A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 47
- 主要终点
- Cumulative number of new GdE T1 hyperintense lesions
研究概览
简要总结
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
详细描述
The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).
Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, Care Providers, Investigator, Outcomes Assessor
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
- •An EDSS of ≤ 5.5 at the Screening Visit
- •Must have documentation of:
- •. at least 1 relapse within the previous year OR
- •. ≥ 2 relapses within the past 2 years OR
- •. ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
- •Not of childbearing potential or willing to follow contraceptive guidance
排除标准
- •Primary progressive MS or secondary progressive MS without relapses
- •Meet criteria for neuromyelitis optica spectrum disorder
- •Relapse in the 30 days prior to randomization
- •≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
- •Has > 20 Gd+ lesions on brain MRI at screening
研究组 & 干预措施
Obexelimab
Obexelimab will be administered as a subcutaneous injection for 76 weeks
干预措施: Obexelimab (Drug)
Placebo
Placebo will be administered as a subcutaneous injection for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative number of new GdE T1 hyperintense lesions
时间窗: Week 8 and Week 12
Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
次要结局
- Volume of T2 lesions(Week 12)
- Number of T2 Lesions(Week 8 and Week 12)
- Number of GdE T1 lesions(Week 4, Week 8, and Week 12)
- Serum NfL(Week 12)
- Incidence of Adverse Events, injection site reactions and hypersensitivity reactions(24 weeks)