A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- GeNeuro SA
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Long term safety of GNbAC1
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.
The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
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
- •Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study
- •Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
- •Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.
排除标准
- •Patients not having completed the study GNC-003
- •Pregnancy
- •The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms
研究组 & 干预措施
Dose 1 GNbAC1
Monthly IV
干预措施: GNbAC1 Monoclonal Antibody (Drug)
Dose 2 GNbAC1
Monthly IV
干预措施: GNbAC1 Monoclonal Antibody (Drug)
Dose 3 GNbAC1
Monthly IV
干预措施: GNbAC1 Monoclonal Antibody (Drug)
结局指标
主要结局
Long term safety of GNbAC1
时间窗: 96 Weeks
The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
次要结局
- Long term efficacy of GNbAC1 in terms of disease progression(96 Weeks)
- Long term efficacy of GNbAC1 in terms of MRI outcomes(96 Weeks)
- Long term efficacy of GNbAC1 in terms of disability(96 Weeks)
- Long term efficacy of GNbAC1 in terms of relapse rate(96 Weeks)