NCT05680480招募中2 期
A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 45
- 主要终点
- Percentage of Participants with Complete Renal Response (CRR)
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 active lupus nephritis.
详细描述
This is a phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care (SOC) treatment in adult subjects with active proliferative lupus nephritis (LN).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-75 years of age, inclusive.
- •Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).
- •Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility.
- •Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study's central laboratory results.
- •Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.
- •Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when both HDCS and MMF have been started.
- •Able to understand the requirements of the study and provide written informed consent.
排除标准
- •Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
- •History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
- •Received any of the following therapies:
- •Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;
- •Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
- •Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
- •Received plasma separation or plasma exchange during the 6 weeks prior to screening;
- •Subjects who required dialysis within 1 year prior to screening.
- •Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
- •Received BCG Vaccine within 1 year prior to screening.
- •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).
- •History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
- •Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
- •Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
- •History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
- •Nursing or pregnant female, or male or female who prepared for parenthood during the study.
- •History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
- •Have acute or chronic infection requiring treatment.
- •HIV positive.
- •Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll.
- •Hepatitis C antibody positive.
- •History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.
- •eGFR<30 mL/min/1.73 m2 using CKD-EPI.
- •Renal biopsy showed 50% glomerulosclerosis.
- •Subjects who in the opinion of the investigator are not suitable to participate.
研究组 & 干预措施
Telitacicept 240 mg
Experimental
Telitacicept 240 mg given SC weekly plus standard therapy through week 48.
干预措施: Telitacicept 240 mg (Biological)
Telitacicept 160 mg
Experimental
Telitacicept 160 mg given SC weekly plus standard therapy through week 48.
干预措施: Telitacicept 160 mg (Biological)
Placebo
Placebo Comparator
Placebo given SC weekly plus standard therapy through week 48.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Complete Renal Response (CRR)
时间窗: Week 48
CRR is defined as estimated glomerular filtration rate (GFR) is no more than 20% below the baseline value or ≥ 60 mL/min/1.73m\^2 and 24-hour urinary protein: creatinine ratio ≤ 0.5 mg/mg and did not receive prohibited or rescue therapy resulting in treatment failure.
次要结局
- Percentage of participants with Partial Renal Response (PRR)(Week 24 and Week 48)
- Incidence of AE, SAE(Up to Week 48)
研究者
研究点 (45)
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