NCT06220669招募中2 期
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Parallel-Group Study to Investigate the Safety and Efficacy of LY3541860 Compared to Placebo in Slowing the Occurrence of New T1 Gadolinium-Enhancing Lesions in Adult Participants With Relapsing 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
- 200
- 试验地点
- 50
- 主要终点
- Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better. The study will last about 9 months with additional 6 months follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lublin
- •Participants must have 1 of these:
- •at least 1 documented relapse within the previous year
- •at least 2 documented relapses within the previous 2 years, or
- •at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.
- •Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.
排除标准
- •Have had a diagnosis of:
- •primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2018), or
- •nonactive secondary progressive MS ( Klineova and Lublin 2018).
- •Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
- •Have a history of clinically significant central nervous system (CNS) disease.
- •Have had a confirmed relapse with systemic corticosteroid administration <30 days prior to randomization.
- •Have more than 20 active GdE brain lesions on screening MRI scan.
- •Have received any of these medications or treatments.
- •Have a current or recent acute, active infection.
- •Have current serious or unstable illnesses.
- •Have any other clinically important abnormality at screening or baseline.
研究组 & 干预措施
LY3541860 Phase 2a Dose Level 1
Experimental
LY3541860 will be given intravenously (IV)
干预措施: LY3541860 (Drug)
LY3541860 Phase 2a Dose Level 2
Experimental
LY3541860 will be given IV.
干预措施: LY3541860 (Drug)
Placebo Phase 2a
Placebo Comparator
Placebo will be given IV.
干预措施: Placebo (Drug)
LY3541860 Phase 2b Dose Level 3
Experimental
LY3541860 will be given IV.
干预措施: LY3541860 (Drug)
LY3541860 Phase 2b Dose Level 4
Experimental
LY3541860 will be given IV.
干预措施: LY3541860 (Drug)
Placebo Phase 2b
Placebo Comparator
Placebo will be given IV.
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
时间窗: 12 Weeks
Cumulative number will be measured by magnetic resonance imaging (MRI) scans.
次要结局
- Cumulative Number of New and/or Enlarging T2 Lesions(12 Weeks)
- Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860(Baseline Through Week 12)
- Cumulative Number of Total Number of T1 GdE Lesions(12 Weeks)
研究者
研究点 (50)
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