NCT06413654招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
Shanghai Jiaolian Drug Research and Development Co., Ltd51 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年7月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 51
- 主要终点
- Time to first NMOSD Attack During RCP
研究概览
简要总结
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed NMOSD patients;
- •Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
- •The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
- •Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.
排除标准
- •Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
- •Subjects with chronic active immune system diseases undergoing systematic treatment;
- •Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
- •Received the prescribed drug treatment at the prescribed time before first dose;
- •Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
- •Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
- •Pregnant or lactating women; Subjects with birth plans during the trial;
- •Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
- •Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
- •A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
- •Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;
- •Subjects with severe or persistent infection currently or within the 1 months prior to screening;
- •Subjects with positive gamma interferon release test;
- •Subjects who currently have active hepatitis or have a history of severe liver disease;
- •Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
- •Abnormal laboratory test results;
- •Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
- •Subjects with symptoms of severe mental illness who are clinically uncooperative;
- •Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
研究组 & 干预措施
B001 injection
Experimental
干预措施: B001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Time to first NMOSD Attack During RCP
时间窗: Approximately 48 weeks
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.
次要结局
- Change in Opticospinal Impairment Scale (OSIS)(Approximately 48 weeks)
- Annualized relapse rate (ARR)(Approximately 3 years)
- Change in Expanded Disability Status Scale (EDSS) Score(Approximately 48 weeks)
- Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)(Approximately 48 weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Approximately 3 years)
研究者
研究点 (51)
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