EUCTR2019-003625-16-HR进行中（未招募）1 期
An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study
- •2. Investigator believes may benefit from treatment with ublituximab
- •3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- •4. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 1100
排除标准
- •1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- •a. Absolute neutrophil count < 1.5 x 10e3/µL
- •b. Hematocrit < 24%
- •c. Platelet count < 150,000 cell/mm3
- •d. Hypogammaglobulinemia IgG < 4.0 g/L
- •2. Active infection
- •3. Ongoing pregnancy (female subjects)
- •4. Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period
- •5. Subjects who have completed TG1101-RMS301 or TG1101-RMS302 and for whom more than 180 days have elapsed since the final 96-week assessment.
- •6. Subjects who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301 or TG1101-RMS302 study.
- •7. Subjects who have had a confirmed MS relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, subjects must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE.
- •8. Subjects with unstable disease activity
- •9. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
- •10. Vaccination with live virus within 2 months of randomization
研究者
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