NCT05314010进行中（未招募）3 期
A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年8月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Phase 1b: The incidence and severity of all adverse events (AE)
研究概览
简要总结
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria for NMOSD established by the International Panel for NMO Diagnosis (IPND) in 2015 and are seropositive for AQP4-IgG.
- •Male or female patients aged 18 to 70 years, inclusive of the endpoints..
- •Expanded Disability Status Scale(EDSS) score ≤
- •Phase Ib: At least 1 attack of NMOSD requiring rescue treatment within 2 years prior to screening. Phase III: At least 1 attack of NMOSD requiring rescue treatment within 1 year prior to screening; or at least 2 attacks of NMOSD requiring rescue treatment within 2 years prior to screening, including the first attack.
- •Glucocorticoid treatment prior to screening is allowed, and within 14 days before the first administration, the dose should be ≤20 mg/day of prednisone or its equivalent dose of glucocorticoids.
- •Patients who had an attack of the disease before screening must have stable or improved attack symptoms for at least 4 weeks prior to the first administration.
- •Voluntarily sign the informed consent form.
排除标准
- •Subjects who have received Rituximab, Inebilizumab, Ozanimod, Telitacicept, or any B-cell depleting drugs within 6 months prior to the screening period are allowed to enroll if their CD19 or CD20 positive B-cell counts are above the lower limit of normal; or if their CD4 positive T-lymphocyte counts are < 200 cells/μL.
- •Having used Tocilizumab, Satralizumab, Eculizumab, Efgartigimod, or other non-B-cell depleting biological agents with therapeutic effects on NMOSD, or mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first administration.
- •Phase Ib: Subjects who have used immunosuppressants such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate, and cyclophosphamide before the first administration are eligible for enrollment, provided that the interval since discontinuing the drugs exceeds 5 times their half-life. Phase III: Subjects who have used immunosuppressants other than glucocorticoids within 1 month prior to the first administration, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, and methotrexate, are excluded (exclusion is not required if the continuous use duration is ≤7 days).
- •Within 28 days prior to the first administration, plasma exchange (PE), moderate blood transfusion, or immunomodulatory drugs such as interferon β, interferon γ, or intravenous immunoglobulin (IVIG) have been used.
- •Live vaccines or attenuated vaccines were administered within 28 days prior to the first dose.
研究组 & 干预措施
MIL62
Experimental
干预措施: MIL62 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Phase 1b: The incidence and severity of all adverse events (AE)
时间窗: Up to Week 234
Phase 3: Time to First Adjudicated Relapse (TFR) during RCP.
时间窗: Up to 52 weeks
The time from the date of randomization to the date of the first clinical relapse as assessed by the Clinical Endpoint Committee(CEC). The criteria for NMOSD relapse are the occurrence of new objective neurological symptoms or worsening of objective neurological symptoms; meeting any one of the relapse criteria specified in the protocol is sufficient.
次要结局
- Time to first adjudicated relapse(Up to Week 208)
- Annualized relapse rate(Up to Week 208)
- Change from baseline of Expanded Disability Status Scale (EDSS) score(Up to Week 208)
- Annualized cumulative active lesions rate on MRI(Up to Week 208)
- Annualised NMOSD-related inpatient hospitalisation rate.(Up to Week 208)
- Mean Change in T-score from Baseline in the EQ5D Scale.(Up to Week 208)
- Percentage of Participants with Adverse Events (AEs).(Up to Week 208)
- Peripheral B-cell Counts at Specified Timepoints.(Up to Week 208)
研究者
研究点 (1)
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