NCT04762017已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oculis
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.
研究概览
简要总结
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care
详细描述
ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosed with a unilateral optic neuritis
- •Onset of visual loss symptoms in the last 12 days before randomization
排除标准
- •Optic neuropathy of non-demyelinating origin
- •Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs)
- •Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
- •Active, chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS) or Myelin Oligodendrocyte Glycoprotein Antibody associated Disorder (MOGAD)(e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency)
- •An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss.
- •Diagnosed with macular edema, severe myopia (>6 δ) or other disease of the retina at inclusion
- •Known diabetic retinopathy
- •Known glaucoma
- •Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study.
- •Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration.
- •Breastfeeding or pregnant women
研究组 & 干预措施
OCS-05 +SoC (corticosteroid IV)
Experimental
Once daily IV infusions of OCS-05 + SoC (corticosteroid) (n=18) for 5 consecutive days
干预措施: OCS-05 +SoC (corticosteroid) IV administration (Drug)
Placebo +SoC (corticosteroid IV)
Placebo Comparator
Once daily IV infusions of Placebo + SoC (corticosteroid) (n=18) for 5 consecutive days
干预措施: Placebo + SoC (corticosteroid) IV administration (Other)
结局指标
主要结局
Percentage of patients with shift from normal (baseline) to abnormal in ECG parameters.
时间窗: From Day 1 (V3-t1 after investigational drug administration) to Day 15 (V4)
To determine the shift from normal to abnormal ECG parameters.
次要结局
- Describe the Ganglion Cell and Inner Plexiform Layer (GCIPL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6)(Up to 6 months)
- Describe the Retinal Nerve Fiber Layer (RNFL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6).(Up to 6 months)
- To describe the visual function on the 2.5% ETDRS Low Contrast Letter Acuity (LCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)(Up to 6 months)
- To describe the visual function on the 2.5% ETDRS High Contrast Letter Acuity (HCVA) chart change from baseline (of the affected eye) to each time point (D15, M1, M3, M6)(Up to 6 months)
- To describe the visual function on the Humphrey visual fields evaluations change from baseline (of the affected eye) to each time point (M1, M3, M6)(Up to 6 months)
- To summarize the Visual Evoked Potential latency and amplitude and the change from baseline of the affected eye to each time point (M3 and M6) by treatment group and OCS-05 pooled group(Up to 6 months)
- To summarize the EDSS (Expanded Disability Status Scale) scores and the change from baseline to each time point (M1, M3 and M6) by treatment group and OCS-05 pooled group(Up to 6 months)
- To describe the rate of treatment switch at 6 months for subjects receiving Disease Modifying Therapy (DMT) for multiple sclerosis(6 months)
- To summarize the incidence of safety parameters including clinically notable laboratory abnormalities(Up to 6 months)
- To describe the Cmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1(Day 1)
- To describe the Tmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1(Day 1)
- To describe the AUC0-t of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1(Day 1)
研究者
研究点 (4)
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