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 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events and treatment-emergent adverse events
研究概览
简要总结
Primary Objective:
To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.
Secondary Objectives:
To 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-related parameters:
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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 (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive protein.
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Peripheral blood B and T cells subsets.
详细描述
The total duration of screening to end of study per subject is 20 weeks with post-study observation on Day 226 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 cohort 1
Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: SAR113244 (Drug)
SAR113244 cohort 1
Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: placebo (Drug)
SAR113244 cohort 2
Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: SAR113244 (Drug)
SAR113244 cohort 2
Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: placebo (Drug)
SAR113244 cohort 3
Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: SAR113244 (Drug)
SAR113244 cohort 3
Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants with adverse events and treatment-emergent adverse events
时间窗: Up to 16 weeks after inclusion
Change in physical examination, body weight, vital signs and laboratory parameters
时间窗: Up to 16 weeks after inclusion
Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment)
时间窗: Up to 16 weeks after inclusion
次要结局
- Assessment of pharmacokinetic parameter - maximum concentration (Cmax)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)(Up to D113 after inclusion)
- Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)(Up to D113 after inclusion)
- Number of participants with anti-SAR113244 antibody titers(Up to D226 after inclusion)
- Pharmacodynamic parameter changes(Up to D113 after inclusion)
- Pharmacodynamic parameters: peripheral blood B and T cells subsets(Up to D85 after inclusion)