Tests telitacicept to help prevent lupus flares in people with mild lupus
Tests low-dose telitacicept against placebo in adults with lupus and low disease activity.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06394063, who can take part
Where in China
- Ren Ji HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT06394063
- Record updated
- 3 July 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; GFR < 60ml/min; Pregnant women, lactating women; A significant decrease in immunoglobulin level, IgG<5g/L; Not suitable for the study in the opinion of the investigator.