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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Percentage of patients with disease flares
研究概览
简要总结
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.
详细描述
Background: There are still two major problems in the treatment of SLE: flare and long-term organ damage. BLISS-52 showed there was some reduction of flare (80% vs 71%) in belimumab , but the difference was not significant. Another study tested the efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe SLE in which analysis of atacicept 150 mg suggested benefit.
Telitacicept , a BAFF/APRIL dual-target-inhibitor, which has been proved to be effective in treatment of SLE. But there is no study to show its effectiveness for prevention of flares in SLE patients with low disease activity. In this study, we take telitacicept as maintain treatment in stable SLE patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Telitacicept
Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.
干预措施: Telitacicept (Biological)
Placebo
Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with disease flares
时间窗: 52 weeks
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
次要结局
- Percentage of patients with mild/moderate flares(52 weeks)
- Percentage of patients with major flares(52 weeks)
- Prednisone dose at each visit(52 weeks)
- PGA score at each visit(52 weeks)
- SELENA-SLEDAI score at each visit(52 weeks)
- Maintenance time of LLDAS/Remission(52 weeks)
- Time to first disease flare(52 weeks)
- Number of participants with adverse events as assessed by CTCAE v5.0(52 weeks)