NCT06212245尚未招募4 期
An Open-label Single-arm Clinical Study to Assess the Efficacy and Safety of Inebilizumab in Chinese Adult Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD)
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年2月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percentage of participants with NMOSD attack determined by the investigator
研究概览
简要总结
To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily
- •Men and women 18 years or older
- •Patients with NMOSD diagnosed according to the definition in the Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders in China
- •Patients with positive serum anti-AQP4-IgG results at screening
- •A documented history of one or more NMOSD acute relapses that required rescue therapy within the last year, or 2 or more NMOSD acute relapses that required rescue therapy within 2 years prior to screening
- •Patients with EDSS score of ≤ 7.5 points
- •Patients who and whose sexual partner agree to take highly effective method of contraception from screening
排除标准
- •Patients who have received any of the following treatments at any time prior to randomization:
- •Monoclonal antibodies against CD52: such as alemtuzumab, etc.
- •Total lymphoid irradiation
- •Bone marrow transplant
- •T-cell vaccination therapy
- •Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- •Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- •Patients who have received intravenous injection of immunoglobulin (IVIG) within 1 month prior to randomization;
- •Patients who have received immunosuppressant therapy (e.g., cyclophosphamide, methotrexate, mitoxantrone, ciclosporin A, etc.) and biologics (satralizumab, natalizumab, tocilizumab, eculizumab, etc.) within 3 months or 5 half-lives of such drugs (whichever is longer) before randomization;
- •Any concomitant disease other than NMOSD that required treatment with oral or IV steroids at doses > 20 mg/day for > 21 days within the 6 months prior to screening;
- •Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to enrollment;
- •Severe drug allergic history or anaphylaxis to two or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid); Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy;
- •Patients with evidence of alcohol, drug, or chemical abuse, or with history of such abuse within 1 year prior to randomization;
- •Female patients who are lactating or pregnant, or plan to become pregnant at any time from signing the informed consent through the study plus 6 months following last dose of investigational product;
- •Patients with clinically significant serious active or chronic viral infection, or bacterial infection within 60 days prior to randomization, which requires treatment with anti-infective agents or hospitalization, or might pose an additional risk to the patient in the opinion of the investigator;
- •Patients with known history or underlying disease of primary immunodeficiency (congenital or acquired), such as human immunodeficiency virus (HIV) infection or splenectomy, which predisposes the patient to infection;
- •Confirmed positive serology results of hepatitis B/C at screening
- •Patients with history of malignancy, except squamous or basal cell carcinoma of skin that has been successfully treated with documented success of curative therapy > 3 months prior to randomization;
- •Any other conditions that, in the opinion of the investigator, are not suitable for participating in the clinical study.
研究组 & 干预措施
Inebilizumab
Experimental
Participants will receive IV inebilizumab 300 mg
干预措施: Inebilizumab (Drug)
结局指标
主要结局
Percentage of participants with NMOSD attack determined by the investigator
时间窗: Day 1 (Baseline) through Day 197
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
次要结局
- Percentage of participants with NMOSD attack determined by the investigator(Day 1 (Baseline) through Day 379)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Laboratory measurements as well as their changes or shift as assessed by CTCAE v5.0(Day 1 (Baseline) through Day 379)
- Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score(Day 1 (Baseline) through Day 379)
- Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions(Day 1 (Baseline) through Day 379)
研究者
研究点 (1)
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