NCT07211633进行中（未招募）3 期
A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 48
- 主要终点
- Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
详细描述
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RMS (2017 Revised McDonald criteria).
- •Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- •Neurologically stable for > 30 days prior to Screening and Day
- •Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.
排除标准
- •Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
- •Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- •Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- •Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- •Note: Other Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Ublituximab IV
Active Comparator
Approved dosage.
干预措施: Ublituximab (Biological)
Ublituximab SC Regimen 1
Experimental
New regimen.
干预措施: Ublituximab (Biological)
Ublituximab SC Regimen 2
Experimental
New regimen.
干预措施: Ublituximab (Biological)
结局指标
主要结局
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
时间窗: Up to Week 24
次要结局
- Participants B Cell Counts(Up to Week 120)
- Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan(Up to Week 96)
- Total Number of New or Enlarging T2 lesions Per MRI Scan(Up to Week 96)
- Minimum Plasma Concentration (Cmin) of Ublituximab(Up to Week 24)
- Average Concentration at Steady State (Cavg,ss) of Ublituximab(Up to Week 120)
- Maximum Plasma Concentration (Cmax) of Ublituximab(Up to Week 120)
- Time to Maximum Plasma Concentration (Tmax) of Ublituximab(Up to Week 120)
- Last Observed Concentration (Clast) of Ublituximab(Up to Week 120)
- Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab(Up to Week 120)
- Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab(Up to Week 120)
- Time of Last Concentration (Tlast) of Ublituximab(Up to Week 120)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Up to Week 120)
研究者
研究点 (48)
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