A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 20
- 主要终点
- Proportion of LLDAS in week 24
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .
详细描述
This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria
- •18-65 years of age
- •body weight 45-90kg
- •antinuclear antibody titers ≥1:80, and/ or anti-double-stranded DNA antibodies
- •SLEDAI-2K score ≥8 scores
- •Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline)
- •A stantard therapy for at least 30d for patients who are not treatment-naive
- •Negative pregnancy test for child-bearing women at screening and baseline
- •Provide written informed consent
排除标准
- •Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
- •Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
- •severe lupus nephritis: 24hUP more than 6g, serum creatinine > 221umol/L
- •History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1)
- •Abnormal liver function (ALT or AST is 2 times higher than normal)
- •Baseline IgG below the lower limit of the normal range
- •Pregnancy or breastfeeding women
- •Have a history of malignant tumors
- •Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
- •Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV
- •Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics
- •Active hemorrhage or peptic ulcer
- •With other concommitant autoimmune disease;
- •Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization
- •Receipt of IVIG within 28 days before randomization
- •Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization
- •Participated in other drugs clinical trials within 4 weeks.
- •Receipt of live vaccine within 4 weeks before randomization
- •Receipt of COVID-19 vaccine within 4 weeks before randomization
- •Subjects who in the opinion of the investigator are not suitable to participate
研究组 & 干预措施
Treatment group
Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
干预措施: Telitacicept (Drug)
Treatment group
Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
干预措施: Standard of Care (Drug)
Control group
Standard of care
干预措施: Standard of Care (Drug)
结局指标
主要结局
Proportion of LLDAS in week 24
时间窗: week 24
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
次要结局
- Improvement in SLEDAI-2K(week 24 and 52)
- Number of participants with Adverse Events(up to week 52)
- Disease flare(up to week 52)
- Change in PGA(week 24, 52)
- Proportion of LLDAS in week 12(week 12)
- Improvement in serological indices(week 24, 52)
研究者
Xiaomei Leng
Principal Investigator, Clinical Professor
Peking Union Medical College Hospital