NCT06104683撤回2 期
A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients 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
- 撤回
- 试验地点
- 4
- 主要终点
- New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
研究概览
简要总结
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.
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 have been diagnosed with relapsing MS
- •Participants must have one of the following
- •at least 1 documented relapse within the previous year, or
- •at least 2 documented relapse within the previous 2 years, or
- •at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.
排除标准
- •Have had a diagnosis of primary progressive MS
- •Have a history of another clinically significant neurological disease
- •Had a relapse of MS within 30 days prior to randomization.
研究组 & 干预措施
Pirtobrutinib Dose 1
Experimental
Participants will receive pirtobrutinib orally.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib Dose 2
Experimental
Participants will receive pirtobrutinib orally.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib Dose 3
Experimental
Participants will receive pirtobrutinib orally.
干预措施: Pirtobrutinib (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally.
干预措施: Placebo (Drug)
结局指标
主要结局
New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan
时间窗: Week 8 and Week 12
Number of New and/or Enlarging T2 Lesions
时间窗: Week 12
次要结局
- Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib(Baseline to Week 12)
- Total Number of T1 Gd-Enhancing Lesions Per Scan(Week 8 and Week 12)
- Total Number of Gd-Enhancing Lesions Per Scan(Week 8 and Week 12)
研究者
研究点 (4)
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