A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18 to 75
- •diagnosis of with SLE at least 6 months at screening visit
- •SLEDAE-2K≥5
- •Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
- •At least one SLE activity manifestation (as assessed by SLEDAE-2K)
排除标准
- •Failure to comply with the requirements of the programme
- •A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
- •Previously treated with a BTK inhibitor
- •Neuropsychiatric lupus (NPSLE)
- •Has other autoimmune diseases other than SLE
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Lower Dose
干预措施: ICP-022 (Drug)
Medium Dose
干预措施: ICP-022 (Drug)
Higher Dose
干预措施: ICP-022 (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant physical examination abnormalities
时间窗: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant laboratory examination abnormalities
时间窗: Up to 28 Days after the last dose of study drug
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
时间窗: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant vital signs abnormalities
时间窗: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant ECG abnormalities
时间窗: Up to 28 Days after the last dose of study drug
次要结局
- Serum Immunoglobulin (Ig) level(12 Weeks)
- Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)(12 Weeks)
- Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)(12 Weeks)
- Changes from Baseline in C4(12 Weeks)
- Changes from Baseline in Anti-nuclear Antibodies(12 Weeks)
- Occupancy rate of Bruton Tyrosine Kinase(BTK)(14 Days)
- Changes from Baseline in C3(12 Weeks)
- Changes from Baseline in serum dsDNA(12 Weeks)
- Changes from Baseline in Interferon-α(INF-α) level(12 Weeks)
- Changes from Baseline in Interleukin-6(IL-6) level(12 Weeks)
- Changes from Baseline in Ig levels(12 Weeks)
- Changes from Baseline in total B cell counts(12 Weeks)
- Change from Baseline in Beffs count(12 Weeks)
- Changes from baseline in Bregs count(12 Weeks)
- Changes from Baseline in Bregs to Beffs ratio(12 Weeks)
- Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)(12 Weeks)
- The plasma concentration-time curve(14 Days)