A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.
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
- •Ability to provide written consent and any authorization required by law.
- •Confirmed diagnosis of AON
- •All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
排除标准
- •Prior episode(s) of optic neuritis or loss of vision not due to AON.
- •Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria.
- •Previous history of a clinically significant disease.
- •Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
- •History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
- •History or evidence of drug or alcohol abuse within 2 years prior to Screening.
- •Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BIIB033
Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
干预措施: BIIB033 (anti-LINGO-1 mAb) (Biological)
Placebo
Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
时间窗: Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Change in FF-VEP Latency at Week 24: Per-protocol Population
时间窗: Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
次要结局
- Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population(Baseline, Week 24)
- Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population(Baseline, Week 24)
- Change in LCLA at Week 24: Per-protocol Population(Baseline, Week 24)
- Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population(Baseline, Week 24)
- Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population(Baseline, Week 24)
- Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population(Baseline, Week 24)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(32 weeks)
- Summary of BIIB033 Concentration(Up to 32 weeks)