A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Patients With Active 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
- 1
- 主要终点
- Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus.
详细描述
Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient voluntarily participates in this study after full informed consent.
- •The age is 18 years ≤ age ≤ 70 years, regardless of gender.
- •Diagnosed with Systemic Lupus Erythematosus (SLE) at least ≥ 24 weeks prior to screening.
- •SLEDAI-2K total score ≥
- •On stable treatment for systemic lupus erythematosus at least 4 weeks prior to randomization, and should remain at a stable dose throughout the trial period.
排除标准
- •History of infection as defined in the protocol.
- •Any of the medical diseases or disorders listed in the protocol.
- •Significant, uncontrolled or unstable disease in any organ.
研究组 & 干预措施
Group A: D-2570 and placebo
干预措施: D-2570 (Drug)
Group A: D-2570 and placebo
干预措施: D-2570 Placebo (Drug)
Group B: D-2570 and placebo
干预措施: D-2570 (Drug)
Group B: D-2570 and placebo
干预措施: D-2570 Placebo (Drug)
Group C: D-2570
干预措施: D-2570 (Drug)
Placebo Control Group
干预措施: D-2570 Placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
时间窗: Week 32
次要结局
- Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48(Weeks 44-48)
- Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48(Weeks 4, 12, 24, and 48)
- Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48(Weeks 4, 12, 24, and 48)
- Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48(Weeks 4, 12, 24, 32, and 48)
- Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48(Weeks 44-48)
- Changes from baseline of anti-double-stranded DNA (dsDNA) antibody(From enrollment to the end of treatment at 48 weeks)
- blood drug concentration of D-2570(From enrollment to the end of treatment at 48 weeks)
- Incidence of adverse events rate based on NCI CTCAE V5.0(From enrollment to 52 weeks)
- Changes from baseline of complement (C3) levels(From enrollment to the end of treatment at 48 weeks)
- Changes from baseline of complement C4 levels(From enrollment to the end of treatment at 48 weeks)