A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
研究概览
简要总结
Primary Objective:
- To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis.
Secondary Objectives:
- To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
- To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
详细描述
The duration of study per patient will be approximately 61 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Acyclovir (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Methylprednisolone (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: alemtuzumab GZ402673 (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Paracetamol (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Loratadine (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Ceterizine (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Paracetamol (Drug)
alemtuzumab (subcutaneous injection)
Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Dexchlorpheniramine (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Acyclovir (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Methylprednisolone (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: alemtuzumab GZ402673 (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Loratadine (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Ceterizine (Drug)
alemtuzumab (intravenous infusion)
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
干预措施: Dexchlorpheniramine (Drug)
结局指标
主要结局
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
时间窗: Baseline, 30 days after each treatment course
次要结局
- Change from baseline in helper/suppressor ratio after alemtuzumab administration(Baseline, 30 days after each treatment course)
- Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax)(30 days after each treatment course)
- Change from baseline in lymphocyte subsets after alemtuzumab administration(Baseline, 30 days after each treatment course)
- Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration versus time curve from time zero until the last measurable concentration (AUClast)(30 days after each treatment course)
- Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z)(30 days after each treatment course)
- Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC)(30 days after each treatment course)
- Number of patients with adverse events of special interest(4 years)
- Change from baseline in total lymphocyte count after alemtuzumab administration(Baseline, 30 days after each treatment course)
- Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax)(30 days after each treatment course)
- Number of patients with adverse events(4 years)
- Number of patients with injection site reactions(2 years)