NCT02782858已完成2 期
An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
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
- GeNeuro SA
- 入组人数
- 270
- 主要终点
- Cumulative number of Gd-enhancing T1 lesions in brain MRI
研究概览
简要总结
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS).
This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •For male or female with reproductive potential, use of reliable means of contraception;
- •RRMS according to the 2010 revised McDonald criteria;
- •Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
- •EDSS score < 6.
排除标准
- •Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
- •Pregnant and nursing women.
研究组 & 干预措施
Dose 1 GNbAC1
Experimental
Monthly IV repeated dose
干预措施: GNbAC1 (Drug)
Dose 2 GNbAC1
Experimental
Monthly IV repeated dose
干预措施: GNbAC1 (Drug)
Dose 3 GNbAC1
Experimental
Monthly IV repeated dose
干预措施: GNbAC1 (Drug)
Placebo
Placebo Comparator
Monthly IV repeated dose
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative number of Gd-enhancing T1 lesions in brain MRI
时间窗: Week 12 to 24
次要结局
未报告次要终点
研究者
相似试验
终止
2 期
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT03239860GeNeuro SA220
已完成
2 期
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 YearsDiabetes Mellitus Type 1NCT03179423GeNeuro Australia PTY Ltd64
Unknown
3 期
Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal CancerNasopharyngeal CancerNCT01074021Biotech Pharmaceutical Co., Ltd.480
已完成
2 期
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1HIVNCT00784147TaiMed Biologics Inc.113
已完成
1 期
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic MalignancyCancerNCT05040932Eucure (Beijing) Biopharma Co., Ltd8