Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD): a Multicenter, Randomized, Open-label, Positive-controlled, Two-stage Exploratory Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety, of JYP0061 in acute NMOSD patients. The main questions it aims to answer are: efficacy and safety of JYP0061 in acute NMOSD patients. Participants will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids or high-dose JYP0061. Efficacy and safety evaluations will be conducted according to the protocol.
详细描述
This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neuromyelitis spectrum disease (NMOSD) patients according to 2015 International consensus diagnostic criteria.
- •Positive Aquaporin 4 immunoglobulin G (AQP4-IgG)
- •Patients with acute NMOSD
- •Female serum pregnancy test results were negative at the time of screening, subject (including partner) had no child-rearing plan and voluntarily adopted double contraceptive (non-oral contraceptives) within 6 months from screening to the last study drug administration, and had no sperm/egg donation plan;
- •Have fully understood this study, voluntarily participate in the experiment, and voluntarily sign the written informed consent.
排除标准
- •Pregnant or lactating women;
- •Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution;
- •Symptoms improved in the acute phase before the study drug was used;
- •Unable to complete MRI or gadolinium enhanced examination;
研究组 & 干预措施
Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)
Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time.
干预措施: JYP0061 (Drug)
Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)
Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time.
干预措施: Intravenous Glucocorticoids (Drug)
Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)
Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time.
干预措施: Oral Glucocorticoids (Drug)
Standard Dose Glucocorticoids (Groups B1 and B2)
Participants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response.
干预措施: Intravenous Glucocorticoids (Drug)
Standard Dose Glucocorticoids (Groups B1 and B2)
Participants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response.
干预措施: Oral Glucocorticoids (Drug)
High-dose JYP0061 (Group C)
Participants in this group will receive a higher dose of JYP0061 for the initial weeks, followed by a lower maintenance dose for the remainder of the study period.
干预措施: JYP0061 (Drug)
结局指标
主要结局
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
时间窗: 6 weeks after the first administration of the medication.
This outcome assesses the clinical efficacy of JYP0061 in acute-phase NMOSD patients. The proportion of participants achieving various levels of recovery-Complete Recovery (CR), Good Recovery (GR), Moderate Recovery (MR), and Poor Recovery (PR)-will be evaluated based on the Expanded Disability Status Scale (EDSS) after 6 weeks of treatment.
次要结局
- Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants(Weeks 2, 4, 6, 14, and 26.)
- Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants(Weeks 2, 4, 6, 14, and 26.)