A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SG301 SC Injection in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 47
- 主要终点
- Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
研究概览
简要总结
This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .
详细描述
This was a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective was to evaluate the efficacy of SG301 SC Injection in participants with systemic lupus erythematosus (SLE) as assessed by the SRI-4 score. The secondary objectives included assessing the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants.
Eligible participants were those diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria, with a Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K )score of ≥ 8 points and seropositivity for antinuclear antibody (ANA) or anti-double-stranded DNA (anti-dsDNA) antibody at the screening visit.
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
- Triple (Participant, 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
- •Voluntarily participate in the clinical study and sign a written informed consent form.
- •Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease.
- •SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points.
- •Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity.
- •Body weight ≥ 35 kg.
- •Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose.
- •Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose.
排除标准
- •Previous use of CD38 or monoclonal antibodies targeting CD
- •Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol.
- •Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis.
- •Laboratory abnormalities.
- •Current acute or chronic infection meeting any of the following criteria.
- •Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided informed consent but did not receive trial treatment, or only received placebo).
- •Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose.
- •Receipt of any B cell-depleting drugs (such as belimumab, telitacicept) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
- •Receipt of JAK inhibitor treatment within 2 weeks before the first dose.
- •Presence of severe cardiovascular and cerebrovascular diseases.
- •Mycobacterium tuberculosis infection.
- •Presence of HIV infection, active hepatitis B, or hepatitis C.
- •Known history of active syphilis.
- •History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation.
- •Other conditions that the investigator believes would prevent the participant from participating in the study.
研究组 & 干预措施
SG301 SC - A
SG301 SC Injection
干预措施: SG301 SC Injection (Drug)
SG301 SC -B
SG301 SC Injection
干预措施: SG301 SC Injection (Drug)
Placebo
SG301 SC Placebo
干预措施: SG301 SC placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
时间窗: From baseline to week 25
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points; * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline; * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline;
次要结局
未报告次要终点