An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 11
- 主要终点
- Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
研究概览
简要总结
To evaluate the long-term safety and efficacy of ublituximab therapy in subjects with relapsing forms of MS
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E study.
- •Investigator believes may benefit from treatment with ublituximab
- •Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- •Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception
排除标准
- •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
- •Active infection
- •Ongoing pregnancy (female subjects)
- •Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period OR prior to completing the final Week 208 visit of the TG1101-RMS201E study.
- •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, TG1101-RMS302, OR after the final Week 208 visit of the TG1101- RMS201E study.
- •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.
- •Subjects with unstable disease activity
- •Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
- •Vaccination with live virus within 2 months of randomization
研究组 & 干预措施
ublituximab
Participants receiving ublituximab
干预措施: ublituximab (Drug)
结局指标
主要结局
Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy
MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy
Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score
Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score
No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity
No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity
Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)
Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)
Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies
Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies
次要结局
未报告次要终点
研究者
Clinical Support Team
Scientific
Tg Therapeutics Inc.