A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 159
- 主要终点
- Phase 1: safety and tolerability of SCTC21C
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus
详细描述
This study contains phase Ib and phase II studies. In phase Ib study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recomended dose of SCTC21C for the randomized dose optimation-stage. In phase 2 study, 2 dose levels will be uased. A total of 120 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 18-75 years;
- •Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
- •SELENA-SLEDAI ≥8 at screening;
- •Positive immunological markers within 12 months prior to baseline;
- •Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;
- •All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug
- •Understanding of the study procedures and voluntary signing of the informed consent form
排除标准
- •Severe active or unstable lupus-related neuropsychiatric disorders;
- •Combined with active infections, malignant tumors, or other autoimmune diseases;
- •Catastrophic antiphospholipid syndrome;
- •severe lupus nephritis;
- •Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;
- •Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
- •Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;
- •Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;
- •In accordance with the protocol requirements, participants with abnormal laboratory test results;
- •Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;
- •participants with a history of tuberculosis or latent tuberculosis infection;
- •Diagnosed with type 1 or type 2 diabetes with poor control;
- •Uncontrolled hypertension;
- •Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;
- •Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
- •History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study;
- •Pregnant or breastfeeding;
- •Any other condition that the investigator deems unsuitable for participation in the study
研究组 & 干预措施
experimental: SCTC21C
SCTC21C will be administered to participants for about 24 weeks
干预措施: SCTC21C (Biological)
结局指标
主要结局
Phase 1: safety and tolerability of SCTC21C
时间窗: From first dose to Week 48
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)
Phase II: efficacy of SCTC21C
时间窗: Up to Week 24
Percentage of participants who achiened an mSRI-4 response at W24
次要结局
- dose escalation part#SRI4/5/6/7/8(up to Week 48)
- Dose- escalation # mSRI4/5/6/7/8(up to Week 48)
- Dose-escalation part # BILAG(up to Week 48)
- Dose-escalation part # SLE flare(Up to Week 48)
- Dose-escalation part # immunogenicity(up to Week 48)
- Dose-escalation part # SCTC21C(up to Week 48)