NCT07503873招募中2 期
A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 39
- 主要终点
- Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
研究概览
简要总结
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
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 relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
- •Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
- •Neurologically stable for more than (>) 30 days prior to screening and Day
- •Female participants of childbearing potential must consent to use an 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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- •Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
- •Females who are pregnant or nursing.
- •Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part 2: Ublituximab SC
Experimental
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
干预措施: Prefilled pen (Device)
Part 1: Ublituximab SC
Experimental
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
干预措施: Ublituximab (Drug)
Part 2: Ublituximab SC
Experimental
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
干预措施: Ublituximab (Drug)
结局指标
主要结局
Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
时间窗: Up to Week 12
Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab
时间窗: Up to Week 12
次要结局
- Part 2: Minimum Plasma Concentration (Cmin) of Ublituximab(Up to Week 12)
- Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab(pre-dose and at multiple timepoints post-dose up to Week 120)
- Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab(pre-dose and at multiple timepoints post-dose up to Week 120)
- Part 2 : Minimum Plasma Concentration (Cmin) of Ublituximab(Up to Week 12)
- Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)(Up to Week 96)
- Part 1: Plasma Concentrations of Ublituximab(Up to Week 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Week 120)
研究者
研究点 (39)
Loading locations...
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