recruiting Not applicable

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

NCT06394063 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2024-06-28
Last updated
2024-07-03

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

Telitacicept →Placebo

Telitacicept: Telitacicept 160 mg SC every other week

Placebo: Placebo to Telitacicept

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ren Ji Hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06394063 on ClinicalTrials.gov ↗ ← All trials in China