NCT05796206进行中（未招募）2 期
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Part A and Part B:Percentage of participants achieving SRI-4 at Week 12
研究概览
简要总结
This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 ;
- •Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
- •Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
- •Low C3 and/or low C4 complement at screening ;
- •High disease activity at screening ;
- •On a stable SLE treatment regimen for at least 30 days prior to the first administration；
- •Able and willing to provide written informed consent and to comply with the study protocol.
排除标准
- •Unsufficient organ function;
- •Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- •Subjects with CD4+ T lymphocyte count < 200 cells/μL;
- •Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;
- •Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 12 weeks prior to the first administration; TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;
- •Received live or attenuated vaccination within 28 days prior to the first administration;
- •Participated in other clinical trials within 28 days prior to the first administration;
- •Concomitant with other serious diseases;
- •Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);
- •Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62 ;
- •Breastfeeding or pregnant women;
- •Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
- •Other conditions unsuitable for participation in this study determined by the Investigator.
研究组 & 干预措施
MIL62(Part A and B)
Experimental
干预措施: MIL62 (Drug)
Placebo (Part A and B)
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Part A and Part B:Percentage of participants achieving SRI-4 at Week 12
时间窗: at Week 12
次要结局
- Part A: Pharmacokinetic(PK) Parameters:Cmax(up to 76 weeks after randomization)
- Part A and Part B:Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52(from Week 40 to Week 52 after randomization)
- Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 24, 52, 76(up to 76 weeks after randomization)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week 52(at Week 52)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week 24(at Week 24)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week76(at Week 76)
- Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76(up to 76 weeks after randomization)
- Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM(up to 76 weeks after randomization)
- Part A and Part B:Percentage of Participants with Adverse Events(up to 76 weeks after randomization)
- Part A: Pharmacokinetic(PK) Parameters: AUC(up to 76 weeks after randomization)
- Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)(up to 76 weeks after randomization)
- Part Aand Part B: Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62(up to 76 weeks after randomization)
- Part A and Part B: Pharmacodynamics(PD) characteristics：summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells, CD3⁺CD4⁺ T cells, CD3⁺CD8⁺ T cells, NK cells, CD19⁺CD27⁺ B cells, and CD19⁺CD27- naïve B cells(up to 76 weeks after randomization)
研究者
研究点 (1)
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