A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline
研究概览
简要总结
Primary Objective:
Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo.
Secondary Objectives:
Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability and safety of SAR113244.
Assess in male and female lupus patients:
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The pharmacokinetics of SAR113244.
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The pharmacodynamics of SAR113244 for the following disease parameters:
-
Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte sedimentation rate and C-reactive protein.
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Peripheral blood B and T cell subsets.
详细描述
The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR113244
Single subcutaneous dose of SAR113244
干预措施: SAR113244 (Drug)
Placebo
Single subcutaneous dose of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline
时间窗: Up to Day 57 after inclusion
次要结局
- Number of participants with anti-SAR113244 antibody titers(Up to Day 198 after inclusion)
- Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)(Up to D198 after inclusion)
- Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)(Up to Day 85 after inclusion)
- Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F)(Up to Day 85 after inclusion)
- Assessment of pharmacodynamics - clinical and/or lupus-related scores(Up to Day 85 after inclusion)
- Assessment of pharmacodynamics - blood/urine parameters(Up to Day 85 after inclusion)
- Assessment of pharmacokinetic parameter - maximum concentration (Cmax)(Up to Day 198 after inclusion)
- Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf)(Up to Day 198 after inclusion)
- Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)(Up to Day 85 after inclusion)
- Number of participants with abnormalities and changes in laboratory parameters(Up to Day 85 after inclusion)
- Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine(Up to Day 198 after inclusion)
- Number of participants with injection site reactions(Up to Day 85 after inclusion)
- Pharmacodynamic parameters: peripheral blood B and T cells subsets(Up to Day 85 after inclusion)